UNITED STATES PATENT AND TRADEMARK OFFICE
`
`______________________
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`
`
`IN THE UNITED STATES PATENT TRIAL AND APPEAL BOARD
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`______________________
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`
`
`ENDOLOGIX, INC.
`Petitioner
`
`v.
`
`LIFEPORT SCIENCES LLC
`Patent Owner
`
`______________________
`
`CASE IPR: 2015-01722
`U.S. PATENT NO. 8,192,482
`______________________
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`DECLARATION OF RICHARD A. HILLSTEAD, PH.D
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` 1
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`
`
`______________________
`
`
`
`IN THE UNITED STATES PATENT TRIAL AND APPEAL BOARD
`
`______________________
`
`
`
`ENDOLOGIX, INC.
`Petitioner
`
`v.
`
`LIFEPORT SCIENCES LLC
`Patent Owner
`
`______________________
`
`CASE IPR: 2015-01722
`U.S. PATENT NO. 8,192,482
`______________________
`
`DECLARATION OF RICHARD A. HILLSTEAD, PH.D
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` 1
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`I, Richard A. Hillstead, Ph.D, do hereby declare and say:
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`1.
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`I am over the age of twenty-one (21) and competent to make this
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`declaration. I am also qualified to give testimony under oath. The facts and
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`opinions listed below are within my personal knowledge.
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`2.
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`I am being compensated for my time in this proceeding at my
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`standard consulting rate of $500.00/hr. My compensation in no way depends on
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`the outcome of this proceeding or the content of my opinions. I am not
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`employed by, nor receiving grant support from, Endologix, Inc., which I refer to
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`as “Endologix”, or any of its related companies. I am receiving compensation
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`from Endologix solely for my involvement in this matter and based only on my
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`standard hourly consulting fees.
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`3.
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`I have been asked to review certain documents, including U.S.
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`Patent No. 8,192,482 and its prosecution history (which I refer to as the ‘482
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`Patent) (Ex. 1001), and to provide my opinions on what those documents
`
`disclose. The other documents I was asked to review include those addressed in
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`more detail in the rest of this declaration.
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`4.
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`Of particular relevance to the ‘482 Patent, I have reviewed and am
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`familiar with the following documents:
`
`a.
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`U.S. Patent No. 8,317,854 to Ryan et al. which is marked as
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`Ex. 1004. I refer to this document as the Ryan Patent.
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`
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` 2
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`
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`b.
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`U.S. Patent No. 5,405,377 to Cragg, which is marked as Ex.
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`1005. I refer to this document as the Cragg Patent.
`
`c.
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`U.S. Patent No. 5,064,435 to Porter, which is marked as Ex.
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`1006. I refer to this document as the Porter Patent.
`
`d.
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`U.S. Patent No. 4,994,071 to MacGregor, which is marked
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`as Ex. 1007. I refer to this document as the MacGregor Patent.
`
`e.
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`U.S. Patent No. 5,135,536 to Hillstead, which is marked as
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`Ex. 1008. I refer to this document as the Hillstead Patent.
`
`f.
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`U.S. Patent No. 4,733,665 to Palmaz, which is marked as Ex.
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`1009. I refer to this document as the Palmaz Patent.
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`g.
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`U.S. Patent No. 5,370,683 to Fontaine, which is marked as
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`Ex. 1010. I refer to this document as the Fontaine Patent.
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`h.
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`U.S. Patent No. 5,707,386 to Schnepp-Pesch et al., which is
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`marked as Ex. 1011. I refer to this document as the Schnepp-Pesch
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`Patent.
`
`i.
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`U.S. Patent No. 5,421,955 to Lau et al., which is marked as
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`Ex. 1012. I refer to this document as the Lau Patent.
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`j.
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`The Prosecution History of U.S. Patent No. 8,192,482.
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`5.
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`I provide my conclusions regarding the disclosures of the
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`documents I reviewed as applied to the ‘482 Patent below.
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` 3
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`6.
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`I was also asked to provide my opinion on the technical feasibility
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`of combining certain aspects of certain documents. I have offered my opinion
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`on the feasibility of these combinations in this declaration. I have also offered
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`my opinions about what a person of ordinary skill in the art would understand
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`about certain aspects of the resulting combinations of documents.
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`7.
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`I am not offering any conclusions as to the ultimate determinations
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`I understand the Patent Trial and Appeals Board will make in this proceeding.
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`Specifically, I am not offering opinions on ultimate issues of validity or claim
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`construction. I am simply providing my opinion on the technical aspects of the
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`documents and on the combinability of the concepts disclosed in those
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`documents from a technical perspective.
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`BACKGROUND
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`8.
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`A copy of my curriculum vitae is attached to this declaration as Ex.
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`1003.
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`9.
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`I hold an M.B.A. and B.S. from Nova Southeastern University and
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`a Ph.D. in Business Administration from Southwest University. I am a Fellow
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`of the American Heart Association (FAHA) on the Council of Clinical
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`Cardiology and the Council on Lifestyle and Cardiometabolic Health .
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`10. Since approximately the mid-1980’s, I have been actively involved
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`in the design and development of medical devices, including stent technologies.
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` 4
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`
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`11. From 1987 to 1993, I held several progressive, product research
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`and development positions with Cordis Corporation, a division of Johnson &
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`Johnson, which is known as a leader in the development and manufacture of
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`stent technologies. From 1988 through 1990 I was a Senior Research Engineer
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`in the Corporate Research Stent Program.
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`12. From 1993 to 1999 I was employed by Novoste Corporation, a
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`company focused on developing treatment for coronary and vascular diseases
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`and restenosis.
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` I directed new technology and intravascular catheter
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`development for Novoste from 1993 to 1999 and in that position worked closely
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`with stents and stent technologies.
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`13. Although not a medical doctor, I have personally “scrubbed in” and
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`actively participated in more than one hundred coronary interventions including
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`coronary stenting in various animal models.
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`14.
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`I am currently a partner in Georgia Venture Partners, a venture
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`capital firm that invests in life sciences companies with a connection to Georgia.
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`15. Prior to my role with Georgia Venture Partners, I was a founding
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`member of The Innovation Factory (TIF) and a principal partner in Accuitive
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`Medical Ventures I and II (“Accuitive”). Both TIF and Accuitive work with
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`companies to develop promising medical technologies. At TIF I served as Chief
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`Science Officer and was primarily responsible for technical due diligence
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` 5
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`
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`(including
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`intellectual property review), deal structure, and
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`technology
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`development in the areas of Interventional Cardiology and Orthopedics.
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`16.
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`I am an inventor named on approximately seventy-five (75) issued
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`U.S. patents and patent applications and dozens of international patents,
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`including patents related to stent technologies. My intellectual property has
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`been referenced in over four thousand issued and pending U.S. patents and I
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`have been directly responsible for the development of numerous, commercially
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`successful vascular medical devices.
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`17.
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`I have authored
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`textbook chapters, and numerous
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`journal
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`publications, many of which focus on stents and stent design.
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`18.
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`I am competent to make this declaration based upon my personal
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`knowledge and technical expertise in the area of medical device design,
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`including the design of cardiovascular stents.
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`LEVEL OF SKILL IN THE ART
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`19.
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`I understand that one of the relevant factors in this proceeding is
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`the level of skill in the pertinent art. I understand that the pertinent date for this
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`determination is date of alleged invention. For purposes of this declaration, I
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`have been asked to assume that the date of invention for the ‘482 Patent is
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`September 27, 1994.
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`20.
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`In my opinion, a person of ordinary skill in the art as of September
`
`27, 1994, would have had a bachelor of science degree in mechanical
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`
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` 6
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`
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`engineering, or the equivalent, or would have had at least five years’ experience
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`in designing stents. Based on my education, background and experience in the
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`field of stent design, I would qualify as a person of ordinary skill in the art as of
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`the date of the alleged invention.
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`CLAIM CONSTRUCTION
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`21.
`
`It is my understanding that in order to properly evaluate the ‘482
`
`Patent, the terms of the claims must first be interpreted. In my analysis and
`
`opinions below, I applied the following claim constructions.
`
`Claim(s)
`1-9, 12-13,
`21-22
`
`Claim Term
`“non-helical”
`
`non-spiral
`
`Construction
`
`1-9, 12-13,
`21-22
`
`“means for
`securing”
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`Function: Securing the apex of one
`hoop to a juxtaposed apex of a
`neighboring hoop.
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`Structure:
`formed of
`loop
`(1)
`thermoplastic material; (2) a suture;
`(3) bead formed of a thermoplastic
`material; (4) loop formed of wire; (5)
`ring formed of wire; and (6) staple
`formed of wire; and equivalents.
`
`2-5,8-9, and
`12
`
`“segment”
`
`portion
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`I do not believe that my analysis would change even if the Board does not adopt
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`these constructions. It is my understanding that the remaining claim terms are
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`given their ordinary and accustomed meaning as would be understood by one of
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`ordinary skill in the art.
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`
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` 7
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`
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`BACKGROUND OF THE TECHNOLOGY
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`22. The ‘482 Patent describes an endoluminal prosthesis for use in a
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`blood vessel. For decades, doctors have used stents, grafts and prostheses for
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`the treatment of angiologic diseases.
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`23. A “prosthesis,” as used in this case, is a stent (the wire portion)
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`with a graft (the fabric portion) covering it. A prosthesis is used to provide a
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`prosthetic intraluminal wall because it allows the blood flow to flow within it.
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`24. A prosthesis can be used to treat an aneurysm by removing the
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`pressure on a weakened part of an artery, thus reducing the risk of embolism, or
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`of the natural artery wall bursting.
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`25. Stents, grafts and prostheses date back to 1980’s. See, e.g., Ex.
`
`1009. By 1994, a wide variety of stent designs were well known in the art. The
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`well known stents were typically tubular and could include extensions,
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`bifurcations, and extensions for the bifurcations. The well known tubular
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`structures were made out of a filament (typically wire) that could take on a
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`variety of patterns to provide various advantages such as strength, stability, and
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`flexibility.
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`26. One way to categorize the well known patterns was to classify a
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`design as helical or non-helical. Both helical and non-helical patterns often took
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`on a well known zig-zag pattern whereby the wire forming the stent looped
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`around an axis in a repeating zig-zag pattern to form a cylinder. Prior art stent
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`
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` 8
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`
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`designs that were helical (e.g., EP-A-0556850) and non-helical (U.S. Patent No.
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`4,733,655) utilized this zig-zagging pattern.
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`27. The ‘482 Patent explicitly recognized the existence of this well
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`known prior art pattern, the zig-zag pattern which can be helical or non-helical.
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`The ‘482 Patent recognized this design as being helical (e.g., EP-A-0556850)
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`and non-helical (U.S. Patent No. 4,733,655)
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`PRIOR ART DESIGNS
`
`28. The Cragg Patent, provides a well known example of a prior art
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`helical design. The zig-zaging pattern in Cragg gradually works its way down
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`the length of the cylinder in helical fashion. See Ex. 1005 at Fig. 1. The apices
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`of the zigs and zags are not aligned perpendicular to the longitudinal axis of the
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`stent.
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`29. The Fontaine Patent also discloses a helical pattern. Figure 7 of
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`Fontaine depicts a partially unwound helical pattern. See Ex. 1010 at Fig. 7.
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`30. Non-helical patterns were also very well known at the time. For
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`example, the Hillstead Patent, the Schnepp-Pesch Patent, the Ryan Patent, and
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`the Palmaz Patent all disclose stents that include non-helical zig-zaging patterns
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`that make a series of loops around the longitudinal axis, where each loop is in a
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`plane perpendicular to the axis. Ex. 1008 at Fig. 2; Ex. 1009 at Fig. 1A; Ex.
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`1011 at Fig.2; Ex. 1004 at Fig. 2.
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`
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` 9
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`
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`31. The ‘482 Patent attempts to claim the well known non-helical stent
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`design by acknowledging both helical and non-helical designs in the
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`background of the specification of the ‘482 Patent, but then in the summary
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`focusing on differentiating the alleged invention of the ‘482 Patent from the
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`well known helical designs without acknowledging the equally well known non-
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`helical designs.
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`32. Based on my experience in the field and the prior art discussed
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`below, the “substantially perpendicular” or non-helical configuration described
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`in the ‘482 Patent was not novel. As stated above, it was common and well
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`known in the prior art. Ex. 1008 at Fig. 2; Ex. 1009 at Fig. 1A; Ex. 1011 at
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`Fig.2; Ex. 1004 at Fig. 2.
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`33. The ‘482 Patent specification describes both helical and non-helical
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`embodiments. ‘482 Patent at 3:62-4:7. Importantly, the ‘482 Patent and the
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`prior art make clear that well known elements disclosed as part of helical stents
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`could often be substituted into non-helical stents. Thus, there was nothing novel
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`about the claimed “non-helical” hoop stent of the ‘482 Patent.
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`34. For example, as shown in the Ryan Patent and the Cragg Patent,
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`both helical and non-helical prior art stents can have zig-zag patterns whereby
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`adjacent apices abut. Ex. 1004 at Fig. 2; Ex. 1005 at Fig. 1. These patterns
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`were well known in the prior art and, as discussed below, various means for
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`securing abutting apices was also well known in the prior art.
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`
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`10
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`
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`35. Additionally, it was well known that those securing means were
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`interchangeable not only with one another, but between helical and non-helical
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`designs. In my opinion, one of skill in the art would have been capable of
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`implementing the securing means from the non-helical design of the Cragg
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`Patent into the helical design of the Ryan Patent. This is so because both
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`securing means were well known in the field for securing adjacent apices, and
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`thus could be simply substituted for one another.
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`36.
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`In sum, in the 1994 timefame, there was nothing novel about using
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`a helical design, nothing novel about using a non-helical design, and nothing
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`novel about implementing well known prior art elements into either helical or
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`non-helical designs.
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`37. The ‘482 Patent claims “means for securing an apex of one hoop to
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`an abutting a juxtaposed apex of a neighboring hoop.” This was a well known
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`prior art feature of both helical and non-helical stent designs.
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`38.
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`It was common practice to align the apices of one layer of zig-zags
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`with the apices of an adjacent layer of zig-zags in both helical and non-helical
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`stent designs. It was well known to align apices in order to secure the layers
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`together at the apices where the securing means would be most effective. This
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`practice was well known as early as the 1980s by virtue of, at least, Palmaz. Ex.
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`1009 at 6:36-52.
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`
`
`11
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`
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`39. A variety of well known means for securing apices had been
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`established prior to the filing date of the ‘482 Patent. The various securing
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`means all shared a common function: to secure an apex of one hoop to an apex
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`of a neighboring hoop.
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`40. The ‘482 Patent acknowledged that such means for securing were
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`well known prior art elements at the time of the alleged invention and did not
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`characterize them as new or novel, as seen here: “Typically, the stents of this
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`invention whether of the helical or perpendicular variety, also comprise a
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`securing means for securing an apex of the sinuous wire in one hoop to a
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`juxtaposed apex of a neighboring hoop so that each hoop is supported by its
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`neighbors.” ‘482 Patent at 4:21-25.
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`41. The Palmaz Patent, the Fontaine Patent, the Cragg Patent, and the
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`Lau Patent disclose several of the well known prior art structures for securing
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`apices. They also recognize the interchangeability of such structures.
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`42. Palmaz discloses use of “welding, soldering, or gluing” or any
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`other “conventional manner” for securing apices in order to provide “a
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`relatively high resistance to radial collapse” and to allow the stent to retain its
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`shape. Ex. 1009 at 6:36-49.
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`43. Fontaine discloses using a loop or a staple-like bracket to secure
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`apices in addition to brazing, welding or gluing: “In practice, the connection
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`between the loop and the filament is slidable along the filament 11, thereby
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`
`
`12
`
`
`
`allowing for radial expansion. Although this connection can be easily made
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`using a loop as shown, it can also be made by, for example, using a bracket or
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`clip. The connector could also be made by brazing, welding, or gluing the end
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`to the filament.” Ex. 1010 at 4:59-63.
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`44. Cragg discloses using “loops which connect adjacent apices of the
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`wire.” Ex. 1005 at Abstract. Cragg further discloses “loop members 12 which
`
`connect adjacent apices of adjacent helix hoops to help define the tubular stent.
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`The loop members 12 may connect all or some of the pairs of adjacent apices.”
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`Id. at 2:42-47. This disclosure is further depicted in the figures of Cragg. See
`
`id. Figs. 2-4.
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`45. Lau discloses that the apices may be secured integrally or by
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`independent means: “The interconnecting elements may be formed in a unitary
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`structure with the expandable cylindrical elements from the same intermediate
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`product, such as a tubular element, or they may be formed independently and
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`connected by suitable means, such as by welding or by mechanically securing
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`the ends of the interconnecting elements to the ends of the expandable
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`cylindrical elements.” Ex. 1012 at 2:59-66.
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`46.
`
`In addition to the specific references noted above, a wide variety of
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`securing means were well known to one of skill in the art at the time of alleged
`
`invention.
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`
`
`13
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`
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`GROUNDS FOR INVALIDITY
`
`47.
`
`I have read and reviewed the petition by Endologix for inter partes
`
`review of claims 1-9, 12-13, 21-22, and 30 of the ‘482 Patent. I have also
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`reviewed all asserted grounds for invalidity. To the extent I have not otherwise
`
`stated, I agree with each of the asserted grounds and the rational underpinning
`
`of each anticipation and obviousness combination from the standpoint of person
`
`of ordinary skill in the art.
`
`48. As part of my work in this matter, I have been asked to consider
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`whether a person of skill in the art could have combined the prior art references
`
`in various permutations from a technical perspective, or whether the reference
`
`on its own contains all of the claimed elements.
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`49. Specifically, I have been asked to consider whether the following
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`combinations would or could have been made by a person of ordinary skill in
`
`the art: (1) the Ryan Patent combined with the Cragg Patent; (2) the Ryan Patent
`
`combined with the Porter Patent; (3) the Ryan Patent combined with the
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`MacGregor Patent; (4) the Hillstead Patent combined with the Palmaz Patent;
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`and (5) the Hillstead Patent combined with the Palmaz Patent, and the Ryan
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`Patent.
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`50.
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`I will now walk through each asserted ground in order to provide
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`my understanding of the prior art technology as compared to the claimed
`
`invention, and my understanding of the knowledge a person of ordinary skill in
`
`
`
`14
`
`
`
`the art as of the date of alleged invention would have had. As explained in
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`detail below, each of these combinations is well within the technical capabilities
`
`of a person having ordinary skill in the art.
`
`Ground 1: Claims 1-9, 12-13, 21-22, and 30 Are Anticipated by the Ryan
`Patent
`
`51.
`
`In my opinion, the Ryan Patent discloses each and every one of the
`
`elements of claims 1-9, 12-13, 21-22, and 30, anticipating those claims.
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`52. The Ryan Patent describes a stent made up of either non-helical or
`
`helical elements. Ex. 1004 at 5:24-30. Specifically, the Ryan Patent discloses
`
`that “[t]he radially compressible frame can take a variety of forms, usually
`
`comprising or consisting of a plurality of independent or interconnected
`
`structural elements, such as rings, bands, helical elements, serpentine elements,
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`axial struts, parallel bars, and the like.” Ex. 1004 at 5:24-30. The preferred
`
`embodiments of the Ryan Patent depict and describe non-helical rings (i.e.,
`
`hoops).
`
`53. The Ryan Patent explicitly states that “[t]he tubular frame
`
`preferably comprises a plurality of radially compressible band or ring
`
`structures.” Ex. 1004 at 3:16-17. The Ryan Patent portrays its “band or ring
`
`structures” as non-helical rings that are each oriented in a plane perpendicular to
`
`the axis of the stent. See, eg., Ex. 1004 at Fig. 2. The Ryan Patent discloses
`
`that “band members 11, each [] comprise[] a zig-zag or Z-shaped element which
`
`forms a continuous circular ring.” Ex. 1004 at 7:49-52.
`
`
`
`15
`
`
`
`54. For example, Figure 2 of the Ryan Patent depicts a series of axially
`
`aligned hoops (“band members 11”), each oriented in a plane perpendicular to
`
`the longitudinal axis of the stent. See Ex. 1004 at Fig. 2. The Ryan Patent also
`
`describes and shows that its hoops are oriented in a conventional “zig-zag”
`
`pattern constructed of elongate elements that meet at apices and shows that the
`
`apices point in a direction along the longitudinal axis of the stent. Ex. 1004 at
`
`7:49-51, Figs. 1-5.
`
`55. Therefore, it is my opinion that the Ryan Patent discloses claim 1’s
`
`limitations of “a plurality of hoops aligned along a common axis,” “each of said
`
`hoops being non-helical and oriented in a plane substantially perpendicular to
`
`the longitudinal axis of the stent,” and “each of said hoops including a plurality
`
`of elongate elements joined to one another and forming apices that point in a
`
`direction along the longitudinal axis of the stent.” See Ex. 1004 at 3:16-19,
`
`7:49-61, Figs. 1-5.
`
`56. The Ryan Patent further discloses the limitation “at least one
`
`elongate element in each hoop is a continuation of an elongate element of an
`
`adjacent hoop.” Specifically, the Ryan Patent discloses “junctions” where
`
`elongate elements of one hoop continue over into elongate elements of an
`
`adjacent hoop. Ex. 1004 at 7:54-59, 8:41-43, Figs. 1-5.
`
`57. The Ryan Patent is clear that “[a]djacent compressible band
`
`members . . . may be joined at one or more locations therebetween.” Ex. 1004
`
`
`
`16
`
`
`
`at 3:19-21. The Ryan Patent also discloses that “the bands are preferably joined
`
`at [] diametrically opposed points,” i.e., apices. Ex. 1004 at 3:22-23. The Ryan
`
`Patent‘s “bridge element” preforms an identical function as claim 1’s “means
`
`for securing,” i.e., it secures the apex of one hoop to a juxtaposed apex of a
`
`neighboring hoop. Ex. 1004 at 3:19-23, 7:49-57, Figs. 1-5.
`
`58. While the structure of the Ryan Patent’s “bridge element 13” may
`
`not identical to the structures disclosed in the ‘482 Patent, the ‘482 Patent does
`
`not make any statements that would foreclose on the Ryan Patent’s “bridge
`
`element 13” being an equivalent structure such that it anticipates this element.
`
`59. Therefore, it is my opinion that the Ryan Patent discloses the
`
`limitation “means for securing an apex of one hoop to an abutting juxtaposed
`
`apex of a neighboring hoop.”
`
`60. Claim 2 depends from claim 1 and requires that “at least one stent
`
`segment in combination with one or more additional stent segments.” The Ryan
`
`Patent discloses several variations of a stent segment in combination with
`
`additional stent segments.
`
`61. First, the Ryan Patent discloses that its “tubular frame” (stent) may
`
`be constructed of multiple stent segments with varying properties. Ex. 1004 at
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`6:62-7:39. The Ryan Patent discloses that “some circumferentially spaced-apart
`
`segments of the tubular frame could be malleable while the remaining
`
`circumferential segments would be elastic.” Ex. 1004 at 7:19-22. This can be
`
`
`
`17
`
`
`
`achieved “by forming circumferential segments of the frame from different
`
`materials having different elastic/malleable properties.” Ex. 1004 at 7:32-36.
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`Therefore, it is my opinion that by this disclosure alone, the Ryan Patent
`
`anticipates claim 2.
`
`62. The Ryan Patent discloses in Figure 2 a bifurcated stent structure
`
`where a base stent segment 20 is used in combination with additional leg
`
`segments 10. Ex. 1004 at 10:23-50; see also Figs. 7-12. Therefore, it is my
`
`opinion that by this disclosure alone, the Ryan Patent anticipates claim 2.
`
`63. Claim 3 depends from claim 2 and requires that “said one or more
`
`additional segments are axially aligned with one another.” The Ryan Patent’s
`
`discloses segments of its tubular member with “different elastic or other
`
`mechanical properties at different regions along its length.” Ex. 1004 at 6:62-
`
`7:39.
`
`64. The Ryan Patent provides a specific example of a “malleable” end
`
`segment and an “elastic” middle segment. Ex. 1004 at 6:67-7:8. The Ryan
`
`Patent contemplates these segments would be part of the same tubular member
`
`and thus share a longitudinal axis. Ex. 1004 at 6:62-7:39. Therefore, it is my
`
`opinion that the Ryan Patent discloses that “said one or more additional
`
`segments are axially aligned with one another,” and anticipates claim 3.
`
`65. Figure 12 of the Ryan Patent shows that the additional leg
`
`segments 10 of the bifurcated device are axially aligned with the body segment
`
`
`
`18
`
`
`
`20. Therefore, it is my opinion that by this disclosure the Ryan Patent
`
`anticipates claim 3.
`
`66. Claim 4 depends from claim 3 and requires that “said axially
`
`aligned segments are connected to one another by a tubular fabric element.”
`
`The Ryan Patent’s stent segments with “different elastic or other mechanical
`
`properties,” described above, are connected by a tubular fabric element(s). The
`
`Ryan Patent discloses tubular fabric elements traversing the interior and exterior
`
`of its stent. Ex. 1004 at 7:62-9:5, Figs. 1, 1A.
`
`67. The Ryan Patent discloses a “fabric liner 12” in Figure 1. Ex. 1004
`
`at 7:40-48, Fig. 1. The Ryan Patent also discloses an “outer liner 110” in
`
`conjunction with “inner liner 108” in Figure 1A. Ex. 1004 at 8:47-9:5, Fig. 1A.
`
`In each of these embodiments, the stent segments are connected by the inner
`
`and/or outer “tubular fabric element” which are “stitched or otherwise secured
`
`to the band members 11, preferably at the junctions or nodes.” Ex. 1004 at
`
`7:64-67, Figs. 1, 1A. The Ryan Patent also discloses that the additional leg
`
`segments 10 of the bifurcated device shown in Figure 12 are connected to the
`
`body segment 20 by tubular fabric elements 26, 28. Ex. 1004 at 10:23-50, Figs
`
`7-12. Therefore, it is my opinion that by each of these disclosures, the Ryan
`
`Patent anticipates claim 4.
`
`68. Claim 5 depends from claim 2 and requires that “said one or more
`
`additional segments are secured to one another by connecting means connecting
`
`
`
`19
`
`
`
`at least some of the apices of hoops at mating ends of said stent and said
`
`additional segments.” The Ryan Patent’s stent segments with “different elastic
`
`or other mechanical properties,” described above, may be secured to one
`
`another by connecting means connecting at least some of the apices of hoops at
`
`mating ends, as depicted in Figures 1-5 of the Ryan Patent.
`
`69. The Ryan Patent also discloses that “some circumferentially
`
`spaced-apart segments of the tubular frame could be malleable while the
`
`remaining circumferential segments would be elastic.” Ex. 1004 at 7:19-22.
`
`The end most hoops or bands of each segment are connected in the same
`
`manner as generally disclosed hoops or bands, i.e., by connecting elements 13.
`
`Ex. 1004 at 7:54-57, Figures 1-2; see also id. at 6:67-7:17, Figs. 3-5. Therefore,
`
`it is my opinion that by these disclosures, the Ryan Patent anticipates claim 5.
`
`70. Claim 6 depends from claim 2 and requires that “adjacent hoops
`
`are of the same diameter.” This claim does not modify the elements added by
`
`claim 2, but rather refers to the claimed “hoops” of claim 1. As shown
`
`throughout, the main tubular member of the Ryan Patent is depicted as having
`
`adjacent hoops (band members 11) of the same diameter. Ex. 1004 at Figs. 1-5.
`
`The Ryan Patent also discloses that adjacent hoops of separate segments are of
`
`the same diameter. See analysis of claim 5 above; Ex. 1004 at 6:67-7:17, Figs.
`
`1-5. Therefore, it is my opinion that by these disclosures, the Ryan Patent
`
`anticipates claim 6.
`
`
`
`20
`
`
`
`71. Claim 7 depends from claim 2 and requires that “adjacent hoops
`
`are of a different diameter.” Figure 12 of the Ryan Patent depicts integrally
`
`larger hoop diameters from the proximal end to the distal end of stent 10.
`
`Because the diameters of the proximal most hoop and the distal most hoop are
`
`different, at least one set of adjacent hoops must be of a different diameter. It
`
`appears that the diameter of the hoops increases gradually, and thus, each set of
`
`adjacent hoops are of a different diameter in this embodiment. Ex. 1004 at Fig.
`
`12. Therefore, it is my opinion that by these disclosures, the Ryan Patent
`
`anticipates claim 7.
`
`72. Claim 8 depends from claim 2 and requires that “a first additional
`
`segment is axially parallel to, but non-common co-axial with, said stent
`
`segment.” As described above with respect to claim 3, in Figure 12 of the Ryan
`
`Patent, the additional leg segments 10 of the bifurcated device are axially
`
`aligned with the body segment 20. Those leg segments 10 are axially parallel
`
`to, but non-common co-axial with, the body stent segment 20. Therefore, it is
`
`my opinion that by these disclosures, the Ryan Patent anticipates claim 8.
`
`73. Claim 9 depends from claim 8 and requires that “a second
`
`additional segment axially parallel to said stent segment, but non-co-axial with
`
`either said stent segment or said first additional stent segment.” As described
`
`above with respect to claims 3 and 8, in Figure 12 of the Ryan Patent, the
`
`additional leg segments 10 of the bifurcated device are axially parallel to the
`
`
`
`21
`
`
`
`body segment 20. Those leg segments 10 are axially parallel to, but non-
`
`common co-axial with, the body stent segment 20. Ex. 1004 at Fig. 12.
`
`74. Additionally, the two leg segments 10, 10 are non-co-axial with
`
`each other. Thus if the leg segment 10 in LI of Figure 12 is the first additional
`
`stent segment and the leg segment 10 in RI of Figure 12 is the second additional
`
`stent segment, the “second additional segment axially parallel to said stent
`
`segment, but non-co-axial with either said stent segment or said first additional
`
`stent segment.” Ex. 1004 at Fig. 12. Therefore, it is my opinion that by these
`
`disclosures, the Ryan Patent anticipates claim 9.
`
`75. Claim 12 depends from claim 2 and requires that “at least one of
`
`said additional stent segments comprises:
`
`a plurality of hoops aligned along a common axis,
`
`each of said hoops oriented in a plane substantially perpendicular to the
`
`longitudinal axis of the additional stent segment,
`
`and each of said hoops including a plurality of elongate elements joined
`
`to one another and forming apices that point in a direction along
`
`the longitudinal axis of the additional stent segment; and
`
`means for securing an apex of one hoop to a juxtaposed apex of a
`
`neighboring hoop.”
`
`As discussed above with respect to claims 2-5 and as shown in the discussion of
`
`claim 5, the Ryan Patent’s additional stent segments with “different elastic or
`
`
`
`22
`
`
`
`other mechanical properties,” may be constructed in the same way as the main
`
`stent segment such that they meet the additional limitations of claim 12 for the
`
`same reasons the stent limitations claimed in claim 1 are disclosed by the Ryan
`
`Patent. The additional limitations of claim 12 mirror the limitations of claim 1.
`
`Therefore, it is my opinion that by these disclosures, the Ryan Patent anticipates
`
`claim 12.
`
`76. Claim 13 depends from claim 1 and requires that “said hoops are
`
`formed of a single continuous wire.” The Ryan Patent depicts a stent with
`
`hoops are formed of a single continuous wire. Specifically, the Ryan Patent
`
`discloses that its hoops (band members 11) “comprise a zig-zag or Z-shaped
`
`element which forms a continuous circular ring.” Ex. 1004 at 7:49-52, Fig. 1-3.
`
`That continuous circular ring is depicted as a single zig-zaging wire in Figures
`
`1-3. Therefore, it is my opinion that by these disclosures, the Ryan Patent
`
`anticipates claim 13.
`
`77. Claim 21 depends from claim 1 and requires
`
`that “each
`
`longitudinal end of the stent is substantially perpendicular square to the
`
`longitudinal axis of the stent.” The Ryan Patent depicts and describes that
`
`“each longitudinal end of the stent is substantially perpendicular square to the
`
`longitudinal axis of the stent.” See, e.g., Ex. 1004 at Figure 2. Therefore, it is
`
`my opinion that by these disclosures, the Ryan Patent anticipates claim 21.
`
`78. Claim 22 depends from claim 1 and requires that “said stent is at
`
`
`
`23
`
`
`
`least partially covered in fabric.” The Ryan Patent discloses that its stent is at
`
`least partially covered by outer liner 110 in Figure 1A. Ex. 1004 at 8:47-9:5,
`
`Fig. 1A. Outer liner 110 is a fabric. Ex. 1004 at 8:64-66. Therefore, it is my
`
`opinion that by these disc
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