Ex Parte Kim et al

Patent Trial and Appeal Board

May 3, 2016

11968186 (P.T.A.B. May. 3, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111968,186 0110112008
109587 7590
SPINAL KINETICS, Inc.
501 Mercury Drive
Sunnyvale, CA 94085
05/04/2016
FIRST NAMED INVENTOR
Daniel H. Kim
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
S0134.0014 8480
EXAMINER
MERENE, JAN CHRISTOP L
ART UNIT PAPER NUMBER
3733
MAILDATE DELIVERY MODE
05/04/2016 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 DANIEL H. KIM, THOMAS A. AFZAL, MICHAEL L. REO,
URIEL HIRAM CHEE, IN HAENG CHO, KUNWOO LEE,
CURTIS W. FRANK, and SUNG KYU HA
Appeal 2014-003678
Application 11/968, 186
Technology Center 3700
Before EDWARD A. BROWN, JAMES P. CALVE, and
LEE L. STEPINA, Administrative Patent Judges.
BROWN, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Daniel H. Kim et al. (Appellants) 1 appeal under 35 U.S.C. § 134(a)
from the Examiner's decision rejecting claims 1 and 3---6. Br. 3. We have
jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
CLAIMED SUBJECT MATTER
Representative independent claim 1 recites:
1. A method for implanting a prosthetic intervertebral
disc between adjacent first and second vertebral bodies,
whereby the adjacent first and second vertebral bodies are
1 Spinal Kinetics Inc. is identified as the real party in interest. Br. 3.
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Application 11/968, 186
movable with respect to each other after implantation of the
prosthetic vertebral disc, the method comprising the steps of:
a.) forming one or more indentations on an internal
surface of the first vertebral body and on an internal surface of
the second vertebral body,
b.) implanting a first endplate member of said prosthetic
intervertebral disc onto the second vertebral body, and
c.) implanting a core assembly comprising a second
endplate and a polymeric core member, the polymeric core
member separating the first endplate member from the second
endplate onto the first vertebral body such that a portion of said
core assembly engages at least one of said one or more
indentations, and such that said core assembly is connected to
said first endplate member.
Br. 14, Claims App.
REJECTION
Claims 1 and 3---6 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over William (US 2004/0010316 Al, pub. Jan. 15, 2004),
Eisermann (US 2003/0208273 Al, pub. Nov. 6, 2003), and Trieu (US
2005/0165485 Al, pub. July 28, 2005).
ANALYSIS
The Examiner found William discloses implanting an intervertebral
disc comprising first endplate member 12, and core assembly 14 including
second endplate 20 and core member 22, between first and second vertebral
bodies. Final Act. 2-3 (citing William, paras. 85, 87; Fig. 35). The
Examiner found William does not disclose: "the core member is a
compressible polymeric core member"; step "a"; and the core assembly
engages at least one indentation as in step "c". Id. at 4.
The Examiner also found Eisermann discloses implanting an
intervertebral disc comprising a first endplate member and a second endplate
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having respective anchoring fins 80, 120, and indentations 300 (grooves)
formed on first and second vertebral bodies. Final Act. 5 (citing Eisermann,
paras. 58, 60; Figs. 1, 18). The Examiner concluded it would have been
obvious in view of Eisermann to modify the first endplate member and
second endplate of William to include anchoring fins, and to form
corresponding indentations on the first and second vertebral bodies. Id. at
5-6. The Examiner reasoned that the anchoring fins would anchor the
intervertebral disc, and the indentations/grooves would accommodate the
fins and also help avoid over-insertion and under-insertion of the
intervertebral disc. Id. at 6.
The Examiner found Trieu discloses implanting intervertebral disc
300 comprising, inter alia, a core assembly including compressible
polymeric core member 320. Final Act. 5 (citing Trieu, paras. 35, 75; see
also Fig. 28). The Examiner concluded that it would have been obvious in
view of Trieu to modify William I Eisermann to have a compressible
polymeric core member. Id. at 6. The Examiner reasoned that this
modification would allow the intervertebral disc to elastically deform under
compressive loads and provide other noted effects. Id.
Appellants contend that William's device is designed to be placed in
an intervertebral space that includes "the 'cartilaginous end plate of a
vertebra"' (Br. 8 (citing William, paras. 2, 10, 11, 58, 59; claims 34, 35)),
whereas Eisermann's device is designed to be inserted into an opening
between the vertebrae in which "the cartilaginous end plates have been
removed and the thus-exposed vertebral bone surfaces formed into flat
regions to receive the similarly flat 'bearing surfaces ( 54)' found on the
'articular components (32, 34)"' (id. (citing Eisermann, Figs. 18, 20;
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emphasis added)). According to Appellants, placing indentations or grooves
into the intervertebral faces of the vertebra, "particularly when removing the
'cartilaginous end plate of a vertebra ... ' as apparently is required by the
Eisermann procedure," would be counter to the principle of operation of
William because Eisermann's procedure limits or eliminates splintering of
the vertebra during implantation, and "William has no such splintering
problem since William does not face vertebral bone when implanting the
William device." Id. at 9.
These contentions are not persuasive. Although William describes
implanting the intervertebral disc prosthesis in a cartilaginous end plate of a
vertebra, Appellants have not shown that William's method is limited to
only such implantation. In this regard, the Examiner finds William discloses
that engaging cartilaginous end plates via anchoring elements 24 is an
example of a mounting surface that anchoring elements 24 may engage.
Ans. 6 (citing William, para. 59). William states, "lj] or example, the
anchoring elements 24 may penetrate and be retained within the
cartilaginous end plates of a vertebrae of a patient." William, para. 59; Figs.
1, 2 (emphasis added). The Examiner also finds William discloses that
anchoring elements 24 may be constructed with other configurations without
pointed or sharpened tips. Ans. 6-7 (citing William, para. 60).
Further, accepting Appellants' contention that Eisermann's procedure
limits or eliminates splintering, then both William and Eisermann disclose
implantation procedures that address this same problem. One skilled in the
art would have recognized that Eisermann provides an alternative
intervertebral disc anchoring structure and procedure than William to
address the problem. Appellants have not provided persuasive argument or
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evidence to show that modifying William's implantation procedure to utilize
Eisermann's fins and grooves instead of William's anchoring elements 24,
as proposed by the Examiner, would have had been beyond the level of
ordinary skill or yielded unpredictable results.
Eisermann discloses that to accommodate insertion of prosthetic joint
30 within intervertebral space, S, upper and lower vertebrae Vu, VL are
prepared by forming openings or slots 300 "along the vertebral endplates of
the upper and lower Vu, VL." See Eisermann, para. 58; Figs. 18, 19.
Eisermann does not appear to describe removing vertebral endplates Vu, VL,
but rather, discloses forming openings or slots in these vertebral endplates.
Also, Eisermann does not describe that removal of the cartilaginous endplate
is required in the implantation procedure.
Appellants also contend that inserting Eisermann's fully assembled
ball-and-socket device into a pre-cut indentation or groove would be counter
to the principle of operation of William, which requires axial motion of the
anchoring components into the cartilaginous end plate of a vertebra. Br. 9.
This contention is not persuasive. The Examiner's rejection does not
combine Eisermann's entire ball-and-socket device with William's device.
Ans. 5--6. Rather, the Examiner relies on Eisermann for teaching the use of
fins and indentations for the implantation. Id. Even if William utilizes axial
motion of anchoring elements 24 to engage a cartilaginous end plate of a
vertebra, Appellants have not shown persuasively that Eisermann's fins I
grooves could not be used in William in place of anchoring elements 24.
The Examiner's modification of William would still allow the modified
device to be implanted in vertebral bodies, as claimed.
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Appellants contend that the Examiner provides no substantive
reasoning for combining Trieu' s single implantation step of implanting a
completely assembled device into a spine with the procedure of William or
Eisermann. Br. 9. Appellants contend that the procedures of William and
Eisermann implant prosthetic intervertebral ball and socket-like devices that
are axially stiff and resist axial compression, whereas Trieu's procedure
introduces a pre-assembled intervertebral implant having a compressible
core into an intervertebral space. Id.
Appellants' contentions are not persuasive. First, we disagree with
Appellants' contention that "implanting a device 'having a compressible
polymeric core member"' is required by claim 1. Br. 8 (emphasis added).
Claim 1 recites a "polymeric core member," not a "compressible polymeric
core member."
Second, the Examiner found William discloses various materials can
be used for the core member, and references "paragraph 65 where flexible
and rigid materials may be used." Final Act. 4. William discloses that first
and second implantable members 12, 14, or any parts thereof, can be made
from many different biologically-compatible materials, including, without
limitation, polymeric materials. See William, para. 65. For example,
"elastomers," a known group of compressible polymeric materials, are
mentioned. Id. Accordingly, Appellants' apparent contention that
William's procedure is limited to implanting devices that resist axial
compression is not persuasive.
Third, in light of William's disclosure in regard to polymeric
materials and "flexible materials," Appellants have not shown persuasively
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that Trieu's teaching of using a compressible polymeric core member in an
intervertebral disc is incompatible with William.
Appellants contend that the Examiner's reasoning does not relate to
the claimed process, but only to components of the devices. Br. 11.
Appellants contend that the rejection discusses structural features of the
Eisermann and Trieu devices without regard to the William procedure. Id. at
12.
Appellants appear to contend that the Examiner's findings in relation
to the structural features of the devices taught by Eisermann and Trieu used
in the rejection do not provide reasons to modify William's implantation
procedure. However, in addition to making these findings, the Examiner
provided reasons with a rational underpinning why the proposed structural
modifications to William's device in view of Eisermann and Trieu would
have been desirable in the method of implanting the modified device. Ans.
8. In response, Appellants have not apprised us of any error in the
Examiner's reasoning.
For the above reasons, we sustain the rejection of claim 1, and claims
3---6, depending from claim 1, as unpatentable over William, Eisermann, and
Trieu.
DECISION
The Examiner's decision to reject claims 1 and 3---6 is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
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