MUSC Foundation for Research Development

Patent Trials and Appeals Board

Mar 12, 2020

13957190 - (D) (P.T.A.B. Mar. 12, 2020)

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.
13/957,190 08/01/2013 Bruce M. FRANKEL 206085-0026-00US 2185
10872 7590 03/12/2020
Riverside Law LLP
Glenhardie Corporate Center, Glenhardie Two
1285 Drummers Lane, Suite 202
Wayne, PA 19087
EXAMINER
JOHANAS, JACQUELINE T
ART UNIT PAPER NUMBER
3773
NOTIFICATION DATE DELIVERY MODE
03/12/2020 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):
dcoccia@riversidelaw.com
dockets@riversidelaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte BRUCE M. FRANKEL and MARK EVALD SEMLER
____________

Appeal 2019-004638
Application 13/957,190
Technology Center 3700
____________

Before MICHAEL J. FITZPATRICK, LISA M. GUIJT, and
LEE L. STEPINA, Administrative Patent Judges.

GUIJT, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant1 seeks our review under 35 U.S.C. § 134(a) of the rejection
of claims 1–12, 23, and 33–37. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM IN PART.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies MUSC Foundation for Research
Development as the real party in interest. Appeal Br. 3.
Appeal 2019-004638
Application 13/957,190
2
THE INVENTION
Appellant’s invention relates to “A Skeletal Bone Fixation
Mechanism.” Spec., Title. Claims 1 and 37 are the independent claims on
appeal. Claim 1 is reproduced below as illustrative of the subject matter of
the present invention, with paragraph indentations added for clarity and
disputed limitations italicized for emphasis.
1. A skeletal fixation apparatus, comprising:
two or more fixation rod receiving “U” shaped bodies that
are attached to two or more screws that are adapted to be inserted
into vertebral bodies associated with a patient, each screw having
a screw axis;
two or more cylindrical tower members that are attached
to the two or more bodies to control the movement or alignment
of the two or more bodies when the skeleton fixation apparatus
is being installed in the patient, each tower member having a
tower axis; and
a fixation rod
manufactured with a plurality of curvatures
extending along a length of the fixation rod,
said fixation rod of sufficient strength or rigidity to
stabilize the patient’s spine extending between adjacent
screws of the two or more screws,
said fixation rod being manufactured having a first
bend radius or arc corresponding to a predetermined
medical curvature extending along the length of the
fixation rod and two or more second bend radii or arcs,
each second bend radius or arc defining a local curvature,
each local curvature having an attachment
segment with a generally straight portion having a
local axis that is parallel to each other local axis
and approximately perpendicular with each
respective screw axis,
the first bend radius or arc being different
than the two or more second bend radii or arcs,
the fixation rod with the predetermined medical
curvature being selected based on a medical diagnosis
Appeal 2019-004638
Application 13/957,190
3
associated with stabilizing the two or more vertebral
bodies,
the local curvatures being at two or more locations
on the fixation rod while preserving the medical curvature
in relation to the two or more cylindrical tower members,
the local curvature overlaying the medical
curvature, and the local curvature configured to
immovably fasten the two or more bodies to the fixation
rod and configured to preclude the two or more cylindrical
tower members from contacting each other when the
skeletal fixation apparatus is installed in the patient, and
wherein when the body is immovably attached to the
fixation rod, the screw axis associated with the body aligns with
the tower axis associated with the tower to which the body is
attached, such that the approximate alignment of each local axis
causes the two or more cylindrical tower members to be
approximately parallel.

THE REJECTIONS
The Examiner relies upon the following as evidence in support of the
rejections:
NAME REFERENCE DATE
Prevost US 2011/0106179 A1 May 5, 2011
Peukert US 2011/0196426 A1 Aug. 11, 2011
The following rejections are before us for review:
I. Claims 33, 35, and 36 stand rejected under 35 U.S.C.
§ 112(d) for being in an improper dependent form.
II. Claims 1–12, 23, 33, 34, and 37 stand rejected under
35 U.S.C. § 102(a)(1) as anticipated by Peukert.
III. Claims 35 and 36 stand rejected under 35 U.S.C. § 103 as
unpatentable over Peukert and Prevost.
Appeal 2019-004638
Application 13/957,190
4
OPINION
Rejection I
The Examiner correctly finds that claims 33, 35, and 36 depend from
cancelled claim 30, and therefore, are in improper dependent form. Final
Act. 3. Appellant acknowledges the necessity of amending the claims to
overcome the Examiner’s rejection. Appeal Br. 10. For purposes of
Rejection II, we consider claims 33, 35, and 36 to depend from independent
claim 1.
Accordingly, we sustain the Examiner’s rejection of claims 33, 35,
and 36 under 35 U.S.C. § 112(d).

Rejection II
Independent claim 1 and dependent claims 2–12, 23, 33, and 34
Regarding independent claim 1, the Examiner finds that Peukert
discloses, inter alia, a skeletal fixation apparatus comprising fixation rod
receiving “U” shaped bodies (i.e., rod receivers 420), each attached to a
screw (i.e., polyaxial bone screws 410), and also cylindrical tower members
(i.e., extension tubes 210) attached to the bodies. Final Act. 4 (citing, e.g.,
Peukert ¶¶ 51, 52, Figs. 2, 4, 14). The Examiner also finds that Peukert
discloses a fixation rod 600 made with a plurality of curvatures along its
length, including: (i) a first bend radius corresponding to a predetermined
medical curvature extending along its length (i.e., “dotted line L” as depicted
in Figure 14); and (ii) two or more second bend radii each defining a local
curvature having an attachment segment with a generally straight portion
and a local axis parallel to each other local axis and approximately
perpendicular with each respective screw axis (i.e., Figure 14 “shows three
Appeal 2019-004638
Application 13/957,190
5
channel markers rendering three local curvatures in the rod”), as claimed.
Id. at 5 (citing Peukert, e.g., ¶ 67, Fig. 14); see also Ans. 3 (“Fig. 14 of
Peukert coupled with the disclosure of [Peurkert’s paragraph 67] and the
concept that the tube connectors are maintained parallel to one another as
described in [Peurkert’s paragraph 31] reasonably teaches all the limitations
of claim 1 to one of ordinary skill in the art”). The Examiner provides an
annotated Figure 14 of Peukert, reproduced below. Final Act. 8.

The Examiner’s annotated Figure 14 of Peukert is “a perspective view of a
series of pedicle screws with extension tubes and other components . . . , the
pedicle screws shown with a contoured guide member,” wherein the
Examiner has identified local axis as being parallel to each other and
approximately perpendicular to screw axes. Peukert ¶ 21; Final Act. 8.
Appellant argues, inter alia, that “[r]egardless of what shape the
hypothetical path “L” has, persons having skill in the art would understand
that a curved rod following a path can take on any number of different
shapes,” and that “[t]he guide member 700 of Peukert merely has to pass
Appeal 2019-004638
Application 13/957,190
6
through each of the channel markers of the pedical screw assembles 400.”
Appeal Br. 13. Appellant submits that “Peukert merely states that a ‘fixation
rod may be bent and shaped to follow a curved path defined by channel
markers,’ however, “[n]owhere does Peukert provide a guide member 700
that has the exact curvature of path ‘L,’ or a guide member 700 [having a
general curvature with discrete attachment segments that have a longitudinal
axis that does not align with the general curvature,]” as claimed. Id.
Appellant submits, therefore, that Peukert fails to disclose a fixation rod with
local curvatures having an attachment segment with a generally straight
portion, as claimed, let alone straight portions with local axes parallel to one
another. Id.; see also Reply Br. 2 (“dashed line ‘L’ does not possess any
straight segments, and the actual depiction of the guide member 700 only
has a single global curvature while the dashed line ‘L’ has at least three
roughly defined undulations.”); id. at 3 (“persons having skill in the art
understand that there are infinite paths between two points”).
To anticipate a claim, a prior art reference must disclose every
limitation of the claimed invention, either expressly or inherently. Blue
Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1341 (Fed. Cir. 2016).
Peukert discloses that “tube connectors . . . secure the extension tubes
in a fixed relationship in which the tubes are maintained parallel to one
another,” such that “the proximal ends of the tubes represent the relative
positions of the corresponding implant because the extension tubes have the
same length,” and wherein “[t]he proximal ends of the parallel tubes can
incorporate templates, which represent the rod receiving channels of each
corresponding implant from which the tube extends,” for example, “the
templates are in the form of U-shaped notches at the proximal ends of the
Appeal 2019-004638
Application 13/957,190
7
extension tubes.” Peukert ¶ 31; see also id. ¶ 51 (“[r]od receiver 420 is
generally cylindrical, but interrupted at two sections, forming diametrically
opposed U-shaped channels 26,” which collectively form a transverse
conduit through rod receiver 420 to receive a section of a spinal fixation
rod”). Peukert also discloses that
[c]hannel markers provide a visual representations of the rod
receiving channels on spinal implants. When channel markers
are used together on a series of extension tubes, the channel
markers provide a visual outline of how the rod needs to be
shaped in order to pass through each implant. In many cases the
spinal implants and their rod receiving components are not
arranged in a straight line, but instead follow a curved path, such
as the curved path shown by the dashed line “L” in FIG. 14.
Because the channel markers indicate the relative positions of the
rod receiving channels on the spinal implants, the channel
markers form a template that can be used to shape a fixation rod
prior to insertion. The fixation rod may be bent and shaped to
follow a curved path defined by channel markers. During the
shaping process, the rod can be set periodically into the channel
markers to monitor the shaping and confirm a proper shaping.
Id. ¶ 67 (emphasis added).
We find that a preponderance of evidence supports the Examiner’s
reliance on Peukert for disclosing a fixation rod with a first bend radius
extending along the length of the fixation rod, because—as discussed
supra—Peukert discloses that rod receiving components may be arranged in
a curved path (i.e., dashed line “L”), and that the fixation rod may be bent to
follow the curved path, for example, fixation rod 600 may be bent to have a
general curvature that mimics the curvature of guide rod 700, as depicted in
Figure 14. Cf. Spec. ¶ 4 (acknowledging that, with reference to Figure 1,
that “[c]onventional fixation rod 120 may include a predetermined bend
Appeal 2019-004638
Application 13/957,190
8
radius or arc (hereinafter, a ‘medical curvature’) based on a medical
diagnosis”).
However, we are persuaded by Appellant’s argument that Peukert’s
Figure 14 fails to disclose a fixation rod with two or more bend radii
defining a local curvature, as compared to the first bend radius. In other
words, we agree with Appellant that Peukert merely discloses a general
curvature with respect to fixation rod 600, as fixation rod 600 is shaped to
conform to the shape of guide member 700 (for example, as guide rod 700 is
depicted with a general curvature in Figure 14), wherein guide member 700
is shaped to be placed within Peukert’s rod receivers. As argued by
Appellant, Peukert teaches that guide member 700 (and therefore, fixation
rod 600) is shaped to pass through the channel markers, or to follow a
curved path such as shown by dashed line L, but does not disclose that guide
member 700 (and therefore, fixation rod 600) is shaped specifically into
dashed line “L” as drawn in Figure 14.
Notably, although Peukert discloses, with respect to conventional rod
insertion systems, that rod receiving channels are known to form “a complex
serpentine or other non-linear path to which the rod must conform,” Peukert
does not disclose how Peukert’s rod insertion system, which relies on
threading a guide rod through consecutive rod receiving channels, may be
executed when rod 600 has a serpentine shape, as opposed to having a
general curvature.2 Peukert ¶ 28. In sum, Peukert’s disclosure of offset U-

2 See Reply Br. 5 (arguing that “a rod with multiple local curvatures would
be physically impossible to navigate in [Peukert’s] minimally invasive
procedure,” wherein “tandem movements of the rod and guide member are
limited to two dimensions making it impossible to thread through multiple
curvatures through multiple parallel points”).
Appeal 2019-004638
Application 13/957,190
9
shaped channels of rod receivers and also of bending a fixation rod to follow
a curved path defined by the rod receivers does not support, by a
preponderance of the evidence, a finding that Peukert’s fixation rod is bent
into a shape having local curvatures as claimed, rather than being bent
merely into a generally curved shape suitable for receipt in a path defined by
rod receiving channels.
Further, although Peukert depicts straight transverse conduits between
each of the U-shaped channels of the rod guidance assemblies 200 of
extensions tubes 210, Peukert does not disclose that fixation rod 600 is
shaped to exhibit straight segments in the portions of fixation rod 600 that
pass through such conduits, as required by claim 1.
Accordingly, we cannot sustain the Examiner’s rejection of
independent claim 1, and claims 2–12, 23, 33, and 34 depending therefrom.
Independent claim 37
Independent claim 37 recites, in relevant part, “a fixation rod having a
length, a general curvature along the entire length, and a plurality of
segments along the length and within the general curvature, wherein the
attachment segments each have a longitudinal axis that does not align with
the general curvature.” Appeal Br. 27 (Claims App.). The Examiner relies
on Peukert for disclosing fixation rod 600, as claimed. Final Act. 15 (citing
Peukert ¶ 77, Fig. 14). The Examiner refers to the annotated Figure 14 of
Peukert, reproduced below. Id. at 16.
Appeal 2019-004638
Application 13/957,190
10

Appellant argues that Peukert “fails to describe, implicitly or
explicitly, that guide member 700 has a length, a general curvature along the
entire length, and a plurality of attachment segments along its length,
wherein the attachment segments each have a longitudinal axis that does not
align with the general curvature.” Appeal Br. 17.
Similar to the rejection of claim 1, we agree with Appellant that a
preponderance of the evidence fails to support the Examiner’s finding that
Peukert’s fixation rod 600 is disclosed to have attachment segments having a
curvature that is different from the general curvature of the rod, as required
by claim 37.
Accordingly, we also do not sustain the Examiner’s rejection of
independent claim 37.

Appeal 2019-004638
Application 13/957,190
11
Rejection III
The Examiner’s reliance on Prevost for disclosing changing the rod’s
cross-section does not cure the deficiencies in the Examiner’s rejection of
independent claims 1 and 37 supra. Final Act. 18.
Accordingly, for the reasons set forth supra, we also do not sustain the
Examiner’s rejection of dependent claims 35 and 36.

CONCLUSION
In summary:
Claims
Rejected
35
U.S.C. §
Reference(s) Affirmed Reversed
33, 35, 36 112(d) 33, 35, 36
1–12, 23,
33, 34, 37
102(a)(1) 1–12, 23,
33, 34,
37
35, 36 103 35, 36
Overall
Outcome
33, 35, 36 1–12, 23,
34, 37
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).
AFFIRMED IN PART