Ex Parte Hulliger et al

Patent Trial and Appeal Board

Jul 3, 2017

13227007 (P.T.A.B. Jul. 3, 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.
13/227,007 09/07/2011 Urs HULLIGER 10139/23302 4675
(SYN1252USNP)
76960 7590
Fay Kaplun & Marcin, LLP
150 Broadway, suite 702
New York, NY 10038
EXAMINER
PLIONIS, NICHOLAS J
ART UNIT PAPER NUMBER
3733
MAIL DATE DELIVERY MODE
07/03/2017 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte URS HULLIGER and ADRIAN BAUMGARTNER1
Appeal 2016-002272
Application 13/227,007
Technology Center 3700
Before ULRIKE W. JENKS, JOHN E. SCHNEIDER, and RYAN H. FLAX,
Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a device for determining a deformation of an
intramedullary rod. Claims 1—12 are on appeal as rejected under 35 U.S.C.
§§ 102(e) and 103(a).2 We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as DePuy Synthes Products,
Inc., a subsidiary of Johnson & Johnson, Inc. App. Br. 2.
2 Appellants indicate claims 13—20 are withdrawn. App. Br. (Claim App’x.
3-5).
Appeal 2016-002272
Application 13/227,007
STATEMENT OF THE CASE
The Specification states:
The use of intramedullary nails or rods is well known and
an established form of treatment of fractures in long bones,
especially, for example, in the femur, tibia or humerus. The
intramedullary rod may be inserted into a medullary cavity of a
bone to treat bone fractures in orthopedic surgery and
intramedullary tumors occurring in some forms of cancer. The
rod includes at least one fixing hole arranged at the distal end
and/or the proximal end thereof to aid in attachment thereof to
the bone. The fixing hole may have an internal thread for mating
with a cross lock or screw inserted in the fixing hole through the
bone. A targeting device including an aiming arm may be used
outside of the bone to determine where a transverse hole should
be drilled to insert the cross lock or screw through the fixing hole.
In some cases, however, the rod may bend during insertion of the
rod into the bone such that the aiming arm must be adjusted to
take the bending of the rod into account.
Spec 13.
Claim 1 is the sole independent claim and is reproduced below:
1. A device for determining a deformation of an intramedullary
rod including a channel extending along a longitudinal axis
thereof, comprising:
a longitudinal probe sized and shaped to be inserted into the
channel of the rod and including a deflection detection element;
a head portion including a lumen extending therethrough and a
coupling element arranged to attach the head portion to a
proximal end of the intramedullary rod, the lumen configured to
slidably receive the probe therein; and
a logging unit configured to detect relative movement between
the probe and the head portion and to determine a current path of
the intramedullary rod based on the determined relative
movement.
App. Br. (Claims App’x 1).
2
Appeal 2016-002272
Application 13/227,007
The following rejections are on appeal:
Claims 1—4, 6, 9, 10, and 12 stand rejected under 35 U.S.C. § 102(e)
as anticipated by Benton.3 Final Action 2—3.
Claims 5,8, and 11 stand rejected under 35 U.S.C. § 103(a) over
Benton and Tuma.4 Id. at 4—6.
Claim 7 stands rejected under 35 U.S.C. § 103(a) over Benton and
Janna.5 Id. at 6-7.
FINDINGS OF FACT
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the claims and prior art, and conclusions set out in the Final
Action and Answer. The following findings are made to highlight certain
evidence.
FF1. Benton discloses “[a] device, method and system adapted
to determine a targeting position on a surgically implantable nail
adapted to be used in internal fixation of a bone.” Benton, Abstract;
see also Final Action 2—8, and Ans. 2—9 (discussing Benton).
FF2. Benton discloses:
The present invention solves the distal targeting needs that
are so prevalent in the market today. Also, the present invention
includes guided proximal targeting mechanisms of relatively
simple design that can be used with most contemporary
intramedullary nails (IMN’s). . . .
3 U.S. Patent No. US 7,727,240 B1 (issued June 1, 2010) (“Benton”).
4 U.S. Pat. App. Pub. No. US 2005/0261700 A1 (pub. Nov. 24, 2005)
(“Tuma”).
5 U.S. Pat. App. Pub. No. US 2013/0131679 A1 (pub. May 23, 2013)
(“Janna”).
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Application 13/227,007
Another aspect of the present invention is to provide a
system and method that compensates for nail deflection and the
errors caused by micro-movement inherent in this manually
driven procedure.
Benton 2:28—39; see also Final Action 2—8, and Ans. 2—9 (discussing
Benton).
FF3. Further to the preceding findings of fact, Benton
illustrates such a device and system at Figures 1,5, 14a, and 15a,
reproduced (annotated) below:
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Application 13/227,007
Benton’s Figure 1 (above, right) “shows [the] major portion of a
modular assembly for an intramedullary nail (IMN) securing system,”
including an intramedullary nail (10) coupled to a targeting arm (500)
via a nail adapter (100) (see red bracketing); “[i]n this assembled
state, a targeting probe can be inserted through the nail adapter 100
and coupler rod 200 and into the cannular portion of the distal end of
the IMN 10.” Benton 5:41—67; see also Final Action 2—8, and Ans.
2—9 (discussing Benton). Benton’s Figure 5 (above center) illustrates
the configuration of the nail adapter (100) and coupler rod (200),
shown as secured to the proximal end of the intramedullary nail in
Figure 1 (see relevant portion highlighted by red bracketing and
arrow). Benton’s figures,
show[] the coupler rod 200 inserted into and fully seated
in a nail adapter 100. The penetration of the coupler rod 200
through nail adapter 100 is limited by the engagement of the
flange 210 and the joint rod seat 110. In the fully seated position
shown in FIG. 5, the male threading 230 of the coupler rod 200
should preferably protrude beyond the second end of the nail
adapter 100 for coupling with an IMN 10.
Benton 9:21—27; see also Final Action 2—8, and Ans. 2—9 (discussing
Benton). Benton’s Figures 14a and 15a (above left) show a target
sensor probe assembly (900) configured with the adapter and coupler
rod shown in Figure 5 (see relevant portion highlighted by red
bracketing and arrow) and
Once the assembly shown in FIG. 1 is completed, the
target sensor probe assembly 900, shown in FIGS. 15a-c, can
preferably be mounted on the end of both the nail adaptor 100
and the coupler rod 200. The target sensor probe assembly 900
is preferably used to insert the target sensor 905 into the IMN 10.
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Appeal 2016-002272
Application 13/227,007
Benton 15:58—63, 17:39-18:51; see also Final Action 2—8, and Ans.
2—9 (discussing Benton). “Any deviation to original distance or
rotation that is translated to a calibration probe may be adapted to the
sensor delivery probe.” Benton 17:31—33; see also Final Action 2—8,
and Ans. 2—9 (discussing Benton).
FF4. Benton discloses
[a]s it is understood that the IMN 10 often deforms during
implantation, the distal target securing holes and/or slots in the
IMN 10 can be calibrated, using the sensor calibration probe 990
(see FIGS. 20 and 21). In this way, the amount of deflection of
the implanted nail can be ascertained via the sensor calibration
probe 990.
Benton 6:53—58; see also Final Action 2—8, and Ans. 2—9 (discussing
Benton).
FF5. Further to the preceding findings of fact, Benton
discloses “the target sensor probe assembly 900 (see FIGS. 13-15) is
preferably mounted where the sensor calibration probe 990 was
mounted. Thus, a target sensor can then be inserted into the cannular
portions of the coupler rod 200 and the IMN 10, at least to the desired
distal targeting position.” Benton 7:3—8; see also Final Action 2—8,
and Ans. 2—9 (discussing Benton).
FF6. Benton discloses:
an IMN can deform when implanted into a given patients
intramedullary canal. Therefore, the assembled targeting arm
(whether a distal or proximal arm) is not necessarily parallel to
the implanted IMN to which it is coupled. Rather, the given
targeting arm is generally parallel to the assembled nail adapter
100.
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Application 13/227,007
Benton 11:15—20; see also Final Action 2—8, and Ans. 2—9 (discussing
Benton). Thus, deformation at the distal end of the intramedullary rod
is disclosed to be respective of the stationary nail adapter (100) and
targeting arm (500).
FF7. Benton discloses:
FIGS. 20 and 21 show a sensor calibration probe 990,
which has a similar design to that of the target sensor probe
assembly 900. The primary distinction is that rather than
delivering a target sensor 905, the sensor calibration probe 990
measures the surgically implanted position of the target receiving
bores 13, 15. This calibration helps to estimate the degree of
deflection and deformation that has occurred in the IMN 10 as a
result of the implantation in the medullary canal.
Benton 18:64—19:4; see also Final Action 2—8, and Ans. 2—9
(discussing Benton). The intramedullary rod’s deflection,
deformation, and rotational deflection at its distal end is measured in
this way, relative to its proximal end, at which the nail adapter (100),
for attaching the sensor devices, is coupled.
DISCUSSION
Only those arguments made by Appellants in the Briefs have been
considered in this Decision. Arguments not presented in the Briefs are
waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015).
Anticipation
We find the Examiner has established that claim 1 is anticipated by
Benton. The Examiner provides a detailed and well-reasoned explanation as
to how Benton discloses the claimed subject matter. Final Action 2-4; Ans.
2—4, 7—9; see also FF1—FF8 (highlighting certain evidence). Appellants
have not produced evidence showing, or persuasively argued, that the
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Application 13/227,007
Examiner’s determination is incorrect. We address Appellants’ arguments
below.
Appellants’ argument focuses on the claim term “coupling element”
and Appellants contend Benton does not disclose this claimed feature. App.
Br. 4—6. Appellants summarize their argument as follows:
It is respectfully submitted that Benton fails to disclose or
suggest “a head portion including ... a coupling element
arranged to attach the head portion to a proximal end of the
intramedullary rod,” as recited in claim 1. Rather, Benton
discloses a target sensor probe assembly for an intramedullary
nail securing system mounted on a proximal end of a nail adaptor
and a coupler rod. The Examiner contends that the probe
cylinders 960 for receiving the probe 920 in combination with
the nail adaptor 100 meet the recitation of claim 1. However,
Appellents [sic] submit that the coupling element is a component
of the head portion itself. In contrast, the nail adaptor 100 of
Benton is in no way a component of the probe cylinder 920.
App. Br. 4. Appellants argue that the parts of the intramedullary rod implant
system of Benton that are connected between the rod and the sensor probe
cannot be a part of the sensor device/system. Id. Appellants’ argument is
not persuasive.
The Examiner responded to this argument, stating that the
rejection is not based on the probe cylinder 960 being the
only element of the head portion, but instead, the “head portion”
is the combination of the probe cylinder 960, locking collar 980,
and nail adaptor 100. The recitation of a “head portion” in claim
1 is a broad claim feature that, by itself, cannot be construed to
be limited to an integral structure; nor is there explicit language
in claim 1 that limits the “head portion” to an integral structure.
Thus, “head portion” can be construed to read on a combination
of non-integral structures, such as the combination of the probe
cylinder 960, locking collar 980, and nail adaptor 100.
Ans. 8.
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Application 13/227,007
In the Reply Brief, Appellants respond to the Examiner by contending
“the Examiner is arbitrarily combining multiple components of Benton to fit
the elements of the claim.” Reply Br. 3. Appellants argue that, to satisfy the
claim element, Benton’s nail adaptor (100) must be a part of the probe
cylinder (960). Again, Appellants’ argument is not persuasive.
We find the Examiner has the better position. Reviewing Benton, it is
apparent that the nail adapter, locking collar, and probe cylinder, as well as
the coupler rod, are not part of the intramedullary rod. FF3. It is also
apparent in reviewing Benton that these components together form a device
that, when attached to the proximal end of an intramedullary rod, serve to
provide both the lumen and the coupling element of a “head portion,” as
recited by claim 1, so that the probe sensor may be used therewith. FF3—
FF7. There is no limitation in claim 1 requiring the various elements of the
recited head portion to be integral or a single piece of material or not also
used for other, non-sensor-probe attachment-purposes in the intramedullary
rod system.
In their Reply Brief, Appellants also argue (for the first time in
briefing on this appeal) that Benton does not disclose measuring movement
of the intramedullary rod relative to the head portion. Reply Br. 5. This
argument is also not persuasive.
Benton discloses that the intramedullary rod may
move/deflect/deform when implanted and that such movement is relative to
the fixed orientation of the associated assembled targeting arm, and the nail
adapter to which it is coupled during the implantation process. FF5—FF7.
Thus, Benton discloses using the probe sensor assembly and calibration
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Application 13/227,007
probe to ascertain how the distal end of the intramedullary rod has
potentially moved in this way. Id.
For the reasons set forth above, we affirm the anticipation rejection.
Obviousness
For each obviousness rejection Appellants contend only that the
claims are not obvious for the same reasons they argue claim 1 is not
anticipated by Benton. Therefore, we affirm these rejections for the same
reasons we affirm the anticipation rejection.
SUMMARY
The rejection of claims 1—4, 6, 9, 10, and 12 as anticipated by Benton
is affirmed.
The rejection of claims 5, 8, and 11 as obvious over Benton and Tuma
is affirmed.
The rejection of claim 7 as obvious over Benton and Janna is
affirmed.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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