Medtronic, Inc.v.Mark Barry

Patent Trial and Appeal Board

Feb 10, 2015

11027026 (P.T.A.B. Feb. 10, 2015)

Trials@uspto.gov
571-272-7822
Paper 10
Date Entered: February 10, 2015

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

MEDTRONIC, INC.,
Petitioner,

v.

MARK A. BARRY,
Patent Owner.
____________

Case IPR2014-01210
Patent 7,670,358 B2
____________

Before DONNA M. PRAISS, BRIAN J. McNAMARA, and
JEREMY M. PLENZLER, Administrative Patent Judges.

McNAMARA, Administrative Patent Judge.

DECISION
Denying Institution of Inter Partes Review
37 C.F.R. § 42.108

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BACKGROUND
Medtronic, Inc. (“Petitioner”) filed a Petition, Paper 2 (“Pet.”), to institute
an inter partes review of claims 1–5 (the “challenged claims”) of U.S. Patent No.
7,670,358 B2 (“the ’358 Patent”). 35 U.S.C. § 311. Mark A. Barry (“Patent
Owner”) did not file a Preliminary Response. We conclude that Petitioner has not
shown, under 35 U.S.C. § 314(a), that there is a reasonable likelihood that it would
prevail with respect to at least one of the challenged claims.
For the reasons described below, we do not institute an inter partes review.
PENDING LITIGATION
Petitioner is the defendant in litigation concerning the ’358 Patent, Mark A
Barry, MD v. Medtronic, Inc., filed in the Eastern District of Texas as Case No.
1:14-cv-00104-RC on February 18, 2014. Petitioner was served with the
complaint on February 20, 2014. Pet. 1.
OTHER RELATED MATTERS
Two additional, related patents are the subject of concurrent petitions for
inter partes review by Petitioner Medtronic, Inc.: Patent No. 8,361,121 (Case IPR
2014-01211) and Patent No. 7,776,072 (Case IPR 2014-01212).
THE ’358 PATENT (EXHIBIT 1020)
The ’358 Patent discloses a system for ameliorating aberrant spinal column
deviation conditions, such as scoliosis, that facilitates the application of
derotational forces to individual vertebrae, while reducing the risk of fracture when
applying such forces. Ex. 1020, col. 3, ll. 15–25. The system includes a number
of bone screws that are implanted into the pedicle region(s) of individual vertebrae
to be rotated, and to vertebrae to which balancing forces must be applied, as the
spinal column is manipulated en masse to achieve an overall correction. Id. at col.
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3, ll. 37–43. The pedicle screws have a threaded shank segment and a head
segment. Id. at col. 4, ll. 59–60. The head segment has a spinal rod conduit (or
channel) that interfaces with a pre-contoured spinal rod. Id. at col. 4, ll. 61–62;
col. 5, ll. 47–48. A spinal rod engagement means is tightened, using known anti-
torque techniques, to fix the pedicle screw and spinal rod in relative position and
orientation, once a spinal column derotation is complete. Id. at col. 4, ll. 63–65;
col. 5, ll. 48–59.
The system also includes pedicle screw cluster derotation tools. The pedicle
screw cluster derotation tool facilitates simultaneous application of manipulative
forces to multiple pedicle screws implanted in a like number of vertebrae (a
“cluster”). Id. at col. 5, ll. 25–29. The derotation tool includes shafts, extending
from a common handle or linked handle array, that extend to and engage the heads
of a number of pedicle screws implanted in adjacent vertebrae to which
derotational or balancing forces are to be applied during a spinal column derotation
and alignment. Id. at col. 3, ll. 48–54. As manipulative forces are applied to the
handle means of the pedicle screw cluster derotation tool, forces are transferred
and dispersed simultaneously among the engaged vertebrae so that a practitioner
may, in a single motion, simultaneously and safely derotate multiple vertebrae of
an affected spinal segment and apply balancing forces to other group(s) of
vertebrae which are contiguous to the effected segment(s). Id. at col. 3, ll. 54–63.
Each pedicle screw cluster derotation tool is configured from a grouping of
pedicle screw wrenches joined together by pedicle screw wrench linking members
to act in unison when used to effect rotation or apply a balancing force. Id. at col.
4, l. 66–col. 5, l. 6. Each pedicle screw wrench includes a handle, a shaft, and a
distal end that reversibly engages the head segment of a pedicle screw. Id. at col.
5, ll. 32–34. As the shaft is moved while the distal end is engaged with a head
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segment of a pedicle screw, manipulative forces are transferred to the pedicle
screw and, in turn, to the vertebra in which that pedicle screw is implanted. Id. at
col. 5, ll. 12–18. Ordinarily, two derotation tools will be involved on either side of
the spinal column, with two pedicle screws being implanted in each vertebra. Id. at
col. 5, ll. 7–9. Wrench cross-linking members are used to coordinate forces
applied to screw clusters on either side of the spinal column. Id. at col. 5, ll. 9–11.
ILLUSTRATIVE CLAIM
1. A method for aligning vertebrae in the amelioration of
aberrant spinal column deviation conditions comprising the
steps of:
selecting a first set of pedicle screws, said pedicle screws
each having a threaded shank segment and a head segment;
selecting a first pedicle screw cluster derotation tool, said first
pedicle screw cluster derotation tool having first handle
means and a first group of pedicle screw engagement
members which are mechanically linked with said first
handle means, each pedicle screw engagement member
being configured for engaging with, and transmitting
manipulative forces applied to said first handle means to
said head segment of each pedicle screw of said first set of
pedicle screws,
implanting a each [sic] pedicle screw in a pedicle region of
each of a first group of multiple vertebrae of a spinal
column which exhibits an aberrant spinal column deviation
condition;
engaging each pedicle screw engagement member respectively
with said head segment of each pedicle screw of said first
set of pedicle screws; and
applying manipulative force to said first handle means in a
manner for simultaneously engaging said first group of
pedicle screw engagement members and first set of pedicle
screws and thereby in a single motion simultaneously
rotating said vertebrae of said first group of multiple
vertebrae in which said pedicle screws are implanted to
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achieve an amelioration of an aberrant spinal column
deviation condition;
selecting a first length of a spinal rod member; wherein one or
more of said pedicle screws of said first set of pedicle
screws each includes:
a spinal rod conduit formed substantially transverse of the
length of said pedicle screw and sized and shaped for
receiving passage of said spinal rod member there-
through; and
spinal rod engagement means for securing said pedicle
screw and said spinal rod member, when extending
through said spinal rod conduit, in a substantially fixed
relative position and orientation;
extending said first length of said spinal rod member through
said spinal rod conduits of one or more of said pedicle
screws of said first set of pedicle screws; and
after applying said manipulative force to said first handle
means, actuating said spinal rod engagement means to
secure said vertebrae in their respective and relative
positions and orientations as achieved through application
of said manipulative force thereto.
BASIS OF PETITION
Petitioner purports to present seven challenge grounds to the claims of the
’358 Patent. Pet. 2–3. However, the Petition discusses only six challenge grounds.
Pet. 10, 21, 28, 37, 43, and 57. There appears to be no discussion of the challenge
to claims 2–5 as obvious over the ’928 Appl.
1
in view of MTOS
2
and the ’349
Patent,
3
identified in the table on page 3 of the Petition as Ground 5. The

1
U.S. Patent Application Publication No. 2005/0245928 A1, published Nov. 3,
2005. Ex. 1006 (“the ’928 Appl.)
2
Anthony S. Rinella, Yongjung J. Kim, and Lawrence G. Lenke, “Posterior Spinal
Instrumentation Techniques for Spinal Deformity in Masters Techniques,” Chapter
17 in Orthopaedic Surgery: The Spine, 2nd Edition (undated; see Declaration of
Dr. Lawrence Lenke, Ex. 1001 ¶43, asserting publication date of Nov. 13, 2003.).
Ex. 1012 (“MTOS”)
3
U.S. Patent No. 5,219,349, issued June 15, 1993. Ex. 1005 (“the ’349 Patent”).
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discussion of Ground 5, beginning at page 43 of the Petition appears to correspond
to Ground 6 in the table at pages 2–3. The discussion of Ground 6 beginning at
page 57 of the Petition appears to refer to Ground 7 in the table at pages 2–3.
In addition, the Petition identifies as a single ground, several grounds that
include alternative combinations of references. For example, the Petition identifies
as a single ground challenges under § 102 and § 103. Pet. 2. In another example,
the Petition identifies as a single ground (Ground 6) its challenge that claims 1–5
are “Obvious under § 103 by the Video
4
, the Slides
5
, and/or MTOS (alone or in
combination) in view of the ’928 Appl.” (emphasis added). Pet. 3. Challenges
framed this way constitute multiple, separate grounds.
In addition, the challenges discussed in the Petition do not conform to the
challenges articulated in the table on pages 2 and 3 of the Petition. For example,
the table identifies Ground 4 as “Obvious under § 103 by the ’928 Appl. in view of
the Thoracic Pedicle Screws for Idiopathic Scoliosis Video (the ‘Video’) and Free
Hand Thoracic Screw Placement and Clinical Use in Scoliosis and Kyphosis
Surgery slide handout (the ‘Slides’).” Thus, the table states that Ground 4 is a
challenge based on the combination of three references, i.e., the ’928 Appl., the
Video, and the Slides. However, the heading to the discussion on page 37 of the
Petition describes this challenge as “Claims 1-5 are Obvious Under 35 U.S.C.
§ 103 Over the ‘928 Appl. in view of the Video and/or Slides.” Pet. 37. This
language indicates that the claims are challenged as obvious over any of the
following combinations: (1) the ’928 Appl. and the Video; (2) the ’928 Appl. and
the Slides; (3) the ’928 Appl. and the Video and the Slides.

4
Thoracic Pedicle Screws for Idiopathic Scoliosis Video (2001). Ex. 1002
(“Video”)
5
Free Hand Thoracic Screw Placement and Clinical Use in Scoliosis and
Kyphosis Surgery slide presentation handout (2003). Ex. 1003 (“Slides”)
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The challenge Petitioner identifies as Ground 6 in the table, discussed as
Ground 5 on page 43 of the Petition, also is confusing. The table states that claims
1–5 are challenged as “Obvious under § 103 by the Video, the Slides, and/or
MTOS (alone or in combination) in view of the ‘928 Appl.” The heading at page
43 identifies this challenge as “Claims 1-5 are Obvious Under 35 U.S.C. § 103
Over the Video, the Slides, and/or the MTOS Chapter in view of the ’928 Appl.”
Pet. 43. It is unclear if the challenge means that the MTOS is an alternative to the
Slides or to both the Video and Slides.
A similar problem exists with the challenge Petitioner identifies as Ground 7
in the table and discusses as Ground 6 at page 57. The table at page 3 identifies the
challenge as “Obvious under § 103 by the Video, the Slides, and/or MTOS (alone
or in combination) in view of U.S. 2003/0065328 (“the ’328 Appl.”).
6
Pet. 3. The
heading at page 57 states the challenge as “Claims 1-5 are Obvious Under 35
U.S.C. § 103 Over the Video, the Slides, and/or the MTOS chapter in view of the
‘328 Appl.” Pet. 57. Once again it is unclear if the challenge means that the
MTOS is an alternative to the Slides or to both the Video and Slides.
We summarize the challenges, as presented by Petitioner, in the following
table:
CLAIMS STATUTORY BASIS GROUND
1–5 §102/§103
Anticipated by or obvious
over ’349 Patent (Pet. 2,
Ground 1)
1 §102/§103
Anticipated by or obvious
over ’928 Appl. (See Pet.
2, Ground 2)

6
U.S. Patent Application Publication No. 2003/0065328A1, published Apr. 3,
2003. Ex. 1004 (’328 Appl.”).
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1–5 §103
Obvious over ’928 Appl.
in view of MTOS (Pet. 2,
Ground 3)
1–5 §103
Obvious over ’928 Appl.
in view of Video and
Slides (Pet. 3, Ground 4;
see id. at 37, where the
identification of Ground 4
differs from the grounds
in the table on page 3 of
the Petition)
2–5

§103
Obvious over
combination of ’928
Appl., MTOS, and ’349
Patent. (Pet. 3, Ground 5).
This ground is not
discussed further in the
Petition.
1–5 §103
Obvious over
combination of the
Video, the Slides and/or
MTOS(alone or in
combination) in view of
’928 Appl. (Pet. 3,
Ground 6; id. at 43,
Ground 5)
1–5 §103
Obvious over the
combination of the Video,
the Slides, and/or MTOS
(alone or in combination)
in view of the ’328 Appl.
(Pet. 3, Ground 7; id. at
57, Ground 6)
CLAIM CONSTRUCTION
In an inter partes review, claim terms in an unexpired patent are interpreted
according to their broadest reasonable construction in light of the specification of
the patent in which they appear. 37 C.F.R. § 42.100(b); Office Patent Trial
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Practice Guide, 77 Fed. Reg. 48756, 48766 (Aug. 14, 2012). Claim terms are
given their 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 words of the claim must be
given their plain meaning unless the plain meaning is inconsistent with the
specification. In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989). Any special
definition for a claim term must be set forth in the specification with reasonable
clarity, deliberateness, and precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir.
1994).
While reserving the right to challenge the claims as indefinite in the district
court, for purposes of this inter partes review, Petitioner proposes specific
constructions for the following terms:
Spinal rod engagement means (claims 1 and 3). Petitioner contends that this
term is not a “means-plus-function” term under 35 U.S.C. § 112 ¶6, and that the
term should be given its ordinary meaning as “a structure for contacting or
interfacing with a spinal rod.” Pet. 4. According to Petitioner, if we determine that
“spinal rod engagement means” is a mean plus function term, we should construe
the function to be “securing a screw to a spinal rod” and the corresponding
structure to be “a structure forming at least a portion of a passageway for receiving
a rod for performing the claimed function.” Pet. 4–5.
On its face, the relevant portion of claim 1 is written in means-plus-function
form, reciting “spinal rod engagement means for securing said pedicle screw and
said spinal rod member, when extending through said spinal rod conduit, in a
substantially fixed relative position and orientation.” Ex. 1020, col. 6, ll. 45-48
(Emphasis added). The function recited in the claim is securing the pedicle screw
and spinal rod member in a substantially fixed relative position and orientation.
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The recited function is consistent with the ’358 Specification, which states that the
“[s]pinal rod engagement means 20 serve to fix the pedicle screw 10 and spinal rod
18 in relative position and orientation, once a spinal column derotation is
complete.” Ex. 1020, col. 2, ll. 63–64. The Specification further explains that the
spinal rod engagement means is tightened using known anti-torque techniques to
fix the pedicle screw and spinal rod in relative position and orientation to secure
the corrected spinal column configuration. Id. at col. 5, ll. 48–59. As explained at
column 2, lines 59–65, and column 5, lines 54–59 of the ’358 Patent, the
corresponding structure is that portion 20 of pedicle screw 10 illustrated in Figure
4 that can be tightened to secure the spinal rod and pedicle screw. Therefore, we
construe the spinal rod engagement means to mean the portion of the pedicle screw
that can be tightened to secure the pedicle screw and spinal rod in a substantially
fixed position and orientation.
Handle means (claims 1 and 2). Petitioner contends that this term is not a
means-plus-function term and should be construed consistent with the dictionary
definition to mean “a part that is designed especially to be grasped by the hand or
that may be grasped by the hand.” Pet. 5. If we do construe the term as a means-
plus-function term, Petitioner proposes that the claimed function is “facilitating
simultaneous application of manipulative forces to a first/second group of pedicle
screw engagement members, and simultaneously moving each associated pedicle”
and the corresponding structure is “a handle from which shafts extend or linked
handles. Id. Claim 1 recites the first pedicle screw cluster derotation tool as
having a first handle means. Ex. 1020, col. 6, ll. 14–15. We agree with Petitioner
that claim 1 recites the “handle means” as a structure and not as a means-plus-
function recitation. Claim 1 does not recite a handle means for performing some
function. The Specification states that manipulative forces are applied to the
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handle means of the pedicle screw derotation tool. Id. at col. 3, ll. 56–57. Thus,
the “handle means” is a structure. We further agree, generally, with Petitioner’s
proposed construction based on the dictionary definition of handle. We construe
the “handle means” to mean a part that is designed especially to be grasped by the
hand, but do not agree that the handle means includes any part that may be grasped
by the hand.
Mechanically linked (claims 1 and 2). Petitioner contends that the broadest
reasonable construction of mechanically linked is “joined by a physical connection
or physically joined.” Pet. 5–6. Claim 1 recites that a first group of pedicle screw
engagement members “are mechanically linked with said first handle means.” Ex.
1020, col. 6, ll. 17–18. The term “mechanically linked” is not used in the
Specification. We agree with Petitioner that in the context of the ’358 Patent, the
broadest reasonable construction of “mechanically linked” is joined by a physical
connection.
A second group of multiple vertebrae. Although Petitioner refers to this
term as appearing in claim 4, Pet. 6, it appears in claims 2 and 3, but not in claim 4.
Petitioner proposes that, under the broadest reasonable construction, the “second
group of multiple vertebrae” means “multiple vertebrae located at least in part at a
different location on the spine than the first group of vertebrae.” Pet. 6. Claim 2
depends from claim 1 and recites additional steps, including selecting a second set
of pedicle screws and implanting each pedicle screw in a pedicle region of each of
a second group of multiple vertebrae of a spinal column. Petitioner has not
identified any description in the Specification to support its proposed construction
limiting the location of second group of multiple vertebrae at least in part to a
different location on the spine. For example, Petitioner does not point to any
description that would preclude the second set of multiple vertebrae from being a
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subset of the first set of multiple vertebrae. Therefore, we decline to adopt
Petitioner’s proposed construction limiting this term. We need not construe the
term further.
ANALYSIS OF PETITIONER’S PRIOR ART CHALLENGES
Anticipation and obviousness of claims 1–5 based on the ’349 Patent
To prevail in its challenges to the patentability of the claims, Petitioner must
establish facts supporting its challenges by a preponderance of the evidence. 35
U.S.C. § 316(e); 37 C.F.R. § 42.1(d). Petitioner contends that claims 1–5 of the
’358 Patent are anticipated by the disclosures in the ’349 Patent. A claim is
unpatentable under 35 U.S.C. § 102 if a prior art reference discloses every
limitation of the claimed invention, either explicitly or inherently. Glaxo Inc. v.
Novopharm Ltd., 52 F.3d 1043, 1047 (Fed. Cir.1995); see MEHL/Biophile Int’l
Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed.Cir.1999) (“To anticipate, a single
reference must teach every limitation of the claimed invention”; any limitation not
explicitly taught must be inherently taught and would be so understood by a person
experienced in the field).
We are persuaded by Petitioner’s argument that the ’349 Patent (Ex. 1005)
discloses a method for aligning vertebrae in the ameliorating of aberrant spinal
column deviation conditions, as recited in the preamble of claim 1 (Claim 1[A])
7
of
the ’358 Patent. The ’349 Patent (Ex. 1005) discloses a spinal fixator reduction
frame that seeks to distribute applied forces evenly across screws and pedicles to
which it attaches, Ex. 1005, col. 2, ll. 49–52, and to control and produce
flexation/extension, lateral bending, axial rotation, distraction/compression,
anterior/posterior shear, and lateral shear, id. at col. 2, ll. 57–61. Shaft clamp
assemblies, each having one translational and three rotational degrees of motion,

7
For convenience, we use Petitioner’s claim element designations.
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secure the reduction frame to shaft handles extending from the pedicle screws of a
fixator device. Id. at col. 2, l. 67–col. 3, l. 4. Referring to Figures 2 and 3 of the
’349 Patent, each reduction frame 50 includes two T-handles 100, which can be
used alone or with one or both of lower rod assembly 200 and upper rod assembly
300. Id. at col. 4, ll. 3–16. The shaft clamp assemblies secure two T-handles to the
shaft handles, so that each T-handle may be grasped by hand to apply forces to the
spine. Id. at col. 3, ll. 4–9. “The T-handles function as handles to allow
manipulation of the spine with an even distribution of force between opposite
pedicles, in order to prevent the application of excessive load to either pedicle.”
Id. at col. 3, ll. 37–40.
As discussed above, the ’349 Patent discloses pedicle screws. Below is a
reproduction of Figure 1 of the ’349 Patent, annotated to identify the pedicle
screws and related structures Petitioner contends correspond to those recited in
claim 1 of the ’358 Patent.

Figure 1 of the ’349 Patent (annotated)
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We are persuaded that the description at column 1, lines 25–30 of the ’349
Patent of drilling holes and screwing pedicle screws on either side of the vertebrae
discloses that the pedicle screws are implanted as recited in Claim 1[D] and that
the pedicle screws in the ’349 Patent each have a threaded shank and head
segment, as recited in Claim 1[B]. Pet. 13, citing Ex. 1005, col. 4, ll. 36–39 and
Fig. 1.
Petitioner argues that the ’349 Patent discloses a first pedicle screw cluster
derotation tool, as recited in claim 1. Figure 2 below is a reproduction of Figure 2
of the ’349 Patent annotated to identify the structures Petitioner contends
correspond to the derotation tool and related structures recited in claim 2 of the
’358 Patent.

Figure 2 of the ’349 Patent (annotated)
Petitioner states that the derotation tool in the ’349 Patent discloses the
claimed first handle means in the “form of hinged extensions 136, portions of
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laterally extending arms 112, the lower portions of dorsally extending legs 110,
and threaded rod 210 that connects the portions of dorsally extending legs 110.”
Pet. 11. Petitioner explains that the first group of pedicle screw engagement
members, in the form of shafts 14 of the ’349 Patent mechanically link (or join by
a physical connection, as we have construed that term) the pedicle screws 12 to the
first handle means (136, 112, 110, and 210) and that, because of this rigid
mechanical link, any force applied to the handle means is transferred to the shafts
and subsequently to head segment of the pedicle screw engaged with the shaft, as
recited in Claim 1[C] of the ’358 Patent. Id. Petitioner further cites the description
in the ’349 Patent of placing pedicle screws into place using shaft handle 14
attached to flats on the top of each screw as disclosing the claimed feature of
engaging each pedicle screw engagement member respectively with a head
segment of a pedicle screw recited in Claim 1[E].
Along the lines proposed by Petitioner, we have construed the term “handle
means” to mean a part that is designed especially to be grasped by hand. Petitioner
has not identified any disclosure in the ’349 Patent of a part that is designed to be
grasped by hand. Thus, Petitioner has not persuaded us that the ’349 Patent
discloses a handle means as recited in Claim 1[C] or as recited in Claim 1[E],
which recites “applying manipulative force to said first handle means [a part that
can be grasped by hand] in a manner for simultaneously engaging said first group
of pedicle screw engagement members and first set of pedicle screws and thereby
in a single motion simultaneously rotating said vertebrae of said first group of
multiple vertebrae in which said pedicle screws are implanted.” Thus, we are not
persuaded that Petitioner has demonstrated a reasonable likelihood of prevailing in
demonstrating that claim 1, or that claims 2–5, which depend directly or indirectly
from claim 1, are anticipated or obvious over the ’349 Patent.
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Anticipation and Obviousness of Claim 1 Based on the ’928 Application
The ’928 Appl. discloses a displacement device for the displacement of bony
structures, such as vertebrae of the spine, relative to each other. Ex. 1006 ¶ 8. The
displacement device has at least two guide members connected by cross members.
Ex. 1006 ¶ 24. The guide members are displaced relative to each other responsive
to manipulation of a user interface. Id. The guide members provide for the
transmission of distraction or compression force percutaneously to bony structures
thus allowing compression or distraction of the bony structures. Id. The ’928
Appl. also discloses that the displacement device can be used to ensure correct
positioning of an implantable stabilization device, such as a brace connected
between pedicle screws anchored to the bony structures. Id. at ¶ 26. Thus we are
persuaded that the ’928 Appl. discloses Claim 1[A].
The figure below is a reproduction of Figure 9 of the ’928 Appl. annotated to
illustrate the pedicle screws and related structures described in the ’928 Appl. that
Petitioner contends correspond to elements of claim 1 of the ’358 Patent.
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Based on the illustrations in the annotated figure, we are persuaded by
Petitioner’s contention that the ’928 Appl. discloses pedicle screws having a
threaded shank segment and a head segment that can be implanted in multiple
vertebrae of a spinal column. Thus, we are persuaded that the ’928 Appl. discloses
Claim 1[B] and Claim 1[D].
The figure below is a reproduction of Figure 11 of the ’928 Appl. annotated
to identify structures described in the’928 Appl. that Petitioner contends
correspond to the derotation tool and related elements of claim 1 of the ’358
Patent.
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Turning to Claim 1[C], Petitioner identifies the first handle means as knobs
112a and 112b, which can be gripped by hand, and threaded rods 110b. Pet. 25.
Citing paragraph 43 of the ’928 Appl., Petitioner identifies the claimed pedicle
screw engagement members as guide tubes 102a, 102b, and 104, which are placed
over anchor extensions 606 and 607 and are mechanically linked (joined by a
physical connection) to the first handle means (knobs 112a and 112b and threaded
rod 110) by cross action members 106a,b and 107a,b by threaded rod coupling
108a. Id. We also note the presence of coupling 108b. Citing paragraph 55 of the
’928 Appl., Petitioner explains that when a pedicle screw engagement member is
moved by a force, the engagement member transfers that force to the pedicle
screws to provide direct compression or distraction, or can apply a force in a
direction perpendicular to the direction in which distraction or compression occurs.
Id. at 26. Thus, the pedicle screw engagement members are configured to engage
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with and transmit manipulative forces applied to the first handle means to the head
segment of the pedicle screws, as claimed. We are persuaded that Petitioner has
demonstrated that the ’928 Appl. discloses Claims 1[C] and 1[E].
Claim 1[F] recites applying manipulative force to the first handle means and
in a single motion simultaneously rotating the vertebrae of the first group of
multiple vertebrae in which the pedicle screws are implanted. The ’928 Appl.
discloses that angular and lateral adjustment may be made using the displacement
device and that displacement may include compression, distraction or a
combination of compression and distraction. Ex. 1006 ¶ 55. Claim 1[F] recites
rotating the vertebrae. Petitioner argues that paragraph 55 of the ’928 Appl. meets
the rotating limitation in Claim 1[F] because paragraph 55 discloses an
embodiment in which the device may be used to apply force in a direction that is
perpendicular to the direction in which distraction of compression occur. Pet. 24,
Lenke Decl.
8
Ex. 1001 ¶ 77. However, neither the Petition nor the Lenke Decl.
explains why this disclosure in the ’928 Appl. describes simultaneously rotating
the vertebrae. Petitioner also does not explain how the ’928 Appl. describes “in a
single motion rotating the vertebrae.” In the embodiment described in Figure 11 of
the ’928 Appl., when knob 112b is turned, cross action members 106b and 107b
move, causing guide tubes 102b to be displaced by compression or distraction
relative to guide tube 104, which remains stationary. Ex. 1006 ¶ 66. Adjusting
knob 112a causes the same action with respect to guide tubes 102a and 104. Id.
Thus, the ’928 appl. describes displacing the vertebrae using separate motions.
Two motions, turning knob 112a and 112b, are required to simultaneously displace
the vertebrae. Although Petitioner defines the first handle means to include both
knobs 102a and 102b, in view of the need to adjust both knobs and we are not

8
Declaration of Lawrence G. Lenke, submitted July 25, 2014 (Ex. 1001).
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persuaded that Petitioner has established that the ’928 Appl. discloses “in a single
motion rotating said vertebrae” as recited in Claim 1[F].
In view of the above, we are not persuaded that Petitioner has demonstrated
a reasonable likelihood of succeeding in its challenge to claim 1 as anticipated by
or obvious over the ’928 Appl. However, we continue our analysis of the ’928
Appl. because in other challenges Petitioner cites the ’928 Appl. in combination
with other references.
Petitioner explains that the ’928 Appl. discloses a spinal rod member in the
form of brace 601, that the pedicle screws 602 and 603 include the claimed spinal
rod conduit in the form of assemblies 500 and 700, which have walls separated by
slots to receive the brace (spinal rod member), and that the set screw 701
corresponds to the claimed spinal rod engagement means. Pet. 27–28. As shown
in Figure 9 of the ’928 Appl., the rod extends through the conduits of one or more
of the pedicle screws. Petitioner cites paragraph 61 of the ’928 Appl. for its
description of locking each end of brace 601 (spinal rod) to maintain the desired
displacement. Pet. 28. Thus, we are persuaded that the ’928 Appl. discloses
limitations Claim 1[G], Claim 1[H], and Claim 1[I].
Having determined that Petitioner has not established it would be reasonably
likely to prevail in its challenge to claim 1 as anticipated or obvious over the ’928
Appl., we do not institute a trial on either of these grounds.
Claims 1–5 as Obvious over the ’928 Appl. in view of MTOS
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. Graham v.John Deere Co., 383 U.S. 1, 17–18 (1966). A claim is
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unpatentable 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 said subject matter pertains. KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 406 (2007). To establish obviousness of a claimed
invention, all the claim limitations must be taught or suggested by the prior art.
See CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003); In re
Royka, 490 F.2d 981, 985 (CCPA 1974). 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. KSR Int’l Co., 550 U.S. at
418. In that regard, for an obviousness analysis it can be important to identify a
reason that would have prompted one of skill in the art to combine prior art
elements in the way the claimed invention does. Id. However, a precise teaching
directed to the specific subject matter of a challenged claim is not necessary to
establish obviousness. Id. Rather, obviousness must be gauged in view of
common sense and the creativity of an ordinarily skilled artisan. Id. Petitioner’s
expert, Dr. Lenke, identifies one of ordinary skill as having an undergraduate
degree in Mechanical or Biomedical Engineering or the equivalent, and at least two
to three years of experience with fixation implants and methods and systems for
scoliosis or spinal deformity correction and the like, or a medical degree or the
equivalent, and at least two to three years of experience with fixation implants and
methods and systems for scoliosis or spinal deformity correction and the like, or an
equivalent amount of experience in medical device design, e.g. four years design
experience could replace an undergraduate degree. Ex. 1001 ¶ 32.
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Claim 1
In this challenge, Petitioner cites the ’928 Appl. as disclosing elements [A]–
[E] and [G]–[I] of claim 1. Pet. 29. Petitioner cites MTOS as disclosing element
[F]. Petitioner contends that MTOS “discloses a procedure in which multiple
levels of vertebrae are rotated simultaneously by the application of force to pedicle
screws by multiple pedicle screw engagement members.” Id. MTOS states that
the majority of the chapter concentrates on the advantages and techniques of using
pedicle screws in the thoracic and lumbar spine, with an emphasis on surgical
planning and decision making. Ex. 1012 at 231.
9
This discussion indicates that
MTOS is a reference in the relevant field of endeavor and that one of ordinary skill
would be motivated to combine the teachings of MTOS with the teachings of the
’928 Appl. In particular, the description of the Apical Vertebral Derotation (AVD)
maneuver in the MTOS states that previous maneuvers derotate the correcting rod
90 degrees and translate the spine without much derotation. Id. at 242. In the
MTOS AVD maneuver, correcting posts are placed on each of four screws on the
concave and convex sides of the apex of the curve. Id. In the first maneuver,
derotation and downward pressure is accomplished by the convex side screws, as
shown in Figure 17-11. Id. at 242–245. The surgeon then places a previously
contoured rod, inserts set screws, and tightens all but the screws on the derotation
vertebrae and one additional level proximally and distally. Id. at 245. After
putting the rod in place, the surgeon performs the AVD maneuver on the concave
side and tightens the set screws. Id.
Petitioner contends that MTOS discloses applying manipulative force to a
group of handles that are grasped by a surgeon in a manner for simultaneously

9
For consistency with the Petition, we cite to the page numbers of the published
MTOS chapter, rather the page numbers of Ex. 1012.
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engaging a first group of pedicle screw engagement members and a first set of
pedicle screws, thereby in a single motion simultaneously rotating the vertebrae of
the first group of multiple vertebrae. Pet. 30. Petitioner does not explain how this
feature is combined with the disclosure in the ’928 Appl. to arrive at Claim 1[F].
Petitioner acknowledges that Fig. 17-11 discloses a “group of handles that are
grasped by the surgeon.” Id. (Emphasis added). At the lower left, Fig. 17-11 shows
at least four pedicle screw engagement members, but does not show a first handle
that is manipulated in a manner to simultaneously engage the first group of pedicle
screws and thereby in a single motion rotate the vertebrae. As previously
discussed, Petitioner described the knobs and threaded member in the ’928 Appl.
as disclosing the first handle means. As we also previously discussed, the
discussion of Fig. 11 in the ’928 Appl. describes how the first handle and cross
members would be used to achieve compression or distraction and why the single
motion limitation is not disclosed in the ’928 Appl. Petitioner does not describe
how the first handle means of the ’928 Appl. would be used in conjunction with
the teachings of MTOS to rotate simultaneously in a single motion the vertebrae of
a group of multiple vertebrae. Thus, Petitioner has not demonstrated a reasonable
likelihood of succeeding in its challenge to claim 1 of the ’358 Patent based on the
’928 Appl. in view of MTOS.
Claims 2–5
Claims 2–5 all depend directly or indirectly from claim 1. Having not
demonstrated a reasonable likelihood of success in its challenge to claim 1 based
on the combination of the ’928 Appl. and MTOS, Petitioner has also not
demonstrated a reasonable likelihood of success in bringing the same challenge
against claims 2–5.
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In view of the above, we decline to institute a trial on Petitioner’s challenge
to claims 1–5 based on the ’928 Appl. in view of MTOS.

Claims 1–5 as obvious over the combination of ’928 Appl. in view of the Video
and/or the Slides
In this challenge, Petitioner cites the ’928 Appl. as disclosing elements [A]–
[E] and [G]–[I] of claim 1. Pet. 37. Petitioner cites the Video as disclosing a
procedure in which multiple levels of vertebrae are rotated simultaneously by the
application of force to pedicle screws by multiple pedicle screw engagement
members. Id. at 38. Petitioner does not cite to any particular portion of the Video
as disclosing Claim 1[F]. These features are not described in the Petition, nor does
this portion of the Petition reference testimony by Dr. Lenke to establish what this
portion of the Video demonstrates. In addition, Petitioner does not describe how
the derotation device in the Video would be combined with the teachings of the
’928 Appl. As we have previously discussed, the teachings of the ’928 Appl.
concern distraction and compression. Thus, Petitioner has not demonstrated a
reasonable likelihood of prevailing in this challenge to claim 1 and dependent
claims 2–5. Therefore, we do not institute a trial on the ground that claims 1–5 are
obvious over the ’928 Appl. in view of the Video.
In addressing the Slides, Petitioner proffers arguments similar to those in its
challenge based on the combination of the ’928 Appl. and the Video. Pet. 39.
Petitioner cites to paragraphs 80 and 81 of the Lenke Decl. Id. These paragraphs
of the Lenke Decl. do not describe how the derotation device in the Slides would
be combined with the teachings of the ’928 Appl. Therefore, Petitioner has not
demonstrated a reasonable likelihood of prevailing in this challenge to claim 1 and
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dependent claim 2–5 and we decline to institute a trial on the grounds that claims
1–5 are obvious over the ’928 Appl. in view of the Slides.
Claims 1–5 As Obvious over the Video, the Slides, and/or MTOS in view of ’982
Appl.
In this challenge, Petitioner applies references asserted in prior challenges
differently and provides a more detailed explanation of the combination. We are
persuaded by Petitioner’s assertion that the Video, Slides and the MTOS chapter
each shows a system and its use for treating and correcting deformities and injuries
of the spine, as recited in Claim 1[A]. Pet. 44, 47. In particular, the Video shows a
surgeon implanting pedicle screws, each having a threaded shank and a head
segment into a group of multiple vertebrae of a patient’s spinal column, as recited
in Claim 1[B] and Claim 1[D] (id. at 48–49), engaging the head segment of the
pedicle screw members with engagement members (id. at 50) and applying force to
a group of handles in a single motion simultaneously rotating the vertebrae where
the single pedicle screws were implanted, to achieve the rotation recited in Claim
1[F] (id. at 50). We are further persuaded by Petitioner’s claim charts that the
Video shows the surgeon inserting a spinal rod into a conduit of one or more
pedicle screws and, after applying manipulative force, actuating the spinal rod
engagement means by locking the set bolts in position and tightening set screws, as
recited in Claim 1 elements [G], [H], and [I]. Id. at 51–52.
However, as discussed above, Claim 1[F] also recites that the manipulative
force is applied to a first handle means for simultaneously engaging the first group
of pedicle screws. We are not persuaded that any of the Video, the Slides and the
MTOS shows the manipulative force being applied to a first handle means because
they do not show a part that is designed especially to be grasped by the hand. The
Slides and MTOS show a group of members extending vertically from the pedicle
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screws, but do not show a first handle means for simultaneously engaging the
pedicle screws. The handles in the Video appear to have a vertically extending
portion and perpendicular members connected to the vertical members. Ex. 1002,
Part 7. When performing the AVD maneuver demonstrated in the Video, one of
the surgeon’s hands appears to grasp each vertical member separately, e.g., below
the perpendicular member on the left and the perpendicular member on the right.
Id.; see also Pet. 50, Claim Chart, Claim 1[C] (screen shots from Video showing
surgeon’s hands grasping vertical and perpendicular portions of handles). In the
Video, there is no handle means for simultaneously engaging the first group of
pedicle screws.
Petitioner argues that the ’928 Appl. discloses a pedicle screw cluster tool in
which multiple handles are linked together and cites the testimony of Dr. Lenke for
the proposition that the addition of a mechanical linking member to connect the
handles in the Video would be a simple and obvious modification in view of the
teachings of the ’928 Appl. and the design incentives of easing the surgeon’s
workload and achieving uniformity in the movement of the pedicle screw
engagement members. Pet. 46 (citing Ex. 1001 ¶¶ 67–68.)
10
As indicated in our
discussion of the ’928 Appl. above, we are not persuaded that Petitioner has
demonstrated a reasonable likelihood of prevailing in its challenge that the ’928
Appl. discloses “applying manipulative force to [the] first handle means [and] . . .
in a single motion simultaneously rotating [the] vertebrae of [the] first group of
multiple vertebrae in which the pedicle screws are implanted,” as recited in Claim
1[F]. The cited testimony of Dr. Lenke concerning mechanical linkage and the
teachings of the ’928 Appl. do not explain why one of ordinary skill would apply
such a linkage, which provides distraction and compression relative to a fixed

10
It appears that Petitioner intended to cite paragraphs 70–72 of the Lenke Decl.
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pedicle screw, in the context of the simultaneous rotation of a group of handles, as
shown in the Video, the Slides or MTOS. Thus, we are not persuaded that
Petitioner has demonstrated that the combination of these references renders
obvious the limitations of Claim 1[F]. Therefore, we are not persuaded that
Petitioner has demonstrated a reasonable likelihood of prevailing in its challenge to
claim 1 or to claims 2–5, which depend from claim 1, of the ’358 Patent based on
the Video, the Slides or the MTOS in view of the ’928 Appl. and we do not
institute a trial on this challenge.
Claims 1–5 As Obvious over the Video, the Slides and/or MTOS in view of the
’328 Appl.
Petitioner cites its analysis of Claim 1 elements [A]–[B] and [D]–[I] with
respect to the Video, Slides, and MTOS. Pet. 56. Petitioner contends that the
’328 Appl. discloses claim 1 element [C]. Petitioner contends that the ’328 Appl.
discloses
[A] system and method for the treatment of spinal column deviations
and discloses a pedicle screw cluster derotation tool having a first
handle means that includes individual handles – threaded rods 205 and
206, and threaded shank 222 of the connecting element 213 – linked
to three pedicle screw engagement members and a linking member, in
the form of a microschweller 204, to join together the handles.

Pet. 58. According to Petitioner, the ’328 Appl. provides that the linking of the
handles by the microschweller 204 facilitates simultaneous transport of the three
pedicle screw engagement members in the transverse plane. Id. (citing ’328 Appl.
¶ 87.) Citing the Lenke Decl., Petitioner argues that it would have been obvious to
one of ordinary skill in the art at the time of the invention to connect the individual
handles shown in the Video, the Slides, and the MTOS chapter via a mechanical
linkage to help ensure simultaneous and uniform transport of the pedicle screw
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engagement members while reducing the workload on the surgeon and that the
addition of a mechanical linking member to connect the handles and achieve the
same type of movement would have been nothing more than a simple and obvious
modification in view of the teachings of the ’328 Appl. Id. at 58 (citing Ex. 1001
¶¶ 67, 68.) Paragraphs 67 and 68 of the Lenke Decl. do not concern this subject
matter (it appears that Petitioner may have been referring to paragraphs 70 and 71
of the Lenke Decl.).
Paragraphs 83–85 of the ’328 Appl. explain the manipulation of distraction
rods in support units to correct the spine. Referring to Figures 11–13, paragraphs
86–87 of the ’328 Appl. explain that transverse adjustments can be achieved using
a microschweller 204 in which connecting post 213, fastened with the help of load
bearing nuts 209 and 210 is set in the longitudinal slot of the microschweller and
connected to the fixation junction 157 of an intermediate support unit. By
graduated turning of the load bearing nut 210, transport of the microschweller in
the transverse plane is performed. Load bearing nuts 207, 207a, 208, and 208a are
then fixed. Petitioner does not explain how this transverse motion, achieved by
adding a component to the support units, constitutes a first handle means of a
derotation tool, as recited in the claims or would be combined with the disclosures
in the Video, Slides, or MTOS. Therefore, we are not persuaded that Petitioner has
demonstrated a reasonable likelihood of success in demonstrating that claims 1–5
are unpatentable as obvious over the Video, the Slides and/or MTOS in view of the
’328 Appl. and we do not institute a trial on this challenge.
SUMMARY
We are not persuaded that Petitioner has demonstrated a reasonable
likelihood that it would prevail on any of the challenges in the Petition. Therefore,
do not authorize an inter partes review on any grounds.
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ORDER
In consideration of the foregoing, it is hereby:
ORDERED that the Petition is DENIED.

PETITIONER:
Jeff E. Schwartz
Seth A. Kramer
Fox Rothschild LLP
jeschartz@foxrothschild.com
skramer@foxrothschild.com

PATENT OWNER
David Henry
Michael Ellis
GRAY REED &McGRAW, P.C.
dhenry@grayreed.com
mellis@grayreed.com