UNITED STATES PATENT AND TRADEMARK OFFICE
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________
`
`STRYKER CORPORATION
`Petitioner,
`
`v.
`
`ORTHOPHOENIX, LLC,
`Patent Owner
`_________
`
`Case IPR2014-01433
`Patent 6,241,734 B1
`
`SECOND DECLARATION OF MARY E. JENSEN, M.D.
`
`
`
`STRYKER EXHIBIT 1041, pg. i
`
`STRYKER CORPORATION v. ORTHOPHOENIX, LLC
`
`IPR2014-01433
`
`
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________
`
`STRYKER CORPORATION
`Petitioner,
`
`v.
`
`ORTHOPHOENIX, LLC,
`Patent Owner
`_________
`
`Case IPR2014-01433
`Patent 6,241,734 B1
`
`SECOND DECLARATION OF MARY E. JENSEN, M.D.
`
`
`
`STRYKER EXHIBIT 1041, pg. i
`
`STRYKER CORPORATION v. ORTHOPHOENIX, LLC
`
`IPR2014-01433
`
`
`
`Second Declaration of Mary E. Jensen, M.D.
`
`
`
`1.
`
`I previously provided a declaration for the above-captioned inter
`
`partes review, entitled Declaration of Mary E. Jensen, M.D. (Stryker Exhibit
`
`1002, “First Declaration”), relating to U.S. Patent No. 6,241,734 (“734 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.
`
`Since providing the First Declaration, I have reviewed the Board’s
`
`Decision instituting IPR, the Patent Owner Response, and the Declaration of
`
`Gamal Baroud, Ph.D., each relating to the 734 patent. I also reviewed the exhibits
`
`submitted by Orthophoenix and referenced by Dr. Baroud in this IPR, as well as
`
`the transcript of Dr. Baroud’s deposition dated July 30 and 31, 2015, as well as the
`
`exhibits referenced in this declaration. While I disagree with many of the
`
`statements made by Dr. Baroud in his declaration and during his deposition, I
`
`respond to only a few issues raised below.
`
`3.
`
`As I previously stated in my First Declaration, it was understood by
`
`August 1998 that bone cement could be delivered at “low pressures” including
`
`pressures no greater than about 360 psi. (¶ 39.) Such pressures were often
`
`preferred by physicians so the cement delivery could be adjusted and controlled.
`
`(¶ 39.) Indeed, typical vertebroplasty procedures at the time of the invention used,
`
`- 1 -
`
`STRYKER EXHIBIT 1041, pg. 1
`
`IPR2014-01433
`
`
`
`Second Declaration of Mary E. Jensen, M.D.
`
`
`
`for example, syringes with a volume of 1 cc or greater, resulting in delivery
`
`pressures less than about 360 psi. (¶ 40.)
`
`4.
`
`Dr. Baroud states that, at times, certain syringes could have delivery
`
`pressures above 360 psi. (Ex. 2021 at ¶¶ 19-27.) Specifically, he states that “the
`
`delivery pressures of PMMA or cement in a 2 or 3-cc syringe into bone will greatly
`
`exceed 360 psi. Therefore, the pressures in Deramond are not necessarily at or
`
`below 360 psi.” (¶¶ 26-27.) I disagree with Dr. Baroud’s opinion. The 734 patent
`
`provides a specific definition of low delivery pressure: “low delivery pressure, i.e.,
`
`a pressure no greater than about 360 psi” and explains “[a]s used herein, a ‘low
`
`delivery pressure’ is equivalent to the pressure at which liquid is expressed from 1
`
`cc syringe by the application of moderate force to the syringe piston, which
`
`amounts to a pressure that is no greater than about 360 psi.” (734 patent, at 3:7-10,
`
`2:6-10; see also 16:65-66 (“[t]he application of low pressure (i.e., no greater than
`
`360 psi), which is uniformly applied by the syringe 104 . . . .”).) In other words,
`
`the 734 patent equates “a pressure that is no greater than about 360 psi” to “the
`
`pressure at which liquid is expressed from a 1 cc syringe by the application of
`
`- 2 -
`
`STRYKER EXHIBIT 1041, pg. 2
`
`IPR2014-01433
`
`
`
`Second Declaration of Mary E. Jensen, M.D.
`
`
`
`moderate force to the syringe.”1 As I explained previously, the patent specifically
`
`and repeatedly teaches the ordinarily skilled artisan that the claimed delivery
`
`devices include conventional syringes of 1 cc or larger.2 (¶¶ 45-47; 734 patent at
`
`2:6-10, 10:33-35, FIGS. 5, 24-25, 27, 33.) In fact, a conventional syringe is the
`
`preferred delivery device identified in the 734 patent. Thus, consistent with my
`
`prior opinion, the ordinarily skilled artisan would understand that “a delivery
`
`device to convey the material at a delivery pressure of no greater than about 360
`
`psi” includes such conventional syringes, i.e., syringes of 1 cc or greater. (¶¶ 44-
`
`45, 40, 65, 69 n.5.)
`
`5.
`
`Thus, the fact that such syringes at times could have pressures above
`
`
`1 This is consistent with references that I previously discussed (paragraph 40),
`
`which show, e.g., that 1 cc syringes have mean maximum pressures of about 360
`
`psi (with larger syringes having even lower pressures). (Ex. 1011 (Hayward) at
`
`Table 1.)
`
`2 As I previously explained (¶ 40), as the size of the syringe increases, the delivery
`
`pressure of the syringe decreases. Thus, 2-, 3-, and 5- cc syringes deliver
`
`materials at lower pressures than 1-cc syringes. I note that Dr. Baroud agreed
`
`with my conclusion (Ex. 2021, ¶¶ 19, 23, 24; Baroud Tr. at p. 241, lns. 3-15).
`
`- 3 -
`
`STRYKER EXHIBIT 1041, pg. 3
`
`IPR2014-01433
`
`
`
`Second Declaration of Mary E. Jensen, M.D.
`
`
`
`360 psi – a concept not mentioned or accounted for by the 734 patent – is
`
`irrelevant to whether the syringes can and do deliver material at pressures no
`
`greater than about 360 psi under normal operating conditions. In fact, Dr.
`
`Baroud’s declaration (paragraphs 19 and 23) confirms that 2, 3, and 5 cc syringes
`
`(such as those disclosed in Deramond) can and do deliver materials at a pressure
`
`no greater than about 360 psi under normal conditions.
`
`6.
`
`I further note that with respect to 5-cc syringes in particular, Dr.
`
`Baroud has stated that the normal operating pressure of a 5 cc syringe is in the
`
`range of 161 to 334 psi (paragraph 19), which is well under 360 psi. Moreover,
`
`Dr. Baroud testified in his deposition that 5-cc syringes will always operate at
`
`pressures of less than 360 psi. (p. 267.) In my First Declaration, paragraph 39, I
`
`referenced the Krebs article that states that “[h]igh injection pressures approaching
`
`20 atmospheres [294 psi] are reached during conventional vertebroplasty” and
`
`reporting average pressures of 246 and 250 psi for normal and wide 5-cc syringes.
`
`Krebs discloses that the average for a 5cc syringe is 1698 kPa, which is 246 psi.
`
`(Ex. 1012, p. E120.) Moreover, the Krebs article shows the 5-cc syringe always
`
`operating at pressures much less than 360 psi, including during the first phase of
`
`injection. (Ex. 1012, Fig. 3, Table 1.)
`
`7.
`
`As Dr. Baroud acknowledged in his deposition (p. 278, lines 5-9),
`
`- 4 -
`
`STRYKER EXHIBIT 1041, pg. 4
`
`IPR2014-01433
`
`
`
`Second Declaration of Mary E. Jensen, M.D.
`
`
`
`there are physical limits on the pressures that a physician can manually generate
`
`using a syringe. Some of Dr. Baroud’s high-end pressure calculations for 1-, 2-,
`
`and 3-cc syringes are at odds with statements made regarding delivery pressures
`
`that can be generated by a physician. For example, in his declaration, Dr. Baroud
`
`states that “the delivery pressure that a physician can generate in 2 or 3-cc syringe .
`
`. . can reach pressures of up to 984.45 psi” and “the delivery pressure generated in
`
`the 1-cc syringe is in the range of 1640.76 +/- 575.24 psi.”3 (Ex. 2021, ¶¶ 23-24.)
`
`However, U.S. Patent Publication No. 2007/0185496, which was marked as
`
`Exhibit 1039 and identifies Dr. Baroud as an inventor, states that the 6900 KPa
`
`injection pressure, which is about 1000 psi, is “well beyond the limit of what of the
`
`surgeon can manually generate to inject cement with a standard syringe.”
`
`(Paragraph 9.) The application further states that “[p]ressures generated one-
`
`handed with a standard 2-cc syringe have demonstrated maximum obtained
`
`pressures in the order of 1700 KPa [247 psi].” (Paragraph 9.) This application
`
`later identifies that “the physical limit of the physician to be 1700 KPa,” which is
`
`247 psi. (Paragraph 54.) This is consistent with Krebs conclusion under “Key
`
`
`3 I note that, in paragraph 25, citing the Hayward reference, Dr. Baroud states that
`
`a 1-cc syringe can deliver materials as low as 216 psi but up to 728 psi.
`
`- 5 -
`
`STRYKER EXHIBIT 1041, pg. 5
`
`IPR2014-01433
`
`
`
`Second Declaration of Mary E. Jensen, M.D.
`
`
`
`Points”
`
`that “Peak
`
`injection pressures during conventional vertebroplasty
`
`approached on average 2000 kPa (20 atmospheres),” which is 290 psi. (Ex. 1012,
`
`p. E121.) Thus, Dr. Baroud’s estimates for theoretical high-end delivery pressures
`
`appear to suggest peak pressures well above what he has previously identified as
`
`the physical limits of the physician.
`
`8.
`
` In paragraph 22 of his declaration, Dr. Baroud states that “Krebs
`
`used an 8-gauge needle in his experiments” in connection with its syringes,
`
`apparently attempting to distinguish it from the needles that are attached to the
`
`syringes in Deramond. In my opinion, the size of the needle, e.g., 8-, 10-, or 15-
`
`gauge, attached to a syringe has no bearing on the delivery pressure of the syringe
`
`itself, which is the delivery pressure at issue in the claims. The claims state that
`
`the apparatus includes “a delivery device to convey the material . . . at a delivery
`
`pressure of no greater than about 360 psi.” This is supported by the 734 patent,
`
`which defines “low delivery pressure” (see above) to be independent of needle size
`
`and simply references delivery from the syringe itself. (734 patent at 2:6-10.)
`
`9.
`
`As I previously stated in my First Declaration, in my opinion, a person
`
`of ordinary skill in the art would have understood that material could be delivered
`
`into bone using the coaxial technique disclosed in Deramond (Fig. 4A), which was
`
`well known at the time of the invention. (¶ 71.) Dr. Baroud states that the coaxial
`
`- 6 -
`
`STRYKER EXHIBIT 1041, pg. 6
`
`IPR2014-01433
`
`
`
`Second Declaration of Mary E. Jensen, M.D.
`
`
`
`technique of Deramond “simply does not work” because “if the 15-gauge needle is
`
`inserted into the 10-gauge needle in a coaxial arrangement, the shorter 15-gauge
`
`needle cannot extend beyond the end of the longer 10-needle [sic, 10-gauge
`
`needle] (which would be required if the 15-gauge needle is to serve as a tamping
`
`instrument as discussed below).” (Ex. 2021 , ¶ 30.) Dr. Baroud apparently rests
`
`this conclusion on the needle lengths disclosed on page 285 of the Deramond
`
`reference. I disagree with Dr. Baroud’s conclusion. Figure 4A, reproduced from
`
`my First Declaration,
`
`illustrates
`
`the coaxial
`
`technique using a 15-gauge needle within a 10-
`
`gauge needle. Figure 4A clearly shows that the 15-
`
`gauge needle extends beyond the end of the 10-
`
`gauge needle. The fact that page 285 of Deramond
`
`identifies 10- and 15-gauge needles of particular
`
`lengths (10 to 15 cm and 5 to 7 cm, respectively)
`
`does not negate the clear depiction in Figure 4A,
`
`which shows a 15-gauge needle that is longer than a 10-gauge needle.4 Needles of
`
`
`4 In any event, the skilled artisan would not understand page 285 of Deramond to
`
`be a comprehensive list of every tool used in the procedures described in the
`
`
`
`- 7 -
`
`STRYKER EXHIBIT 1041, pg. 7
`
`IPR2014-01433
`
`
`
`Second Declaration of Mary E. Jensen, M.D.
`
`
`
`varying lengths within the same gauge were available off-the-shelf as of August
`
`1998. Thus, there were several 15-gauge needles available at the time of the
`
`invention including needles that were longer than 10-gauge needles. A person of
`
`ordinary skill in the art would have understood to select a needle of appropriate
`
`length for the coaxial technique and Deramond discloses that in Figure 4A.
`
`10. Dr. Baroud further states that the 15-gauge needle with stylet could
`
`not be “effectively” used to push material through the 10-gauge needle because
`
`there would be a space between the two needles. (Ex. 2021 at ¶¶ 31-33.) I
`
`disagree. I first note that there is nothing in the claims of the 734 patent that
`
`require any particular level of “effectiveness” for the tamping instrument. There is
`
`also nothing in the claims that precludes a space between the tamping instrument
`
`(including the nested stylet and nozzle of claim 12) and the subcutaneous cannula.
`
`Indeed, some type of space must exist between the tamping instrument and the
`
`access cannula or there could be no tamping. In this example, the space between
`
`the access cannula and the tamping instrument would not impede the ordinary
`
`skilled artisan from using the nested nozzle and stylet as a tamping instrument
`
`
`
`reference. For example, page 285 does not reference 5 cc syringes, yet 5 cc
`
`syringes are referenced elsewhere in the Deramond reference (e.g., page 287).
`
`- 8 -
`
`STRYKER EXHIBIT 1041, pg. 8
`
`IPR2014-01433
`
`
`
`Second Declaration of Mary E. Jensen, M.D.
`
`
`
`within the subcutaneous cannula. An ordinarily skilled artisan such as a physician
`
`would have understood that residual material could be cleared from the cannula by
`
`repeatedly pushing the tamping instrument (e.g., the 15-gauge needle with stylet)
`
`within the lumen of the subcutaneous cannula (e.g., the 10-gauge needle).
`
`11. Moreover, if the ordinary skilled artisan preferred a tighter fit between
`
`the cannula and tamping instrument, he or she could have selected a larger-
`
`diameter needle as a tamping instrument. Many different needle gauges (with
`
`stylets) were available off-the-shelf by the time of the invention. A 13-gauge
`
`needle (outer diameter about 2.4 mm) is an example of a larger-diameter
`
`instrument that would have been available off-the-shelf for use within a 10-gauge
`
`needle (inner diameter about 2.7 mm). (Ex. 2021, Machinery Handbook, p. 2520.)
`
`Indeed, in performing coaxial techniques such as that depicted in Deramond, the
`
`physician understood to select a particular gauge depending on the anatomical
`
`location of the specific procedure as well as the type and amount of material being
`
`delivered. For example, a smaller needle (e.g., 15-gauge) would have generally
`
`been preferred for the cervical vertebra to avoid damage to the carotid artery and
`
`other delicate vasculature. On the other hand, a larger needle (11-gauge) would
`
`have generally been preferred for procedures in the thoracic and lumbar vertebra to
`
`deliver a greater amount of filling material to these larger vertebrae.
`
`- 9 -
`
`STRYKER EXHIBIT 1041, pg. 9
`
`IPR2014-01433
`
`
`
`Second Declaration of Mary E. Jensen, M.D.
`
`
`
`12. As I previously stated in my First Declaration, Kuslich (Ex. 1009)
`
`describes delivering filling material to an expandable implant bag 40 that is
`
`inserted through a subcutaneous cannula 54 into a cavity in bone. (¶ 161.) Dr.
`
`Baroud states that “figures 5 and 6 show a picture of an intervertebral disk not a
`
`bone.” (Ex. 2021 at ¶ 35.) However, as I previously stated, while Kuslich does
`
`involve delivering filling material into an intervertebral disk, it also discloses
`
`delivering filling material into bone. This is shown in figures 4, 5, and 6 of
`
`Kuslich, which depict removal of bone of the vertebra (circled below) to expose
`
`cancellous bone to allow for fusion of the two vertebrae across the disk space.
`
`
`
`- 10 -
`
`STRYKER EXHIBIT 1041, pg. 10
`
`IPR2014-01433
`
`
`
`Second Declaration of Mary E. Jensen, M.D.
`
`
`
`This is further supported by claim 1 of Kuslich, which states that the cavity is
`
`formed by “boring an opening into an annulus of a disc, said disc including a
`
`nucleus and end plates, each end plate being adjacent a vertebra, excising out at
`
`least a portion of the nucleus and a portion of the end plates of said disc and bone
`
`of adjacent vertebrae to said disc to expose healthy bone.” (Ex. 1009 at claim 1.)
`
`Indeed, without removing bone, a physician could not fuse the two vertebrae and
`
`this would frustrate the entire purpose of Kuslich.
`
`13.
`
`In paragraph 37, Dr. Baroud references “physiological compressive
`
`loads exceeding 1000 psi.” As Kuslich clearly explains, this is the mechanical
`
`forces acting on the spinal disc, e.g., “when a heavy load is lifted,” and has nothing
`
`to do with the delivery pressure of the Kuslich device. (Ex. 1009 at 1:50-52.)
`
`14.
`
`In paragraph 38, Dr. Baroud states that the implanted bag of Kuslich
`
`“would leak” if filled with bone cement. This is irrelevant to claim 12 of the 734
`
`patent, which requires delivery of “material” and does not limit the material to
`
`bone cement (and also does not involve any bag to constrain bone cement). The
`
`734 patent describes many materials that can be selected for delivery into bone
`
`including autograft and allograft tissue, which is consistent with what is disclosed
`
`in Kuslich. (Ex. 1001 at 10:22-26; Ex. 1009 at 9:57-60.) In any event, Kuslich
`
`specifically states that the bag contains the material. (Ex. 1009 at 7:18-20.)
`
`- 11 -
`
`STRYKER EXHIBIT 1041, pg. 11
`
`IPR2014-01433
`
`
`
`STRYKER EXHIBIT 1041, pg. 12
`
`IPR2014-01433
`
`STRYKER EXHIBIT 1041, pg. 12
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
