UNITED STATES PATENT AND TRADEMARK OFFICE
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________
`
`STRYKER CORPORATION,
`Petitioner,
`
`v.
`
`ORTHOPHOENIX, LLC,
`Patent Owner
`_________
`
`Case IPR2014-01535
`Patent 6,280,456 B1
`
`SECOND DECLARATION OF NEIL J. SHEEHAN
`
`
`
`
`
`
`
`STRYKER EXHIBIT 1041, pg. i
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`STRYKER CORPORATION v. ORTHOPHOENIX, LLC
`
`IPR2014-01535
`
`
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________
`
`STRYKER CORPORATION,
`Petitioner,
`
`v.
`
`ORTHOPHOENIX, LLC,
`Patent Owner
`_________
`
`Case IPR2014-01535
`Patent 6,280,456 B1
`
`SECOND DECLARATION OF NEIL J. SHEEHAN
`
`
`
`
`
`
`
`STRYKER EXHIBIT 1041, pg. i
`
`STRYKER CORPORATION v. ORTHOPHOENIX, LLC
`
`IPR2014-01535
`
`
`
`Second Declaration of Neil J. Sheehan
`
`I, Neil J. Sheehan, declare as follows:
`
`1.
`
`I previously provided a declaration for the above-captioned inter
`
`partes review (IPR), entitled Declaration of Neil J. Sheehan (Stryker Exhibit 1002,
`
`“First Declaration”), relating to U.S. Patent No. 6,280,456 (“‘456 patent”). As I
`
`stated in my First Declaration, I have been retained as an expert by Stryker
`
`Corporation (“Stryker”) for that IPR. My background and qualifications remain
`
`the same as those set forth in my First Declaration.
`
`2.
`
`I have reviewed the Board’s Decision instituting the IPR for the ‘456
`
`patent, the Patent Owner’s Response to Stryker’s Petition, and the Declaration of
`
`Gamal Baroud, Ph.D., relating to the ‘456 patent. I also reviewed the exhibits
`
`submitted by Orthophoenix and referenced by Dr. Baroud in this IPR as well as Dr.
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`Baroud’s deposition dated July 30 and 31, 2015 and accompanying exhibits.
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`While I disagree with many of the statements made by Dr. Baroud in his
`
`declaration, I respond to only certain issues below.
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`3. While I have already opined that Reiley (Ex. 1004) discloses balloon
`
`catheters that can compact cancellous bone and form a cavity (Ex. 1002 ¶ 70-72,
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`88-90), I disagree with Dr. Baroud’s conclusion that the Valley balloon catheter is
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`“insufficient to compress cancellous bone effectively.” The opposite is true. First,
`
`I note that compression of cancellous bone is not mentioned in most of the claims
`
`but is only claimed in dependent Claims 2 and 3 and there is nothing in those
`
` - 1 -
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`STRYKER EXHIBIT 1041, pg. 1
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`IPR2014-01535
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`Second Declaration of Neil J. Sheehan
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`claims about the “effectiveness” level of the compression. Nonetheless, the ‘456
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`patent discloses “materials including vinyl, nylon, polyethylenes, ionomer,
`
`polyurethane, and polyethylene tetraphthalate (PET) . . . The thickness of the
`
`structure is typically in the range of 2/1000ths to 25/1000ths of an inch, or other
`
`thicknesses that can withstand pressures of up to, for example, 250-500 psi.” (Ex.
`
`1001, 12:66-13:4.) These materials, thicknesses and pressures are applicable to all
`
`the embodiments in the ‘456 patent including both vasculature and bone. (Ex.
`
`1001, 12:64-66; 4:27-36.) Valley discloses materials and balloon wall thicknesses
`
`that are within the range of materials and balloon wall thicknesses that the ‘456
`
`patent describes for the balloon catheter of the claimed invention. As I previously
`
`explained, “Valley also discloses ‘an inflatable balloon made of nondistensible
`
`balloon material, such as polyethylene, polyethylene terephthalate polyester,
`
`polyester copolymers, polyamide or polyamide copolymers.’”1 (First Declaration,
`
`¶87.) Valley also discloses a balloon wall thickness of 0.090 to 0.130 mm (Ex.
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`1007 at 21:64-65) which is commensurate with the 2/1000ths to 25/1000ths of an
`
`1 In paragraph 23 of his declaration Dr. Baroud appears to criticize the Valley
`
`balloon for being formed of elastomeric materials. However, nothing in the claims
`
`requires that the balloon be made of either elastomeric or non-elastomeric
`
`materials. Regardless, Valley discloses nondistensible materials, which as the
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`name implies are the opposite of elastic, in addition to elastomeric materials.
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` - 2 -
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`STRYKER EXHIBIT 1041, pg. 2
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`IPR2014-01535
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`Second Declaration of Neil J. Sheehan
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`inch [0.051 to 0.635 mm] disclosed in the ‘456 patent. I therefore confirm my
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`prior opinion that the Valley balloons are “commensurate with balloons that can
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`compress cancellous bone as disclosed in the 456 patent.” (First Declaration, ¶87.)
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`4.
`
`Dr. Baroud states that “the balloon described in the ’456 patent is
`
`designed to withstand pressures up to 250–500 psi. Ex. 1001 at 13:1-5. In my
`
`experience, such pressures are routinely used to compress cancellous bone.” (Ex.
`
`2018 ¶19.) I note, however, that the ‘456 patent does not indicate that 250-500 psi
`
`is required to compress cancellous bone. On the contrary, 250-500 psi is merely an
`
`exemplary pressure range and pressures well under 250 psi can compress
`
`cancellous bone. (Ex. 1001 at 13:2-4.) Compression of cancellous bone and the
`
`formation of a cavity can occur at pressures far below 250 psi. For example, an
`
`article entitled “Initial Outcome and Efficacy of ‘Kyphoplasty’ in the Treatment of
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`Painful Osteoporotic Vertebral Compression Fractures” by Lieberman, which I
`
`understand has been relied upon by Orthophoenix (Ex. 2008), discloses
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`compression of cancellous bone and creation of a cavity during balloon-assisted
`
`vertebroplasty at pressures as low as 70 psi. (Ex. 1030 p. 3-4.) Likewise, U.S.
`
`Patent No. 5,108,404, which I discussed in my First Declaration at paragraph 27,
`
`discloses performing balloon-assisted vertebroplasty and forming an initial cavity
`
`in cancellous bone by inflating a balloon to a pressure as low as 50 psi. (Ex. 1010
`
`6:63.) Additionally, Dr. Baroud’s own reference, Ex. 2020, discloses that
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` - 3 -
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`STRYKER EXHIBIT 1041, pg. 3
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`IPR2014-01535
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`Second Declaration of Neil J. Sheehan
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`pressures necessary to compress proximal femur cancellous bone to total failure,
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`i.e., the ultimate strength, can be as low as 0.3 MPa, which is approximately 43 psi.
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`(Ex. 2020.) I note that this is also consistent with Dr. Baroud’s deposition
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`testimony that pressures under 250 psi are capable of compressing cancellous
`
`bone.
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`5.
`
`In paragraph 22 of his declaration, Dr. Baroud performed a calculation
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`alleging to represent the circumferential stress within the wall of “the” Valley
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`balloon. The calculation involved the following equation, which is the equation
`
`for the circumferential stress on a cylindrical thin-walled pressure vessel:
`
`
`
`𝝈 = 𝐩 ∙𝐫𝐭
`
`where σ is the circumferential stress, p is the internal pressure, r is the radius and t
`
`is the thickness. Dr. Baroud performed his calculations using pressure ranges (p)
`
`of 250 to 500 psi using dimensions disclosed in Valley (r = 17.5 mm, t = 0.13
`
`mm). Dr. Baroud then compared the results of his calculations to the “Typical
`
`strength” presented in the table in paragraph 22 of his declaration to determine if
`
`the calculated circumferential stress was within the range of the “Typical strength”
`
`of materials disclosed in Valley. Dr. Baroud relied on endura.com and plastic-
`
`products.com to identify the “Typical strengths” that he presented (Ex. 1033). Dr.
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` - 4 -
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`STRYKER EXHIBIT 1041, pg. 4
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`IPR2014-01535
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`Second Declaration of Neil J. Sheehan
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`Baroud’s table indicated that the materials disclosed in Valley could withstand
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`stress up to 33,000 psi with polyurethane being able to withstand the highest.2
`
`6.
`
`Dr. Baroud performed the same calculations to determine the
`
`circumferential stresses that would result on the Valley balloon at pressures of 35,
`
`70, 140 and 225 psi. (Ex. 1034, calculations 3, 4, 5, and 6.) These calculations
`
`have been reproduced below.
`
`
`2 I note that Dr. Baroud admitted in his deposition that the table presented in
`
`paragraph 22 of his declaration incorrectly represented the strength of PET as
`
`6,000-13,000 psi. The reference Dr. Baroud relied upon, the Endura website,
`
`indicated the strength of PET was 7,000 to 23,000 psi. (Ex. 1033; Orthophoenix
`
`Ex. 2018, remarked as Stryker Exhibit 1035, p. 17.)
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` - 5 -
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`STRYKER EXHIBIT 1041, pg. 5
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`IPR2014-01535
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`Second Declaration of Neil J. Sheehan
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`
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`(Ex. 1034.) The results of these calculations (3 through 6) show that the
`
`
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`circumferential stresses were within the range of “Typical strengths” of at least
`
`one, and sometimes more than one of the listed Valley materials in paragraph 22 of
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` - 6 -
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`STRYKER EXHIBIT 1041, pg. 6
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`IPR2014-01535
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`Second Declaration of Neil J. Sheehan
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`Dr. Baroud’s declaration. Therefore, Dr. Baroud’s calculations in Exhibit 1034
`
`prove that the Valley balloon can withstand pressures of 70 to 225 psi without
`
`bursting, which are pressures that, as discussed above, can compress cancellous
`
`bone and form a cavity.
`
`7.
`
`Dr. Baroud further calculated that minor modifications to the Valley
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`balloons, such as increasing the wall thickness by only 0.01 mm from 0.13 mm to
`
`0.14 mm (calculation 1) or decreasing the diameter of the balloon by only 1.0 mm
`
`from 35 mm to 34 mm (calculation 2), would result in a balloon that would not
`
`rupture at 250 psi. Making such minor modifications to a balloon catheter were
`
`routine at the time of the invention when designing balloons and balloon catheters
`
`and would have been well within the knowledge of a person of ordinary skill in the
`
`art. Indeed, larger modifications were also routine and well-known.
`
`8.
`
`I disagree with Dr. Baroud’s opinion in paragraph 22 that “at the
`
`pressure specified in the ‘505 [sic, ‘456] patent, 250-500 psi, the balloon in Valley
`
`will most likely rupture or be punctured….” Although such pressures are not
`
`required to compress cancellous bone or form a cavity as discussed above, balloons
`
`such as those described in Valley can operate at pressures that exceed 250 psi. As
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`I mentioned, the calculation that Dr. Baroud utilizes in paragraph 22 of his
`
`declaration is for cylindrical thin-walled pressure vessels. This equation does not
`
`account for spherical balloons, which are also disclosed in Valley. (Ex. 1006 at
`
` - 7 -
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`STRYKER EXHIBIT 1041, pg. 7
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`IPR2014-01535
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`Second Declaration of Neil J. Sheehan
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`5:37-38.) For spherical thin walled pressure vessels, the equation is generally the
`
`same, except the denominator is 2t, instead of t, i.e., (Ex. 1036, 1037.)
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`𝝈 = 𝐩 ∙𝐫𝟐𝐭
`
`(Ex. 1036 at 7.) This is because spherical thin-walled pressure vessels can
`
`withstand twice the stress of cylindrical thin-walled pressure vessels (of the same
`
`radius and wall thickness). Dr. Baroud acknowledged that a spherical balloon
`
`having the same dimensions and thicknesses as was disclosed in Valley would be
`
`capable of withstanding pressures of 250 psi. Dr. Baroud’s calculation of the
`
`circumferential stress for a spherical Valley balloon at 250 psi are reproduced
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`below:
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`(Ex. 1037.) The resulting circumferential stress is half the lower circumferential
`
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` - 8 -
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`STRYKER EXHIBIT 1041, pg. 8
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`IPR2014-01535
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`Second Declaration of Neil J. Sheehan
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`stress initially calculated by Dr. Baroud in paragraph 22 and is within the range of
`
`at least three materials disclosed by Valley: polyurethane, PET (with the correct
`
`value of 7,000-23,000 psi) and nylon (polyamide). Therefore, Dr. Baroud’s
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`calculation in Exhibit 1037 again proves that the Valley balloon can withstand
`
`pressures greater than 250 psi, although such pressures are not necessary to
`
`compress cancellous bone and form a cavity.
`
`9.
`
`In paragraphs 24, 28 and 30-31 of his declaration, Dr. Baroud makes
`
`reference to the shape and size of specific embodiments in the ‘456 patent and
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`states that “the balloon of the ‘456 patent creates a cavity of predictable and
`
`uniform geometry. . .” and “the ‘456 patent is designed to create a cavity which
`
`allows for compaction of the cancellous bone that is relatively uniform . . .” outside
`
`the context of any specific claims or claim language. Dr. Baroud offers no
`
`particular opinion on claim construction but to the extent that it is implied that
`
`these limitations are required by the claims, I disagree. Claims 2 and 3 are the only
`
`claims at issue that mention compaction of cancellous bone or creation of a cavity.
`
`Nothing in Claims 2 or 3 requires a specific amount of compression of cancellous
`
`bone or formation of a cavity, let alone “relatively uniform and predictable”
`
`compression. Moreover, the ‘456 patent specifically discloses asymmetric
`
`balloons which, perforce, would result in non-uniform compression. (See e.g., Ex.
`
`1001 at Figs. 11A-B, 14A-B; 7:58-65.) In any event, even if a uniform and
`
` - 9 -
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`STRYKER EXHIBIT 1041, pg. 9
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`IPR2014-01535
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`Second Declaration of Neil J. Sheehan
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`predictable compression of cancellous bone were required, Reiley and Valley
`
`would necessarily disclose such compression and formation of a cavity. That is
`
`because, as discussed above, Valley discloses balloons made of the same materials,
`
`using the same thicknesses, and exhibiting the same properties as the ‘456 patent
`
`balloons. (See also First Declaration at ¶87; Ex. 1001 12:64-13:4.) Moreover,
`
`Reiley explicitly discloses that its balloon can compress cancellous bone and
`
`“provide[s] for optimum compression of all the bone marrow” and also discloses
`
`the use of similar materials and thicknesses for the balloon. (Id., Ex. 1004 at 6:31-
`
`35, Abstract, 10:6-9 (“The material of the balloon is preferably a non-elastic
`
`material, such as polyethylene tetraphthalate (PET)”), 10:15-18 (thickness of
`
`2/1000ths to 25/1000ths of an inch).)
`
`10.
`
`In paragraphs 19 and 20 of his declaration, Dr. Baroud makes a
`
`number of statements regarding peak inflation pressure, interior static pressure, and
`
`dynamic pressure. None of these statements are relevant to whether the
`
`combination of Reiley and Valley render the claims obvious. The ‘456 patent
`
`claims do not specify any type of pressure limitation. Furthermore, whether a
`
`disclosed pressure is the peak inflation pressure, the interior static pressure or the
`
`dynamic pressure is of no consequence if it is a pressure that the subject balloon is
`
`capable of withstanding. A balloon catheter is a closed system and will experience
`
`the same pressure throughout when the balloon is inflated. (Ex. 2017 at 66:3-8,
`
` - 10 -
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`STRYKER EXHIBIT 1041, pg. 10
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`IPR2014-01535
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`Second Declaration of Neil J. Sheehan
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`89:8-90:5.) I also note that Dr. Baroud ultimately offered a similar opinion during
`
`his deposition. (Ex. 1040 at 76:13-24.)
`
`11.
`
`In paragraph 28 of his declaration, Dr. Baroud states that “Reiley (Ex.
`
`1004) does teach against using prior art balloon catheter designs for bone.
`
`Specifically, Reiley states that the prior art: does not teach the shape of the
`
`balloon. . . .” The language quoted by Dr. Baroud relates to the design of the
`
`balloon and not to the “coaxial catheter with inner and outer tubing,” which Reiley
`
`praised as a “particular improvement” in the prior art. (First Declaration ¶72.)
`
`Moreover, Dr. Baroud ignores the fact that Reiley endeavors to improve that
`
`purported deficiency by itself teaching a balloon of suitable size and shape for
`
`bone. (First Declaration ¶27, 71; Ex. 1004 at 7:20-28.) In the “Summary of the
`
`Invention,” Reiley teaches that its improved balloons provide for “optimum” use in
`
`bone. (Id. at 6:31-35.) Thus, as I stated in paragraph 88-89 of my First
`
`Declaration “a person of ordinary skill in the art would understand that Reiley
`
`provides the specific reason, basis, or motivation to combine Reiley with Valley
`
`because Valley has a balloon catheter very similar to Andersen, namely a balloon
`
`catheter with the claimed inner and outer tubing arrangement.” Thus, Reiley
`
`teaches toward the suggested combination, not against it.
`
`12.
`
`In paragraph 32 of his declaration, Dr. Baroud states that “Reiley does
`
`teach not to use the balloon structures seen in the prior art. Nor does the prior art,
`
` - 11 -
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`STRYKER EXHIBIT 1041, pg. 11
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`IPR2014-01535
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`Second Declaration of Neil J. Sheehan
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`at least according to Reiley, provide any guidance on how to design an appropriate
`
`balloon for bone.” In addition to the reasons I have set forth above which
`
`contradict this statement, i.e. that Reiley praised the design of balloon catheters
`
`used in angioplasty, including the Andersen design, I also stated in my First
`
`Declaration at paragraph 72 that “Reiley also suggests that [the intravascular
`
`catheter] Andersen be consulted for balloon material choices.” (citing Ex. 1004 at
`
`10:12-14) (“The restraints [of the balloon] can be made of flexible, inelastic high
`
`tensile strength material including, but not limited, to those described in U.S.
`
`Patent 4,706,670 [Andersen].”) As I further noted in my First Declaration,
`
`paragraph 72, footnote 2, the fact that “Reiley notes that ‘generally’ balloons may
`
`not provide ‘adequate cavity formation,’ [] has no relevance to the elements of
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`Claims 1-12.” I agree with the Board’s conclusion that “we are not persuaded that
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`Reiley criticized the prior art catheters, as Patent Owner suggests. . . . Although
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`Reiley also states that such balloons are ‘too small and generally have the wrong
`
`configuration and are generally not strong enough to accomplish adequate cavity
`
`formation in either the vertebral bodies or long bones of the body,’ this generic
`
`statement does not amount to teaching away from the claimed invention.”
`
`(Decision at 10.)
`
`13.
`
`In paragraph 44 of my First Declaration, I provided my understanding
`
`that a person ordinarily skill in the art “would have a mechanical engineering
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` - 12 -
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`STRYKER EXHIBIT 1041, pg. 12
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`IPR2014-01535
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`Second Declaration of Neil J. Sheehan
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`degree, industrial design degree, or similar technical degree, or equivalent work
`
`experience, and at least 5 years of working in the area of medical device design,
`
`including experience with catheters carrying an expandable or inflatable structure,
`
`such as a typical balloon catheter.” Dr. Baroud has stated that “a person of
`
`ordinary skill in the art would have had advanced training in mechanical and
`
`biomechanical engineering and would have had specific experience with the
`
`mechanics and properties of bones as well as, more specifically, with the field of
`
`bone augmentation. Bone augmentation includes bone strengthening, increasing
`
`osseous dimensions as well as verterbroplasty [sic] and kyphoplasty.” (Ex. 2018
`
`¶14.) I disagree with Dr. Baroud’s definition of a person of ordinary skill in the
`
`art. Dr. Baroud’s definition fails to consider the entire breadth of the ‘456 patent
`
`disclosure and field of invention. The ‘456 patent broadly “relates to expandable
`
`structures, which, in use, are deployed in interior body regions of humans and
`
`other animals.” (Ex. 1001 at 1:9-11.) As the ‘456 patent explains, “interior body
`
`regions” include at least “the vasculature and interior bone.” (Id. 1:22-23.)
`
`Therefore, Dr. Baroud’s definition excludes expandable structures deployed in the
`
`vasculature and other interior body regions. Additionally, Dr. Baroud’s definition
`
`fails to address any experience with medical device design including experience
`
`related to catheters carrying an expandable or inflatable structure, which is
`
`necessary for the field of this invention. I note that Dr. Baroud has stated that he
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` - 13 -
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`STRYKER EXHIBIT 1041, pg. 13
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`IPR2014-01535
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`Second Declaration of Neil J. Sheehan
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`has no experience in design of catheters carrying an expandable or inflatable
`
`structure (balloons).
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`14.
`
`In view of the opinions set forth above and in my first declaration for
`
`this IPR, I maintain my opinion that claims 1-10 of the ‘456 patent are anticipated
`
`or obvious and are not patentable.
`
`15.
`
`I hereby declare that all statements made herein of my own
`
`knowledge are true and that all statements made on information and belief are
`
`believed to be true; and further that these statements were made with the
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`knowledge that willful false statements and the like so made are punishable by fine
`
`or imprisonment, or both, under Section 1001 of Title 18 of the United States
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`Code.
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`
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`Date:
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`Neil J. Sheehan
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` - 14 -
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`STRYKER EXHIBIT 1041, pg. 14
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`IPR2014-01535
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