UNITED STATES PATENT AND TRADEMARK OFFICE
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________
`
`STRYKER CORPORATION,
`Petitioner,
`
`v.
`
`ORTHOPHOENIX, LLC,
`Patent Owner
`_________
`
`Case IPR2014-01519
`Patent 6,623,505 B2
`
`SECOND DECLARATION OF NEIL J. SHEEHAN
`
`
`
`
`
`
`
`STRYKER EXHIBIT 1041, pg. i
`
`STRYKER CORPORATION v. ORTHOPHOENIX, LLC
`
`IPR2014-01519
`
`
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________
`
`STRYKER CORPORATION,
`Petitioner,
`
`v.
`
`ORTHOPHOENIX, LLC,
`Patent Owner
`_________
`
`Case IPR2014-01519
`Patent 6,623,505 B2
`
`SECOND DECLARATION OF NEIL J. SHEEHAN
`
`
`
`
`
`
`
`STRYKER EXHIBIT 1041, pg. i
`
`STRYKER CORPORATION v. ORTHOPHOENIX, LLC
`
`IPR2014-01519
`
`
`
`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. 6,623,505 (“‘505 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 ‘505
`
`patent, the Patent Owner’s Response to Stryker’s Petition, and the Declaration of
`
`Gamal Baroud, Ph.D., relating to the ‘505 patent. I also reviewed the exhibits
`
`submitted by Orthophoenix and referenced by Dr. Baroud in this IPR as well as Dr.
`
`Baroud’s deposition dated July 30 and 31, 2015 and accompanying exhibits.
`
`While I disagree with many of the statements made by Dr. Baroud in his
`
`declaration, I respond to only certain issues below.
`
`3.
`
` In Paragraph 35 of my First Declaration, I stated that a person of skill
`
`in the art would understand that the elements set forth in the claim bodies describe
`
`structurally complete inventions such that deletion of the preambles would not
`
`affect the structure of the claimed inventions. Similarly, I stated that a person of
`
`skill in the art would understand that the preambles in the claims of the ‘505 patent
`
`merely state the purpose or intended use of the claims. In Paragraph 22 of his
`
` - 1 -
`
`STRYKER EXHIBIT 1041, pg. 1
`
`
`
`Second Declaration of Neil J. Sheehan
`
`declaration, Dr. Baroud states that “[t]he term ‘bone’ in the preamble and/or body
`
`of the claims requires that the claimed device possess structure and properties
`
`compatible with, i.e., designed and constructed for use in bone.” I disagree with
`
`Dr. Baroud’s statements to the extent that he contends that the preamble should be
`
`limiting. In line with my prior opinion, I agree with the conclusion of the PTAB in
`
`its Institution Decision: “the body of each of claims 1, 5, and 9 fully and
`
`intrinsically sets forth all of the limitations of the claim, and [] the preamble is not
`
`a limitation.” (Decision at 8.)
`
`4.
`
`Additionally, Br. Baroud seems to imply that the use of the word bone
`
`in the claim elements of Claims 5 and 9 (“the inflatable structure being sized and
`
`configured for passage within a cannula into bone”) supports finding the preamble
`
`of Claims 5 and 9 to be limiting. However, I agree with the Board’s conclusion in
`
`the Institution Decision (p. 7) that the term ‘bone’ in the preamble does not
`
`provides any distinct definition of the term ‘bone’ in the body of the claims. I
`
`further note that the reference to “bone” in the body of Claims 5 and 9 is not a
`
`structural limitation for the claimed devices and systems, but merely references
`
`that one of the actual structural elements in the claims (the inflatable structure) is
`
`of a size and configuration such that it is capable of passing within a cannula into
`
`bone. Because the elements of Claims 1, 5 and 9 disclose a structurally complete
`
`invention and because the preambles of Claims 1, 5 and 9 merely state a purpose or
`
` - 2 -
`
`STRYKER EXHIBIT 1041, pg. 2
`
`
`
`Second Declaration of Neil J. Sheehan
`
`intended use, I maintain my opinion that the preamble should not limit the ‘505
`
`patent claims.
`
`5.
`
`I further disagree with Dr. Baroud’s opinion in paragraph 22 of his
`
`declaration that “[w]ithout significant modification of both the mechanical and
`
`structural properties of the balloons, bone catheters outfitted with bone balloons
`
`cannot be used in blood vessels, nor can blood vessel catheters outfitted with
`
`vascular balloons be used in bone.” As I explained in my First Declaration, “with
`
`the advent of balloon-assisted vertebroplasty, or vertebral kyphoplasty, in the late
`
`1980s, it became well-known (and even the ‘505 patent specification recognizes)
`
`that balloon catheter designs originally conceived for cardiovascular purposes
`
`could be used in bone.” (¶16.) I further explained that “a person of skill in the art
`
`looking to design a balloon catheter for bone applications would consider
`
`angioplasty and other cardiovascular catheters.” I gave examples of how balloon
`
`catheters were used across applications. (¶24.) I also explained that the Reiley
`
`reference, which disclosed “[a] balloon (10) for use in compressing cancellous
`
`bone . . .”, “praised the design of balloon catheters used in angioplasty, including
`
`the Andersen design . . .” and stated that “current medical balloons can compress
`
`bone. . .” (¶18.) I also explained that “[t]he ‘505 patent does not distinguish
`
`between an inflatable structure adapted and configured to compress cancellous
`
`bone and one adapted and configured for compression of plaque in arteries.” (¶82;
`
` - 3 -
`
`STRYKER EXHIBIT 1041, pg. 3
`
`
`
`Second Declaration of Neil J. Sheehan
`
`see e.g., Ex. 1001 at 1:25-27, 4:23-40, 4:41-11:49 (deployment in bone), 11:50-
`
`12:25 (deployment in the vasculature), 12:64-13:4 (material selection irrespective
`
`of use.))
`
`6.
`
`In further contradiction to Dr. Baroud’s opinion that “[w]ithout
`
`significant modification of both the mechanical and structural properties of the
`
`balloons, bone catheters outfitted with bone balloons cannot be used in blood
`
`vessels, nor can blood vessel catheters outfitted with vascular balloons be used in
`
`bone,” I identified several prior art references relating to a balloon catheter for use
`
`in the vasculature that have materials and properties consistent with those disclosed
`
`in the ‘505 patent. The ‘505 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 ‘505 patent including both vasculature
`
`and bone. (Ex. 1001, 12:64-66; 4:27-36.) I identified that the Levy patent
`
`“discloses a balloon with a burst pressure of, for example, between 200 and 500
`
`psi, which is commensurate with the range disclosed by the ‘505 patent.” (First
`
`Declaration, ¶65.) I also explained that Andersen “indicates that its balloon
`
`portion may be formed from polyurethane” and “that the inflatable structure is
`
` - 4 -
`
`STRYKER EXHIBIT 1041, pg. 4
`
`
`
`Second Declaration of Neil J. Sheehan
`
`capable of operation ‘at pressures of up to 20 atmospheres,’ which is
`
`approximately 294 psi, which is commensurate with the range of the ‘505 patent.”
`
`(First Declaration, ¶ 108.) I have also explained that “Valley discloses ‘an
`
`inflatable balloon made of nondistensible balloon material, such as polyethylene,
`
`polyethylene
`
`terephthalate polyester, polyester copolymers, polyamide or
`
`polyamide copolymers.’”1 (First Declaration, ¶¶ 82-83.) Valley also discloses a
`
`balloon wall thickness of 0.090 to 0.130 mm (Ex. 1007 at 21:64-65) which is
`
`commensurate with the 2/1000ths to 25/1000ths of an inch [0.051 to 0.635 mm]
`
`disclosed in the ‘505 patent. Therefore, I disagree that significant modifications
`
`would be required for a bone catheter outfitted with bone balloons to be used in
`
`blood vessels or for a blood vessel catheter outfitted with vascular balloons to be
`
`used in bone.
`
`7.
`
`As I stated in paragraph 36 of my First Declaration, “‘adapted and
`
`configured to compress cancellous bone upon inflation . . .’ means that the
`
`inflatable structure is of an adaptation and configuration such that it is capable of
`
`1 In paragraph 27 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. In any event, Valley discloses nondistensible materials, which as the
`
`name implies are the opposite of elastic, in addition to elastomeric materials.
`
` - 5 -
`
`STRYKER EXHIBIT 1041, pg. 5
`
`
`
`Second Declaration of Neil J. Sheehan
`
`compressing cancellous bone upon inflation.” I agree with the Board, which
`
`concluded that “Valley’s balloons are inherently capable of compressing
`
`cancellous bone.” (Decision at 12.) As I stated in paragraph 83 of my First
`
`Declaration, “just as the inflatable structures of the ‘505 patent are adapted and
`
`configured to compress cancellous bone, Valley discloses balloons that are also
`
`adapted and configured to compress cancellous bone upon inflation of the
`
`inflatable structure in bone.” However, in paragraph 23 of his declaration, Dr.
`
`Baroud states that “[t]he dilatation balloons in Valley (Ex. 1007) are not
`
`‘inherently capable of compressing cancellous bone.’” I disagree with Dr. Baroud
`
`and maintain my initial opinion that Valley discloses all the limitations of the ‘505
`
`patent claims and discloses balloon catheters of an adaptation and configuration
`
`capable of compressing cancellous bone upon inflation.
`
`8.
`
`Dr. Baroud states that “the balloon described in the ’505 patent is
`
`designed to withstand pressures up to 250–500 psi.” (Ex. 2018 ¶23.) The ‘505
`
`patent, however, 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 for the balloons catheters of the ‘505 patent, which can be used in both bone
`
`or the vasculature. (Ex. 1001 at 13:2-4.) As discussed above, Valley discloses
`
`materials and balloon wall thicknesses that are within the range of materials and
`
`balloon wall thicknesses that the ‘505 patent describes as typical for the inflatable
`
` - 6 -
`
`STRYKER EXHIBIT 1041, pg. 6
`
`
`
`Second Declaration of Neil J. Sheehan
`
`structure including inflatable structures adapted and configured to compress
`
`cancellous bone.
`
`9.
`
`Consistent with my prior opinions, compression of cancellous bone
`
`can occur at pressures far below 250 psi. For example, an article entitled “Initial
`
`Outcome and Efficacy of ‘Kyphoplasty’ in the Treatment of Painful Osteoporotic
`
`Vertebral Compression Fractures” by Lieberman, which I understand has been
`
`relied upon by Orthophoenix (Ex. 2008), discloses compression of cancellous bone
`
`and creation of a cavity during balloon-assisted vertebroplasty at pressures as low
`
`as 70 psi. (Ex. 1030 pp. 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 pressures necessary to compress
`
`proximal femur cancellous bone to total failure, i.e., the ultimate strength, can be
`
`as low as 0.3 MPa, which is approximately 43 psi. (Ex. 2020.) I note that this is
`
`also consistent with Dr. Baroud’s testimony that pressures under 250 psi are
`
`capable of compressing cancellous bone. Therefore, I disagree with any opinions
`
`of Dr. Baroud that are premised on the notion that 250-500 psi is required to
`
`compress cancellous bone.
`
`10.
`
`In paragraph 26 of his declaration, Dr. Baroud performed a calculation
`
` - 7 -
`
`STRYKER EXHIBIT 1041, pg. 7
`
`
`
`Second Declaration of Neil J. Sheehan
`
`alleging to represent the circumferential stress within the wall of “the” Valley
`
`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 26 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.
`
`Baroud’s table indicated that the materials disclosed in Valley could withstand
`
`stress up to 33,000 psi with polyurethane being able to withstand the highest. 2
`
`
`2 I note that Dr. Baroud admitted in his deposition that the table presented in
`
`paragraph 26 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.)
`
` - 8 -
`
`STRYKER EXHIBIT 1041, pg. 8
`
`
`
`Second Declaration of Neil J. Sheehan
`
`
`11. 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.
`
` - 9 -
`
`STRYKER EXHIBIT 1041, pg. 9
`
`
`
`Second Declaration of Neil J. Sheehan
`
`
`
`(Ex. 1034.) The results of these calculations show that the circumferential stresses
`
`
`
`were within the range of “Typical strengths” of at least one, and sometimes more
`
` - 10 -
`
`STRYKER EXHIBIT 1041, pg. 10
`
`
`
`Second Declaration of Neil J. Sheehan
`
`than one, of the listed Valley materials in paragraph 26 of Dr. Baroud’s
`
`declaration. Therefore, Dr. Baroud’s calculations in Exhibit 1034 prove that the
`
`Valley balloon can withstand pressures of 70-225 psi, which are pressures that can
`
`compress cancellous bone as discussed above.
`
`12. Dr. Baroud further calculated that minor modifications to the Valley
`
`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.
`
`13.
`
`I disagree with Dr. Baroud’s opinion in paragraph 26 that “at the
`
`pressure specified in the ‘505 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 I
`
`mentioned, the calculation that Dr. Baroud utilizes in paragraph 26 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. 1007 at
`
` - 11 -
`
`STRYKER EXHIBIT 1041, pg. 11
`
`
`
`Second Declaration of Neil J. Sheehan
`
`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.,
`
`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
`
`below:
`
`(Ex. 1037.) The resulting circumferential stress is half the lower circumferential
`
`stress initially calculated by Dr. Baroud in paragraph 26 and is within the range of
`
`
`
` - 12 -
`
`STRYKER EXHIBIT 1041, pg. 12
`
`
`
`Second Declaration of Neil J. Sheehan
`
`at least three materials disclosed in Valley: polyurethane, PET (with the corrected
`
`value of 7,000-23,000 psi) and nylon (polyamide). Therefore, Dr. Baroud’s
`
`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.
`
`14. Dr. Baroud states that “‘adapted and configured to compress
`
`cancellous bone upon inflation of the inflatable structure in bone’ means that the
`
`inflatable structure is designed and constructed to compress cancellous bone. It is
`
`clear that the inflatable structure must be designed and constructed to compress
`
`cancellous bone upon inflation in a manner that creates a relatively uniform and
`
`predictable compression in the cancellous bone (see discussion of Figures 17-20
`
`below).” (¶ 21.) I disagree with Dr. Baroud’s interpretation of “adapted and
`
`configured to compress cancellous bone upon inflation of the inflatable structure in
`
`bone” as recited in Claims 3, 7 and 11. Nothing in Claims 3, 7 or 11 requires a
`
`specific type of compression of cancellous bone, let alone “relatively uniform and
`
`predictable” compression. Moreover, the specification specifically discloses
`
`asymmetric balloons which, perforce, would result in non-uniform compression of
`
`cancellous bone. (See e.g., Ex. 1001 at Figs. 11A-B, 14A-B, 7:58-64.) In any
`
`event, even if a uniform and predictable compression of cancellous bone were
`
`required, Valley would necessarily disclose such compression because Valley
`
` - 13 -
`
`STRYKER EXHIBIT 1041, pg. 13
`
`
`
`Second Declaration of Neil J. Sheehan
`
`discloses balloons made of the same materials, using the same thicknesses and
`
`exhibiting the same properties as the ‘505 patent balloons. (First Declaration at
`
`¶83.)
`
`15. Later in his declaration (paragraphs 28-31 and 37-41) Dr. Baroud
`
`addresses uniform and predictable compaction of cancellous bone outside the
`
`context of any specific claims or claim language, but at one point actually
`
`references Reiley. Again, for the reasons set forth above, I disagree that any of the
`
`claims or claim elements, particularly Claims 3, 7 and 11, should be limited by
`
`requiring uniform and predictable compression of cancellous bone. Even if a
`
`uniform compression of cancellous bone were required by the ‘505 patent, 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. 1006 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).)
`
`16.
`
`In paragraph 18 (and others), Dr. Baroud also refers to embodiments
`
`(Figures 17, 18 and 20) of the ‘505 patent with inverted ends, implying that
`
`inversion of the inflatable structure is also required by Claims 7 and 11. Nothing
`
`in Claims 7 or 11 (or any of Claims 1-12 for that matter) require inversion of the
`
` - 14 -
`
`STRYKER EXHIBIT 1041, pg. 14
`
`
`
`Second Declaration of Neil J. Sheehan
`
`inflatable structure. Nonetheless, as I explained in my declaration submitted in
`
`IPR2014-01535 (Ex. 1002 at ¶86, 90), Valley also describes balloons with inverted
`
`ends. (See e.g., Ex. 1007 at Figs. 8A-C; 25:8-42.)
`
`17.
`
`In paragraphs 23 and 24 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 Valley meets
`
`all the elements of the ‘505 patent claims. The ‘505 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, 89:8-90:5.) I also
`
`note that Dr. Baroud ultimately offered a similar opinion during his deposition.
`
`(Ex. 1040 at 76:13-24.)
`
`18.
`
` As I explained in my First Declaration (¶¶ 102-108), the Andersen
`
`reference (Exhibit 1005) discloses each and every element of claims 1, 3-5, 7-9 and
`
`11-12 of the ‘505 patent and it would be obvious to combine Andersen with the
`
`Reiley reference (Ex. 1006) to render obvious each claim 1-12 of the ‘505 patent. I
`
`understand that Dr. Baroud asserts that Andersen does not disclose the element
`
`“the inflatable structure extending outside and beyond the outer catheter tube.”
`
` - 15 -
`
`STRYKER EXHIBIT 1041, pg. 15
`
`
`
`Second Declaration of Neil J. Sheehan
`
`(Ex. 2018 at ¶36.) According to Dr. Baroud, the portion that I have identified as
`
`the balloon portion anchored to the inner catheter tube (circled in orange in the
`
`Figure below) should be identified as part of the outer catheter tube. (See e.g., Id.
`
`at ¶34.) I have reviewed and considered the opinions of Dr. Baroud and I
`
`respectfully disagree. My opinion remains the same as I set forth in my First
`
`Declaration: Andersen (Ex. 1002) discloses an inflatable structure extending
`
`outside and beyond the outer catheter tube.
`
`19.
`
`I have reproduced below the figure that I included in paragraph 105 of
`
`my First Declaration depicting the outer catheter tube colored red, the inner
`
`catheter tube colored green, and the inflatable structure colored blue. The disputed
`
`area is circled in orange.
`
`20. Contrary to Dr. Baroud’s statements, the blue portion circled in
`
`orange is recognized by the Andersen reference itself as part of the balloon portion
`
`
`
` - 16 -
`
`STRYKER EXHIBIT 1041, pg. 16
`
`
`
`Second Declaration of Neil J. Sheehan
`
`of the device and not the outer catheter tubing. For example, as I explained in my
`
`First Declaration (Ex. 1002 at ¶ 105, 108), Andersen specifically teaches that the
`
`balloon portion is formed at the distal end of the outer tubing and that it is
`
`anchored to the inner tube:
`
`An inflatable balloon portion is formed at the distal end of the outer
`
`tubing and is anchored to the distal end of the inner tubing.
`
`(Ex. 1005 at 2:19-23.) In other words, the circled portion is the portion of the
`
`Andersen balloon that allows for bonding or attachment to the inner catheter tube,
`
`which as I discuss below, is necessary and typical for balloon catheters.
`
`21. This fact is further confirmed by other portions of the Andersen
`
`specification. Andersen further describes that the “[n]eck 26 on distal tip 22 is
`
`sealed to the distal end of the balloon portion I of the shaft,” which clearly
`
`indicates that the blue portion circled in orange is part of the balloon portion (not
`
`the outer tubing). (Ex. 1005 at 5:33-34.) Specifically, the neck provides a way to
`
`seal the balloon to the inner catheter tube. The neck of the distal tip is highlighted
`
`in purple in the Figure below:
`
` - 17 -
`
`STRYKER EXHIBIT 1041, pg. 17
`
`
`
`Second Declaration of Neil J. Sheehan
`
`
`
`
`22. Typically, balloon catheters have a portion or portions of the balloon
`
`that are sealed or bonded to the catheter in a secure manner. These bonded/sealed
`
`regions are generally of a length significant enough to provide a sufficiently strong
`
`bond or seal during use of the catheter. This bonded region is described and shown
`
`in the Andersen reference as I addressed above.
`
`23. The ‘505 patent itself also recognizes that there must be a portion of
`
`the inflatable structure that attaches to the catheter tube. The ‘505 patent calls it
`
`the “bonded region,” and is shown in Figure 19 (reproduced below with
`
`annotations) of the patent at 116. (Ex. 1001, 10:38-39.) Referring to Figure 19,
`
`the patent states that the inflatable structure “can then be directly exposed to
`
`conventional adhesive or melt bonding processes, to form the bonded regions.”
`
`(Id.)
`
`24. During his deposition, Dr. Baroud was asked to highlight in blue the
`
` - 18 -
`
`STRYKER EXHIBIT 1041, pg. 18
`
`
`
`Second Declaration of Neil J. Sheehan
`
`balloon portion of Figure 19 of the ‘505 patent (Ex. 1040, Baroud Dep. Tr. 37:3 –
`
`38:9) and he highlighted the bonded regions of the balloon – just as I did for the
`
`Andersen reference. The relevant area is circled in orange below.
`
`
`
`(See Ex. 1031 (blue coloring added by Dr. Baroud) (orange circle added).) Thus,
`
`Dr. Baroud recognizes that the portion of the inflatable structure that attaches the
`
`inflatable structure to a catheter tube is part of the inflatable structure and he
`
`colored an inflatable structure in the same way that I did, i.e., including the portion
`
`where it is attached to the inner tube.
`
`25. Even if one were to take the view that Andersen does not disclose an
`
`inflatable structure extending outside and beyond the outer catheter tube, Reiley
`
`discloses balloon catheters where the “inflatable structure extend[s] outside and
`
`beyond the outer catheter tube.” (Ex. 1006, Figs. 1-4, 6, 8, 10, 12, 15.) This is a
`
`well-known and understood configuration in the balloon catheter prior art. A
`
` - 19 -
`
`STRYKER EXHIBIT 1041, pg. 19
`
`
`
`Second Declaration of Neil J. Sheehan
`
`person of ordinary skill in the art who was integrating the coaxial catheter design
`
`of Andersen with the Reiley balloon would have understood that the balloon would
`
`extend outside and beyond the outer catheter tube to allow for implementation of
`
`the coaxial design. Indeed, in this context, it would make no sense to have the
`
`balloon not extend outside and beyond the outer catheter tube.
`
`26.
`
` As I previously stated in paragraph 102 of my First Declaration,
`
`Reiley discloses “[a] balloon (10) for use in compressing cancellous bone and
`
`marrow (also known as medullary bone and trabecular bone) against the inner
`
`cortex of bones whether the bones are fractured or not.” In paragraph 104, I
`
`further stated that “Reiley praises the catheter design of intravascular catheters
`
`specifically identifying the Andersen catheter as ‘[a] particular improvement.’”
`
`(Ex. 1006 at p. 4 ll. 21-25.) In paragraph 38 of his declaration, Dr. Baroud
`
`references page 5, lines 25-33 of Reiley and states that “Reiley (Ex. 1006) does not
`
`teach 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 does not mention Andersen and also relates to balloon
`
`designs and not to the “coaxial catheter with inner and outer tubing” that is praised.
`
`Thus, Reiley’s statements about balloons (which Reiley endeavors to improve) are
`
`not relevant to whether the Andersen catheter design is separately praised as a
`
`particularly improved design. As I stated in paragraph 108 of my First Declaration
`
` - 20 -
`
`STRYKER EXHIBIT 1041, pg. 20
`
`
`
`Second Declaration of Neil J. Sheehan
`
`“a person of ordinary skill in the art would have had a reason, basis, or motivation
`
`to combine Reiley with Andersen, at a minimum, based upon the explicit teaching
`
`of Reiley itself.”
`
`27.
`
`In paragraph 42 of his declaration, Dr. Baroud states that “Reiley does
`
`not teach to use the balloon structures of Andersen.” In addition to the reasons I
`
`have set forth above that contradict this statement, i.e. “Reiley praises the catheter
`
`design of intravascular catheters specifically identifying the Andersen catheter”, I
`
`also stated in my First Declaration at paragraph 104 that “Reiley also suggests that
`
`Andersen be consulted for balloon choices.” (citing Ex. 1006 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 104, footnote
`
`2, the fact that “Reiley notes that ‘generally’ balloons may not provide ‘adequate
`
`cavity formation,’ [] has no relevance to the elements of Claims 1-12.” I agree
`
`with the Board’s conclusion that “we are not persuaded that Reiley would have
`
`discouraged combining the teachings of the references. . . . Although 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’ . . .
`
`this statement does not amount to teaching away from the claimed invention.”
`
`(Decision at 16.)
`
` - 21 -
`
`STRYKER EXHIBIT 1041, pg. 21
`
`
`
`Second Declaration of Neil J. Sheehan
`
`
`28.
`
`In paragraph 31 of my First Declaration, I provided my understanding
`
`that a person ordinarily skill in the art “would have a mechanical engineering
`
`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
`
`¶13.) 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 ‘505 patent
`
`disclosure and field of invention. The ‘505 patent broadly “relates to expandable
`
`structures, which, in use, are deployed in interior body regions of humans and
`
`other animals.” (Ex. 1001 at 1:13-15.) Interior body regions include at least “the
`
`vasculature and interior bone.” (Id. 1:26-27.) 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
`
` - 22 -
`
`STRYKER EXHIBIT 1041, pg. 22
`
`
`
`STRYKER EXHIBIT 1041, pg. 23
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
