Ex Parte Barrus

Patent Trial and Appeal Board

Jun 2, 2017

13675100 (P.T.A.B. Jun. 2, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/675,100 11/13/2012 Michael Barrus 1449-290 7248
31554 7590 06/06/2017
CARTER, DELUCA, FARRELL & SCHMIDT, LLP
445 BROAD HOLLOW ROAD
SUITE 420
MELVILLE, NY 11747
EXAMINER
COTRONEO, STEVEN J
ART UNIT PAPER NUMBER
3733
NOTIFICATION DATE DELIVERY MODE
06/06/2017 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
docket @ cdfslaw. com
tgiordano@cdfslaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL BARRUS1
Appeal 2016-003976
Application 13/675,100
Technology Center 3700
Before DONALD E. ADAMS, ERIC B. GRIMES, and JOHN G. NEW,
Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a spine
stabilization system, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
“Spinal fixation apparatuses are widely employed in surgical processes
for correcting spinal injuries and diseases.” (Spec. 1 5.) “In order to facilitate
stabilizing the spine and keeping the interbody in position, other implants are
commonly employed, such as bone screws and connecting rods.” {Id. 1 5.)
1 Appellant identifies the Real Party in Interest as K2M, Inc. (Br. 1.)
Appeal 2016-003976
Application 13/675,100
“[A] need exists for a simple and effective screw and rod construct that
enables surgeons to easily and safely manipulate the connecting rod relative to
the bone screws during a surgical procedure.” {Id. 1 6.)
The Specification discloses a spinal stabilization system that is said to
address this need. {Id. 129.) The components of the system are shown in
Figure 3, reproduced below:
Connecting rod 10 includes elongate rounded section 12 and elongate head
portion 14. {Id. 127.) Bone screw 50 includes slot 53, shank 54, and set
screw 60. {Id. 128.)
Claims 1—10 are on appeal. Claim 1 is the only independent claim
and reads as follows (emphasis added):
1. A spinal stabilization system comprising:
a connecting rod including an elongate rounded
section having a circular cross-section, an elongate head portion
having a non-circular cross-section, and a neck portion
connecting the elongate rounded section with the elongate head
portion, the connecting rod being monolithically formed; and
■50
FIG. 3
Figure 3 shows connecting rod 10 and bone screw 50. {Id. 124.)
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Appeal 2016-003976
Application 13/675,100
a bone screw including a head portion defining a
slot, a shank extending longitudinally from the head portion,
and a set screw configured to secure the connecting rod in the
slot, the slot including a leading end portion configured to
receive the elongate rounded section of the connecting rod and
a trailing end portion configured to threadably engage the set
screw, wherein the slot is flared such that elongate rounded
section of the connecting rod is pivotable about the leading end
portion of the slot.
DISCUSSION
The Examiner has rejected all of the claims on appeal under 35 U.S.C.
§ 103(a) as obvious based on Bergeron2 and Lake.3 (Ans. 2.) The Examiner
finds that Bergeron discloses a spinal stabilization system that meets all of
the limitations of claim 1 {id. at 2-4) “except for the rod being
monolithically formed” {id. at 5). The Examiner finds that Lake “discloses a
monolithic hour[glass] shaped rod.” {Id.) The Examiner concludes that it
would have been obvious “to make the rod of Bergeron et al. to be
monolithic in view of Lake et al. in order to have superior resistance to
bending,” as disclosed by Lake. {Id.)
Appellant argues that Bergeron teaches away from monolithically
forming its connecting rod because its system relies on moving a rod along a
wire until the rod reaches the appropriate bone fasteners:
[T]he Final Office Action’s proposed modification of Bergeron
to be monolithic as disclosed in Lake would render Bergeron
unsuitable for its intended purpose. . .. Such modification would,
in fact, inhibit, e.g., movement of rod 104 along wire 400 or
2 Bergeron et al., US 2011/0190823 Al, published Aug. 4, 2011.
3 Lake et al., US 2008/0086130 Al, published Apr. 10, 2008.
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Application 13/675,100
withdrawal of wire 400 while rod 104 is secured with bone
fastener assemblies 102.
(Br. 6.)
We agree with Appellant that the Examiner has not persuasively
shown that it would have been obvious to modify Bergeron’s system to
include a monolithically formed connecting rod/wire assembly. A
perspective view of Bergeron’s system is shown in its Figure 38, which is
reproduced below:
244
FIG. 38
Figure 38 shows an embodiment for placing a rod using wire 400.
(Bergeron 1144.) Bergeron states that “[vjarious surgical tools can be used
to position and move rod 104 [not labeled in Fig. 38] along wire 400,” which
enters the patient at incision I3 and exits the patient at incision I4. (Id.)
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Appeal 2016-003976
Application 13/675,100
The Examiner has provided an annotated version of Bergeron’s Figure
1, showing the elements of the claimed system identified by the Examiner:
mi
(Ans. 4.) Figure 1 shows “one embodiment of a portion of a spine
stabilization system, which comprises bone fastener assembly 102 and rod
104 (shown in a cross-sectional view).” (Bergeron 170.) Figure 1 also
includes “wire 400 (shown in a cross-sectional view in conjunction with rod
104).” (Id.)
The Examiner has annotated the figure to indicate that rod 104
corresponds to the “circular rounded section”—i.e., the “elongate rounded
section having a circular cross-section”—of the connecting rod recited in
claim 1. (Ans. 4.) The Examiner has also indicated that the bottom section
of wire 400 corresponds to the “non circular head portion”—i.e., the
“elongate head portion having a non-circular cross-section”—of the
connecting rod recited in claim 1. (Id.) We therefore understand that the
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Appeal 2016-003976
Application 13/675,100
Examiner finds that the limitations of the connecting rod of claim 1 are met
by the assembled rod and wire of Bergeron.
Bergeron discloses “systems and methods for spinal stabilization,
particularly systems and methods that utilize a wire having a non-circular
cross-sectional profile to deliver, preferably percutaneously, an elongated
member (e.g., a rod).” (Bergeron 14.) Bergeron’s system includes bone
fastener assemblies (e.g., bone screws (id. 176)), a rod, and a wire. (Id.
170.) “[W]ire 400 . . . is useful for the percutaneous advancement of rod
104 into the body and through collar 112 of bone fastener assembly 102 for
constructing a spine stabilization system.” (Id.)
Bergeron describes the use of its system as follows: two bone fastener
assemblies (and their associated sleeves) are positioned via two incisions,
after which “wire 400 can be inserted into a third incision I3 . . . [and]
advanced through openings 116” in the bone fastener assemblies, then out of
the patient through incision I4. (Id. 1144.) Then “rod 104 can be engaged to
wire 400” and “advance[d] along a path defined by wire 400” so that both
wire 400 and rod 104 pass through openings in the collars of the bone
fastener assemblies. (Id.) The “[r]od may be secured to bone fastener
assemblies 102, forming spine stabilization system 100.” (Id.)
After the rod has been secured to the bone fastener assemblies, “[w]ire
400 may be withdrawn from the third incision I3 or advanced through the
fourth incision I4. Alternatively, wire 400 may be cut or severed by a tool
such that a portion of wire 400 remains in the body.” (Id.)
Thus, Bergeron’s system relies on moving a connecting rod along a
wire in order to position it between two bone fastener assemblies, where it
can be secured to form the desired spine stabilization system. Making the
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Appeal 2016-003976
Application 13/675,100
rod and wire monolithically—as a single piece—in a way that would meet
the limitations of claim 1 on appeal would make them unsuitable for
Bergeron’s intended purpose, because the rod could not be moved along the
wire to permit the desired minimally invasive surgery. (See id. 12.)
In response to Appellant’s argument on this point, the Examiner
reasoned that “the wire portion is taught to be able to be fixed together with
the rod portion and its ends cut in paragraph 144.” (Ans. 5.)
This reasoning does not persuade us that the rejection is adequately
supported by the references. Bergeron states that, after the rod is advanced
to the bone fastener assemblies and secured there, “wire 400 may be cut or
severed by a tool such that a portion of wire 400 remains in the body.”
(Bergeron 1144.) Bergeron does not describe fixing the wire to the rod,
and, even if it did, they would still be two separate pieces that were later
attached, and therefore not monolithically formed, as required by claim 1.
The Examiner also reasoned that “[i]n paragraph 143, Bergeron
discloses that the rod can be pulled via the wire instead of being advanced
along the wire. This leads to the wire still being able to guide the rod to the
screws while being monolithic to the rod portion.” (Ans. 5.)
This reasoning also does not persuade us that Bergeron would have
made obvious a monolithic rod/wire assembly. Bergeron states that its rod
can “ha[ve] a feature such as hole 407, groove 408, or notch 409 for
attachment to wire 400 such that rod 104 can be pulled via wire 400.”
(Bergeron 1143, emphasis added.) Again, however, this description is one
of attaching a wire and a rod—two separate components—rather than
forming them as a single monolithic unit, as required by claim 1.
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Application 13/675,100
In summary, the Examiner has not persuasively shown that it would
have been obvious, based on the cited references, to form Bergeron’s rod-
and-wire assembly as a single monolithic unit, and therefore has not shown
that the system defined by claim 1 on appeal would have been obvious based
on Bergeron and Lake.
SUMMARY
We reverse the rejection of claims 1—10 under 35 U.S.C. § 103(a)
based on Bergeron and Lake.
REVERSED
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