Stryker Corporationv.Orthophoenix, LLC

Patent Trial and Appeal Board

Feb 5, 2016

09134323 (P.T.A.B. Feb. 5, 2016)

Trials@uspto.gov Paper 34
Tel: 571-272-7822 Entered: February 5, 2016

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
_______________

Before JOSIAH C. COCKS, RICHARD E. RICE, and
SCOTT A. DANIELS, Administrative Patent Judges.

RICE, Administrative Patent Judge.

FINAL WRITTEN DECISION
35 U.S.C. § 318(a) and 37 C.F.R. § 42.73(b)

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I. INTRODUCTION
A. Background/Summary
Stryker Corporation (“Petitioner”) filed a Corrected Petition (Paper 4,
“Petition” or “Pet.”) for inter partes review of claims 1–21 of U.S. Patent
No. 6,241,734 B1 (Ex. 1001, “the ’734 Patent”). We instituted an inter
partes review as to all of the challenged claims. Paper 11 (“Dec.”), 2. After
institution, Orthophoenix, LLC (“Patent Owner”) filed a Patent Owner
Response (Paper 19, “PO Resp.”), to which Petitioner filed a Reply
(Paper 24, “Pet. Reply”).
An oral hearing was held on November 4, 2015. The transcript of the
hearing has been entered into the record. Paper 33 (“Tr.”).
The grounds for trial were as follows:

References Basis Claims Challenged
Deramond
1
§ 102(b) 15, 16, 19, and 20
Deramond § 103(a) 1–21
Kuslich
2
§ 103(a) 12

Petitioner relied on first and second Declarations of Mary E. Jensen,
M.D. (Exs. 1002, 1041), and Patent Owner relied on a Declaration of Gamal
Baroud, Ph.D. (Ex. 2021).

1
Hervé Deramond et al., Percutaneous Vertebroplasty, 1:2 SEMINARS IN
MUSCULOSKELETAL RADIOLOGY 285–95 (June 1997) (Ex. 1003).
2
U.S. Patent No. 5,549,679 to Kuslich, issued August 27, 1996 (Ex. 1009).
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We have jurisdiction under 35 U.S.C. § 6(c). The evidentiary
standard is a preponderance of the evidence. See 35 U.S.C. § 316(e);
37 C.F.R. § 42.1(d). This Final Written Decision is issued pursuant to
35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
For the reasons explained below, we determine that Petitioner has
shown, by a preponderance of the evidence, that claims 15, 16, 19, and 20
are unpatentable as anticipated by Deramond and claims 1–21 are
unpatentable as obvious over Deramond; however, Petitioner has not shown,
by a preponderance of the evidence, that claim 12 is unpatentable as obvious
over Kuslich.
B. Related Proceedings
Petitioner is named as a defendant in a federal district court case
involving the ’734 Patent (Orthophoenix, LLC. v. Stryker Corporation, Case
No. 13-1628-LPS (D. Del.)). Pet. 1; Paper 6, 2. Petitioner also is involved
in an inter partes review (IPR2014-01434) of U.S. Patent No. 7,153,307 B2,
which claims priority from the ’734 Patent. Pet. 1; Paper 6, 2.
C. The ’734 Patent
The ’734 Patent relates to an apparatus for introducing material into
bone through a subcutaneous cannula. Ex. 1001, 2:3–5. The apparatus
includes a delivery device to convey the material at “a low delivery
pressure,” which is defined in the patent as “equivalent to the pressure at
which liquid is expressed from [a] 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.” Id. at 2:5–10. A cavity forming instrument may
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be deployed through the cannula to compress cancellous bone
3
and form a
cavity. Id. at 3:17–19.
Figures 25 and 26 of the ’734 Patent are reproduced below.

Figure 25 is a perspective view of conventional syringe 104 being joined to
injection nozzle 106, and Figure 26 is a perspective view showing the nozzle
being deployed through cannula instrument 30 such that the nozzle extends a
selected distance beyond the distal end of the cannula instrument and into
cavity 168 of vertebral body 148. Id. at 4:41–47, 10:32–33, 16:1–9.
As described in the patent, tamping instrument 108 is used to displace
residual material that remains in the cannula instrument after the nozzle has
been withdrawn. Id. at 16:42–59; Fig. 30.

3
“Spongy porous bone tissue, which forms the interior of a bone and has a
lower density than the surrounding cortical bone.” Elizabeth Martin et al., A
DICTIONARY OF NURSING (5th ed. 2008).
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D. Illustrative Claim
Claims 1, 12, and 15 are independent. Claim 1 is illustrative of the
claimed subject matter, and is reproduced below:
1. Apparatus for introducing material
into bone through a subcutaneous cannula, the
apparatus including
a subcutaneous cannula,
a delivery device to convey the material at a
delivery pressure of no greater than about 360 psi,
a nozzle instrument capable of advancement
into the subcutaneous cannula and comprising a
proximal fitting to couple the nozzle instrument to
the delivery device and a nozzle terminus through
which the material conveyed by the delivery
device enters bone at the delivery pressure, and
a tamping instrument capable of
advancement into the subcutaneous cannula and
having a tamping terminus which, during the
advancement, urges material residing in the
subcutaneous cannula into bone.

Id. at 19:63–20:8.
II. ANALYSIS
A. Claim Construction
In an inter partes review, claim terms in an unexpired patent are given
their broadest reasonable interpretation in light of the specification of the
patent in which they appear. 37 C.F.R. § 42.100(b); see also In re Cuozzo
Speed Techs., LLC, 793 F.3d 1268, 1278, 1279 (Fed. Cir. 2015) (“We
conclude that Congress implicitly approved the broadest reasonable
interpretation standard in enacting the AIA” and “the standard was properly
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adopted by PTO regulation.”), cert. granted sub nom. Cuozzo Speed Techs.
LLC v. Lee, 84 U.S.L.W. 3218 (Jan. 15, 2016) (No. 15-446). Under that
standard, a claim term generally is given its ordinary and customary
meaning, as would be understood by one of ordinary skill in the art in the
context of the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249,
1257 (Fed. Cir. 2007). The claims, however, “‘cannot be divorced from the
specification and the record evidence.’” Microsoft Corp. v. Proxyconn, Inc.,
789 F.3d 1292, 1298 (Fed. Cir. 2015) (quoting In re NTP, Inc., 654 F.3d
1279, 1288 (Fed. Cir. 2011)). Applying these principles, we interpret certain
claim limitations as follows:
1. “subcutaneous cannula”
In the Decision to Institute, we determined that the broadest
reasonable interpretation consistent with the Specification of “subcutaneous
cannula” is a cannula that has an interior lumen running throughout its entire
length and that is capable of being extended through soft tissue into bone.
Dec. 7. Neither party proposes any change to that interpretation, and our
review of the evidence does not indicate that any change is necessary.
Consequently, we maintain our interpretation.
2. “nozzle instrument”
In the Decision to Institute, we determined that the broadest
reasonable interpretation consistent with the Specification of “nozzle
instrument” is a device with an opening through which fluid can be expelled.
Id. at 8. Neither party proposes any change to that interpretation, and our
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review of the evidence does not indicate that any change is necessary.
Consequently, we maintain our interpretation.
3. “a delivery device to convey the material at a
delivery pressure of no greater than about 360 psi”
All the independent claims require “a delivery device to convey the
material at a delivery pressure of no greater than about 360 psi,” or the
equivalent. Patent Owner contends that the “delivery device” limitation
excludes any delivery device that is capable of conveying the material at a
delivery pressure greater than about 360 psi. See PO Resp. 1, 14, 16, 19,
24; Tr. 40:24–41:8, 41:25–43:1, 43:24–46:3, 50:10–52:22. For example,
Patent Owner contends that “2- or 3-cc syringes would have peak pressures
exceeding 360 psi” and, therefore, do not meet the delivery device
limitation, even though such syringes also can convey the material at a
delivery pressure below 360 psi. PO Resp. 16; see id. at 9–10 (citing Ex.
2021 ¶¶ 18–24, 26).
4

Petitioner replies that Patent Owner’s “attempt to avoid the prior art
by construing the claims to be inconsistent with the specification and to
exclude the preferred embodiment is legally wrong.” Pet. Reply 2.
Petitioner asserts that the ’734 Patent “makes clear that the preferred and
only embodiment for the claimed low pressure delivery device is a

4
Relying on testimony from its expert, Dr. Baroud, Patent Owner asserts,
for example, that a physician can convey material in 2- and 3-cc syringes at
delivery pressures within the range 339.69 psi to 703.69 psi, i.e., 521.69 psi
+/- 182 psi. PO Resp. 9–10 (citing Ex. 2021 ¶¶ 18–24, 26).
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‘conventional syringe.’” Id. at 12. According to Petitioner, “conventional
syringes are the claimed delivery device and need only be capable of
conveying material at pressures no greater than 360 psi.” Id. at 2; see also
id. at 9 (“[A]s long as the prior art discloses a structure (e.g., a syringe) that
is capable of performing the claimed function (e.g., conveying material at a
pressure no greater than about 360 psi), the art satisfies the limitation.”)
(citing In re Schreiber, 128 F.3d 1473, 1478–79 (Fed. Cir. 1997)).
Petitioner argues that “nothing in the patent or claims require[s] the delivery
device to ‘always . . . reside below 360 psi.’” Id. at 1–2.
We agree with Petitioner. The ’734 Patent Specification discloses that
applying “moderate force” to the piston of a 1-cc syringe can convey the
bone-filling material at a delivery pressure less than, or equal to, 360 psi.
Ex. 1001, 2:5–10 (“the pressure at which liquid is expressed from [a] 1 cc
syringe by the application of moderate force to the syringe piston . . . is no
greater than about 360 psi” (emphasis added)). A person of ordinary skill
reading the Specification would understand, moreover, that applying more
than just “moderate force” to the piston of a 1-cc syringe can convey the
material at a delivery pressure higher than 360 psi. Id. At the oral hearing,
Patent Owner agreed that a person of ordinary skill would have that
understanding. Tr. 41:25–42:8. Accordingly, the patent disclosure supports
Petitioner’s argument that a delivery device capable of conveying the
material at a delivery pressure less than, or equal to, 360 psi meets the
delivery device limitation, even if the device also is capable of conveying
the material at a delivery pressure higher than 360 psi.
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Contradicting the patent disclosure that a 1-cc syringe is capable of
conveying bone-filling material at a pressure less than 360 psi, Patent Owner
asserts in its Patent Owner Response that “the delivery pressure generated in
the 1-cc syringe, which is disclosed in the ’734 patent and discussed by
[Dr.] Jensen in her Declaration, is estimated to be in the range of 1640.76 +/-
575.24 psi,” i.e., from 1065.52 psi to 2,216.00 psi. PO Resp. 10 (citing
Ex. 2021 ¶ 25).
5
Dr. Baroud testifies in paragraph 24 of his Declaration,
based on an analysis of the Krebs reference (Ex. 1012),
6
that “the delivery
pressure generated in the 1-cc syringe is in the range of 1640.76 ± 575.24
psi,” as Petitioner asserts. Ex. 2021 ¶ 24. Dr. Baroud also testifies,
however, based on an analysis of the Hayward reference (Ex. 1011),
7
“that,
with 68 percent confidence[,] the measured pressure of delivery [for the
1-ml syringe in Hayward] will be in the range 472-256=216 psi to 472+265=
728 psi.” Ex. 2021 ¶ 25. Dr. Baroud does not explain whether there is any
difference between the 1-ml syringe in Hayward and the 1-cc syringe in
Krebs,
8
or otherwise reconcile the apparently-contradicting opinions in

5
The citation to paragraph 25 of Dr. Baroud’s Declaration is a clear
typographical error. The correct citation is to paragraph 24.
6
Jörg Krebs et al., Clinical Measurements of Cement Injection Pressure
During Vertebroplasty, 30:5 SPINE E118–22 (2005) (hereinafter “Krebs”).
7
W.A.P. Hayward et al., Pressure generated by syringes: implications for
hydrodissection and injection of dense connective tissue lesions, 40 SCAND.
J. RHEUMATOL. 379–82 (2011) (hereinafter “Hayward”).
8
We note that “1 cc” and “1 ml” are equivalent units of measurement.
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paragraphs 24 and 25 of his Declaration. Accordingly, we give his
testimony regarding the 1-cc syringe in Krebs little weight.
Furthermore, as Petitioner argues, the Specification describes a
preferred embodiment in which “the material is injected by use of a
conventional syringe 104.” Ex. 1001, 10:32–33; see Pet. Reply 5. As
described, conventional syringe 104 conveys the material at low delivery
pressure, i.e., “no greater than 360 psi.” Ex. 1001, 16:65–67. The
description in the Specification of conventional syringe 104 is consistent
with Petitioner’s contention that “the claimed delivery device . . . need only
be capable of conveying material at pressures no greater than 360 psi.”
Pet. Reply 2. At the oral hearing, Patent Owner conceded that the
conventional syringe disclosed in the Specification is capable of conveying
material at pressures either lower or higher than 360 psi. Tr. 51:10–52:22.
For these reasons, we determine that the broadest reasonable
interpretation consistent with the Specification of “a delivery device to
convey the material at a delivery pressure of no greater than about 360 psi”
is a delivery device that is capable of conveying the material at a delivery
pressure less than, or equal to, about 360 psi, and does not exclude such a
device if it also is capable of conveying the material at a delivery pressure
greater than about 360 psi.
B. Anticipation of Claims 15, 16, 19, and 20 by Deramond
To anticipate a patent claim under 35 U.S.C. § 102, “a single prior art
reference must expressly or inherently disclose each claim limitation.”
Finisar Corp. v. DirecTV Group, Inc., 523 F.3d 1323, 1334 (Fed. Cir. 2008).
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Under the principles of inherency, if the prior art necessarily functions in
accordance with, or includes, the claim limitations, it anticipates, even
though artisans of ordinary skill may not have recognized the inherent
characteristics or functioning of the prior art. MEHL/Biophile Int’l Corp. v.
Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999) (citation omitted); In re
Cruciferous Sprout Litig., 301 F.3d 1343, 1349–50 (Fed. Cir. 2002).
Petitioner contends that Deramond anticipates claims 15, 16, 19,
and 20. Pet. 11. Deramond describes tools used in vertebroplasty
procedures where bone cement is delivered through needles into vertebral
bodies weakened by disease. Ex. 1003, 285–290. Patent Owner presents
arguments only as to independent claim 15 and relies on those arguments as
to dependent claims 16, 19, and 20. PO Resp. 14.
Petitioner provides argument and a claim chart, supported by the
testimony of its expert, Dr. Jensen, demonstrating that Deramond discloses,
expressly or inherently, each limitation of claims 15, 16, 19, and 20. Pet.
11–17; Ex. 1002 ¶¶ 56–68. Claim 15 recites:
15. Apparatus for introducing material
into bone through a subcutaneous cannula, the
apparatus comprising a subcutaneous cannula, a
delivery device to convey the material into the
subcutaneous cannula at a delivery pressure of no
greater than about 360 psi, and a tamping
instrument having a tamping terminus which,
during advancement of the tamping instrument in
the subcutaneous cannula, urges material residing
in the subcutaneous cannula into bone.
Ex. 1001, 20:63–21:3.
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1. “a delivery device to convey the material into the
subcutaneous cannula at a delivery pressure of
no greater than about 360 psi”
With respect to the “delivery device” limitation, Petitioner asserts, and
we agree, that Deramond discloses 2- and 3-cc luer-lock syringes, and that
those syringes, inherently, are capable of conveying bone-filling material
into a subcutaneous cannula at a delivery pressure less than, or equal to,
about 360 psi. Pet. 12–14 (citing Ex. 1002 ¶¶ 40, 59, 61; Ex. 1003, 285;
Ex. 1011 (Hayward), 379; Ex. 1012 (Krebs), E1118). These facts are
undisputed. See PO Resp. 9–10 (asserting, based on testimony from Dr.
Baroud (Ex. 2021 ¶ 23), that a physician can convey material in 2- and 3-cc
syringes at delivery pressures within the range 339.69 psi to 703.69 psi);
Tr. 51:10–52:22.
In response, Patent Owner argues that “the pressures in Deramond are
not inherently constrained to remain below [about 360 psi]” and “do not
always necessarily reside below 360 psi, negating any inherency.”
PO Resp. 1, 13. Patent Owner also argues that Deramond’s 2- and 3-cc
syringes are capable of conveying bone-filling material at a delivery
pressure considerably greater than 360 psi and, therefore, do not meet the
delivery pressure limitation, even though such syringes also can convey
material at a delivery pressure below 360 psi. See supra Section II.A.3;
PO Resp. 9–10 (citing Ex. 2021 ¶¶ 18–24, 26). Based on these arguments,
Patent Owner contends that Petitioner has failed to demonstrate that
Deramond discloses the “delivery device” limitation of claim 15 (and claims
16, 19, and 20, which depend from claim 15). PO Resp. 13–14.
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Patent Owner’s arguments are based on an erroneous claim
construction. As interpreted above, the “delivery device” limitation requires
a delivery device that is capable of conveying bone-filling material at a
delivery pressure less than, or equal to, about 360 psi, and does not exclude
such a device if it also is capable of conveying the material at a delivery
pressure greater than about 360 psi. It is undisputed that Deramond’s 2- and
3-cc syringes are capable of conveying bone-filling material at a delivery
pressure less than, or equal to, about 360 psi, which is all that the delivery
pressure limitation requires under a proper claim interpretation.
2. “a subcutaneous cannula”
Dr. Jensen testifies, and we agree, that Deramond discloses the use of
10- and 15-gauge needles as subcutaneous cannulas for introducing material
into bone. Ex. 1002 ¶ 65. Patent Owner does not challenge Dr. Jensen’s
testimony. PO Resp. 9–14.
3. “a tamping instrument having a tamping terminus which,
during advancement of the tamping instrument in the
subcutaneous cannula, urges material residing in the
subcutaneous cannula into bone”
With respect to the “tamping instrument” limitation, Dr. Jensen
testifies, and we agree, that Deramond discloses the use of a mandrel or
stylet as a tamping instrument:
The Deramond Article describes the use of a mandrel (stylet) as
a tamping instrument, i.e., after cement is delivered through the
cannula, the mandrel is inserted into the needle urging residual
material in the cannula into the vertebral body: “Once the
cement injection is achieved, the needle is slowly pulled back to
the cortical bone while pushing the mandred [sic, mandrel] into
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the needle.” (p. 287.) The mandrel is a tamping instrument and
the end of the mandrel is the tamping terminus. An example of
a mandrel/stylet in the cannula is shown in Figure 4A, p. 288.
Moreover, a photograph after tamping is shown in Figure 4F,
p. 290 . . . .

Ex. 1002 ¶ 65. Patent Owner does not challenge Dr. Jensen’s testimony.
PO Resp. 9–14.
Based on the evidence set forth in the Petition, and for the reasons
given, we conclude that Petitioner has shown, by a preponderance of the
evidence, that Deramond anticipates claims 15, 16, 19, and 20.
C. Obviousness of Claims 1–21 over Deramond
A claim is unpatentable for obviousness under 35 U.S.C. § 103(a) if
the differences between the subject matter sought to be patented and the
prior art are such that the subject matter as a whole would have been obvious
at the time the invention was made to a person having ordinary skill in the
art to which the subject matter pertains. See KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 406 (2007). A patent claim composed of several elements,
however, is not proved obvious merely by demonstrating that each of its
elements was known, independently, in the prior art. Id. at 418. In
analyzing the obviousness of a combination of prior art elements, it can be
important to identify a reason that would have prompted one of skill in the
art to combine the elements in the way the claimed invention does. Id. A
precise teaching directed to the specific subject matter of a challenged claim
is not necessary to establish obviousness. Id. Rather, “any need or problem
known in the field of endeavor at the time of invention and addressed by the
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patent can provide a reason for combining the elements in the manner
claimed.” Id. at 420. The question of obviousness is resolved on the basis
of underlying factual determinations, including: (1) the scope and content of
the prior art; (2) any differences between the claimed subject matter and the
prior art; (3) the level of skill in the art; and (4) objective evidence of
nonobviousness, i.e., secondary considerations, if in evidence.
9
Graham v.
John Deere Co., 383 U.S. 1, 17–18 (1966).
Petitioner contends that Deramond, in view of the knowledge of a
person of ordinary skill in the art, renders obvious each of claims 1–21.
Pet. 17–27; Ex. 1002 ¶¶ 69–93. Petitioner provides the following definition
of a person of ordinary skill in the art:
A person of ordinary skill in the art relating to the subject
matter of the 734 patent would be a physician or a biomedical
engineer with a number of years of experience, e.g., three to
five years, in the field of orthopedic technology or minimally‐
invasive surgery and, in particular, minimally invasive
radiological procedures. This person would be experienced in
performing, and/or designing devices for performing,
minimally invasive procedures such as vertebroplasty.
Pet. 17–18 (citing Ex. 1002 ¶ 13).
Patent Owner does not dispute Petitioner’s assessment of a person of
ordinary skill in the art, and we accept it in the context of this Final Written
Decision.

9
Patent Owner does not assert any secondary considerations in the Patent
Owner Response.
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1. Claim 1
Petitioner asserts that all but two of the limitations of claim 1 overlap
the limitations of claim 15. Id. at 18. With respect to the overlapping
limitations, including the delivery pressure limitation, Petitioner largely
relies upon its anticipation analysis, discussed above. Id.; see supra Section
II.B. The two non-overlapping limitations are: (1) a nozzle instrument that
is capable of advancement into the subcutaneous cannula, and that comprises
a proximal fitting to couple the nozzle instrument to the delivery device and
a nozzle terminus through which the material conveyed by the delivery
device enters bone at the delivery pressure; and (2) a tamping instrument
capable of advancement into the subcutaneous cannula. Id. As discussed
below, Petitioner asserts that Deramond discloses, or suggests, both the
nozzle and tamping instrument limitations. Id. at 18–19. Dr. Jensen
supports Petitioner’s obviousness contentions as to claim 1 with testimony
and a claim chart. Ex. 1002 ¶ 71.
Dr. Jensen testifies that Deramond, in Figure 4A, discloses a coaxial
embodiment for removing cancellous bone, where a 10-gauge needle is used
as a subcutaneous cannula and a 15-gauge needle (with stylet) is advanced
through the 10-gauge needle. Id. (citing Ex. 1003, Fig. 4A). Dr. Jensen also
testifies that Deramond, in Figure 1, discloses a different embodiment
utilizing a 15-gauge needle for delivering cement, where a “luer‐lock syringe
is coupled to the 15‐gauge needle and cement is delivered through the 15‐
gauge needle to the vertebral body through the terminus at the delivery
pressure.” Id. In Dr. Jensen’s opinion, given Deramond’s disclosure of
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using a 15-gauge needle for delivering cement, a person of ordinary skill
would have used Deramond’s coaxial embodiment for delivering cement as
well as removing cancellous bone. Id. Dr. Jensen explains:
This type of coaxial system was well known at the time the
‘734 patent was filed. Because it may be more desirable to
access a part of the vertebral body with a smaller needle, a
physician would be motivated to deliver cement in this coaxial
system if he or she wanted delivery to a precise location (e.g.,
to a metastasis).

Id. We agree with Dr. Jensen’s rationale for combining the two
embodiments in Deramond; and we further agree, as Petitioner asserts, that
Deramond discloses, or suggests: the luer-lock syringe includes a “proximal
fitting”; the 10-gauge needle is a “subcutaneous cannula”; the 15-gauge
needle corresponds to the “nozzle instrument”; and the mandrel or stylet
(discussed supra in Section II.B.3) is a “tamping instrument.” Pet. 18–19;
see Ex. 1002 ¶¶ 70–71.
Patent Owner responds that the requirement for a delivery device
having a delivery pressure of “no greater than about 360 psi” is not met by
Deramond. PO Resp. 16. As discussed above, however, Patent Owner’s
arguments are based on an erroneous claim construction, and we are
persuaded that Deramond’s 2- and 3-cc luer-lock syringes, inherently,
disclose the “delivery device” limitation. See supra Section II.B.1.
Furthermore, we are persuaded that substituting a conventional syringe
meeting the “delivery device” limitation for Deramond’s 2- or 3-cc luer-lock
syringe would have amounted to the mere substitution of one element for
another known in the field, to yield predictable results. See Pet. 21; KSR,
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550 U.S. at 416 (“[W]hen a patent claims a structure already known in the
prior art that is altered by the mere substitution of one element for another
known in the field, the combination must do more than yield a predictable
result.”) (citing United States v. Adams, 383 U.S. 39, 50–51 (1966)).
For the reasons given, we conclude that Petitioner has shown, by a
preponderance of the evidence, that claim 1 would have been obvious over
Deramond.
2. Claim 12
Claim 12 contains limitations similar to claims 1 and 15, but also
recites a “nozzle bore through which the material conveyed by the delivery
device enters bone at the delivery pressure,” a “stylet capable of
advancement into the nozzle bore through the proximal fitting to close the
nozzle bore,” and a “tamping instrument” (formed by combining the nozzle
instrument with the stylet) to urge residual material from the subcutaneous
cannula. Ex. 1001, 20:48–55; see Pet. 19–21. With respect to those
limitations, we agree with Dr. Jensen’s obviousness analysis:
Deramond discloses a coaxial embodiment where a 15‐gauge
needle is inserted into a 10‐gauge needle with a stylet shown
within the 15‐gauge needle. (See Figure 4A.) The article
separately explains that material can be delivered through a 15‐
gauge needle (Fig. 1). . . . [I]t would have been obvious to a
person of ordinary skill in the art that material could be
delivered (as well as removed) with the coaxial embodiment
with the 15‐gauge needle serving as a nozzle in that context.
Likewise, a person of ordinary skill in the art would have
understood that the stylet within the 15‐gauge needle (shown in
Fig. 4A) could be nested with the 15‐gauge needle to form a
tamping instrument for the 10‐gauge cannula.
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Ex. 1002 ¶ 72.
Patent Owner responds that the co-axial embodiment disclosed in
Deramond is not capable of performing the functional requirements recited
in claim 12. PO Resp. 14–20; see Ex. 2021 ¶¶ 30–33. In particular, Patent
Owner asserts that Deramond’s 15-gauge needle is 5 cm – 7 cm in length,
while Deramond’s 10-gauge needle is 10 cm – 15 cm in length, and, thus,
the 15-gauge needle (alleged nozzle instrument) cannot serve as a tamping
instrument (in combination with the stylet) to urge residual material from the
10–gauge needle (alleged subcutaneous cannula), as required by the claim.
PO Resp. 17; see Ex. 2021 ¶ 30 (citing Ex. 1003, 2). Further, Patent Owner
argues that the outer diameter of the 15-gauge needle is 1.829 mm, while the
inner diameter of the 10-gauge needle is 2.692 mm, allowing for the
existence of a space between the needles. PO Resp. 18; see Ex. 2021 ¶¶ 31–
32. Patent Owner argues:
Even assuming for the sake of argument that a stylet occupied
the entire internal space of a 15-gauge needle as well as
extended beyond the 15-gauge needle and beyond the 10-gauge
needle, the space between the 10-gauge and 15-needles would
remain. [Ex. 2021 ¶¶ 31–34]. If material such as
[polymethylmethacrylate (PMMA) bone cement] were
delivered through the 15-gauge needle, the material would leak
into the space between the 10- and 15-gauge needles. Id. Thus,
the 15-gauge needle together with the stylet could not be used
as a tamp to effectively push material out of the 10-gauge
needle (cannula) because the material would back up into the
space between the 10-gauge needle and the 15-gauge needle. Id.

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PO Resp. 18. Patent Owner further argues that a person of ordinary skill
would not have used the co-axial arrangement for delivery of cement
because “the geometry of the 10-gauge and 15-gauge needles is such that
this arrangement is impossible.” Id. at 19.
Petitioner replies that Patent Owner’s “geometric” arguments are
incorrect. Pet. Reply 17–21. With respect to the length of the 15-gauge
needle depicted in Figure 4A of Deramond, Petitioner argues, and we agree,
that the 15-gauge needle is shown extending beyond the 10-gauge needle.
Id. at 17–18 (citing Ex. 1003, Fig. 4A; Ex. 1002 ¶ 64; Ex. 1041 ¶ 9). In
deposition, Patent Owner’s expert, Dr. Baroud, conceded this point.
Ex. 1040, 239:19–240:2. We are persuaded that Figure 4A depicts a
15-gauge needle that is longer than the 10-gauge needle.
With respect to the diameter of the 15-gauge needle, we agree with
Petitioner that claim 12 does not require “any particular level of tamping
‘effectiveness’ or that there be no space between the tamping instrument and
the subcutaneous cannula.” Pet. Reply 19. Further, Dr. Jensen testifies
persuasively that the residual material could be cleared from the cannula by
repeatedly pushing the tamping instrument (formed by combining the
15-gauge needle with the stylet) within the lumen of the 10-gauge needle.
Ex. 1041 ¶ 10.
Patent Owner also argues that the requirement for a delivery device
having a delivery pressure of “no greater than about 360 psi” is not met by
Deramond. PO Resp. 16. As discussed above, however, we are persuaded
that Deramond’s 2- and 3-cc luer-lock syringes, inherently, disclose the
“delivery device” limitation. See supra Section II.B.1. We also are
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persuaded that substituting a conventional syringe meeting the “delivery
device” limitation for Deramond’s 2- or 3-cc luer-lock syringe would have
amounted to the mere substitution of one element for another known in the
field, to yield predictable results. See supra Section II.C.1.
For the reasons given, we conclude that Petitioner has shown, by a
preponderance of the evidence, that claim 12 would have been obvious over
Deramond.
3. Claim 15
To support its challenge of claim 15 as obvious over Deramond,
Petitioner relies upon its anticipation analysis, discussed above. Pet. 21; see
supra Section II.B. We agree with Petitioner’s argument that the “delivery
device” limitation would have been obvious to a skilled artisan:
[I]t would have been obvious to select “a delivery device to
convey the material at a pressure no greater than about 360 psi”
(which the 734 patent describes as a “conventional syringe”)
since the use of such devices at such pressures were well known
in the art and the skilled artisan would be motivated to select,
and would prefer, such pressures for controlled delivery of
cement. (Jensen Decl. at ¶¶ 39, 40, 69 n. 5, 164, 165; see also
footnote 6.)

Pet. 21.
Patent Owner responds that the requirement for a delivery device
having a delivery pressure of “no greater than about 360 psi” is not met by
Deramond. PO Resp. 16. As discussed above, however, we are persuaded
that Deramond’s 2- and 3-cc luer-lock syringes, inherently, disclose the
“delivery device” limitation. See supra Section II.B.1. We also are
persuaded that substituting a conventional syringe meeting the “delivery
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device” limitation for Deramond’s 2- or 3-cc luer-lock syringe would have
amounted to the mere substitution of one element for another known in the
field, to yield predictable results. See supra Section II.C.1.
For the reasons given, we conclude that Petitioner has shown, by a
preponderance of the evidence, that claim 15 would have been obvious over
Deramond.
4. Claims 2–11, 13, 14, and 16–21
Patent Owner presents arguments only as to independent claims 1, 12,
and 15 and relies on those arguments as to dependent claims 2–11, 13, 14,
and 16–21. PO Resp. 20. Dr. Jensen’s testimony supports Petitioner’s
contention that the dependent claims would have been obvious over
Deramond. Ex. 1002 ¶¶ 73–92. For the reasons set forth in the Petition and
the Decision to Institute, we conclude that Petitioner has shown, by a
preponderance of the evidence, that claims 2–11, 13, 14, and 16–21 would
have been obvious over Deramond. See Pet. 21–27; Dec. 15–16.
D. Obviousness of Claim 12 over Kuslich
Petitioner challenges claim 12 as obvious over Kuslich in view of the
knowledge of a person of ordinary skill in the art. Pet. 56–60. As discussed
above, claim 12 requires, inter alia, a “nozzle bore through which the
material conveyed by the delivery device enters bone at the delivery
pressure,” a “stylet capable of advancement into the nozzle bore through the
proximal fitting to close the nozzle bore,” and a “tamping instrument”
(formed by combining the nozzle instrument with the stylet) to urge residual
material from the subcutaneous cannula. Ex. 1001, 20:48–55.
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Kuslich discloses boring a cavity through a disc and the adjoining
vertebrae, inserting expandable bag 40 into the cavity through guide tube 54,
and then filling bag 40 with graft medium or fill material. Ex. 1009, Fig. 5,
8:3–11, 9:10–12, 62–63. Kuslich also discloses using gun-like device 90
with plunger 96 to inject graft material from a cartridge into bag 40.
Ex. 1009, 10:19–36. Figures 34 and 35 of Kuslich are reproduced below.

Figure 34 depicts using the gun-like device to fill the bag, and
Figure 35 depicts a cross-section of the end of the device. Id. at 5:30–32.
As shown in Figure 35, the bag includes a threaded fill port with internal
threads 82 to receive threaded screw 84. Id. at 10:20–22. Plunger 96 pushes
screw 84 along with the graft material towards bag 40 and, at the end of the
stroke, turns the screw to seal the bag. Id. at 10:31–34.
According to Petitioner, Kuslich discloses all the limitations of
claim 12 except it does not specify any particular delivery pressure for
device 90. Pet. 57; see id. at 59–60; Ex. 1002 ¶ 166. As discussed below,
we are not persuaded that Kuslich discloses or suggests a “tamping
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instrument,” formed by combining the nozzle instrument with the stylet, to
urge residual material from the subcutaneous cannula, as the claim requires.
Petitioner asserts that guide tube 54 is a “subcutaneous cannula,” the
barrel of Kuslich’s gun-like device 90 is a “nozzle,” and “plunger 96 is a
stylet that is advanced through the nozzle, closing the nozzle bore.” Pet. 59–
60. Nowhere does Petitioner even assert, however, that plunger 96 and the
barrel of device 90 are capable of use, together, as a tamping instrument to
urge residual material from guide tube 54, as required by claim 12. See Pet.
57–60; Pet. Reply 21–24; Ex. 1002 ¶ 166; Ex. 1041 ¶¶ 12–14.
Moreover, Patent Owner argues persuasively that residual materials
do not accumulate in Kuslich’s guide tube 54. PO Resp. 24 (citing
Ex. 1009, Fig. 21). Patent Owner asserts: “After extrusion of the bag, there
are no residual materials left in the delivery tube device. The plunger . . .
empties all graft materials into the bag.” Id. Patent Owner’s argument is
consistent with Kuslich’s teaching to insert the unexpanded bag into the
cavity before injecting the graft materials into the bag. E.g., Ex. 1009, 12:5–
27. As such, materials would not leak from the bag into the guide tube 54.
Petitioner has not addressed this argument, or otherwise shown how residual
materials would accumulate in Kuslich’s guide tube 54, or, if they did, why
or how they should be expelled. Pet. Reply 21–24; Ex. 1041 ¶¶ 12–14; see
Pet. 57–60; Ex. 1002 ¶ 166.
For the reasons given, we conclude that Petitioner has not
shown, by a preponderance of the evidence, that claim 12 would have
been obvious over Kuslich.
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III. CONCLUSION
For the foregoing reasons, we determine that Petitioner has
shown, by a preponderance of the evidence, that claims 15, 16, 19,
and 20 are unpatentable under 35 U.S.C. § 102(b) as anticipated by
Deramond and claims 1–21 are unpatentable under 35 U.S.C. § 103(a)
as obvious over Deramond. We further determine that Petitioner has
not shown, by a preponderance of the evidence, that claim 12 is
unpatentable under 35 U.S.C. § 103(a) as obvious over Kuslich.
IV. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that claims 1–21 of U.S. Patent No. 6,241,734 B1 are
unpatentable.
This is a Final Written Decision. Parties to the proceeding seeking
judicial review of the decision must comply with the notice and service
requirements of 37 C.F.R. § 90.2.

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For Petitioner:

Sandra A. Frantzen
sfrantzen@mcandrews-ip.com

Deborah A. Laughton
dlaughton@mcandrews-ip.com

Robert F. Kappers
rkappers@mcandrews-ip.com

For Patent Owner:

Tarek N. Fahmi
tarek.fahmi@ascendalaw.com

Michael A. Davitz
michael.davitz@ascendalaw.com