Ex Parte Williams et al

Patent Trial and Appeal Board

Jul 11, 2013

11461509 (P.T.A.B. Jul. 11, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte LYTTON A. WILLIAMS and SUI-KAY WONG
____________________

Appeal 2010-006355
Application 11/461,509
Technology Center 3700
____________________

Before: MICHAEL L. HOELTER, REMY J. VANOPHEM, and JILL D.
HILL, Administrative Patent Judges.

VANOPHEM, Administrative Patent Judge.

DECISION ON APPEAL

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STATEMENT OF CASE

Appellants appeal under 35 U.S.C. § 134 from a rejection of claims 1-
31. App. Br. 5. We have jurisdiction under 35 U.S.C. § 6(b).
The claims are directed to a method of revising an intervertebral
implant on a spine. Claim 1, reproduced below, is illustrative of the claimed
subject matter.

1. A method of revising an intervertebral implant on a spine
comprising
first and second vertebral bodies adjacent to an
intervertebral space, the intervertebral implant comprises
a first anchor plate secured to the first vertebral body,
a second anchor plate secured to the second vertebral
body, and
a first intermediate component positioned at least
partially between the first and second anchor plates,
the first intermediate component comprising
a concave body attached to the first anchor
plate, the concave body having a concave
recess shaped to articulate with a convex
surface to permit relative motion between the
first and second anchor plates,
the method comprising:
detaching the concave body from the first anchor plate
without removing the first anchor plate from the first vertebral
body; and
removing the concave body from the intervertebral space.

REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
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Baumgartner 5,370,697 Dec. 6, 1994
Boyd 5,425,773 Jun. 20, 1995
Williams 6,113,638 Sep. 5, 2000
Erickson 6,368,350 Bl Apr. 9, 2002
Eisermann 2003/0204261 Al Oct. 30, 2003
Coates 6,899,735 B2 May 31, 2005
Aebi 2006/0122703 Al Jun. 8, 2006

REJECTIONS

The following Examiner’s rejections are before us for review:
1. Claims 6-10 and 13-31 stand rejected under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement.
2. Claims 6-10 and 13-31 stand rejected under 35 U.S.C. § 112,
second paragraph, as being indefinite for failing to particularly point out and
distinctly claim the subject matter which applicant regards as the invention.
3 Claims 6-9, 13-18, 20-27 and 29-31 stand rejected under 35 U.S.C.
§ 102(e) as being anticipated by the disclosure of Eisermann or under 103(a)
as being obvious over the teachings of Eisermann.
4. Claims 23 and 29-31 stand rejected under 35 U.S.C. § 102(e) as
being anticipated by the disclosure of Aebi.
5. Claims 10, 19 and 28 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over the teachings of Eisermann in view of the teachings
of Williams.
6. Claims 1-5, 11 and 12 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over the teachings of Boyd in view of the teachings of
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Baumgartner.
7. Claims 1-5, 11 and 12 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over the teachings of Baumgartner in view of the
teachings of Boyd.
8. Claims 1-5, 11 and 12 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over the teachings of Erickson.

ANALYSIS

Rejection of claims 6-10 and 13-31 under 35 U.S.C. § 112, first paragraph
The Examiner’s basis for rejecting claims 6-10 and 13-31 under the
first paragraph of 35 U.S.C. § 112 is that the application as originally filed
did not provide written description support for a limitation in claims 6, 13,
and 23. Ans. 3. The Examiner addresses the spaced first and second bone
engaging surfaces and considers the recited limitation in each claim “the
entire intermediate component is positioned entirely inferior to the superior
of the first and second bone engaging surfaces and entirely superior to the
inferior of the first and second bone engaging surfaces” to be new matter and
according to the Examiner, Appellants do not have support for this limitation
in these claims. Ans. 4. Further, the Examiner finds that claim 23 also
recites, "the entire spacer is positioned inferior to the entirety of the superior
of the first and second bone engaging surfaces; wherein the entire spacer is
positioned superior to the entirety of the inferior of the first and second bone
engaging surfaces". Ans. 4. Both of these limitations are considered new
matter by the Examiner. Id.
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Appellants contend that nowhere do the claims recite or even suggest
that the intermediate component (or articulating interface, or spacer) must be
below both bone-engaging surfaces, or above both bone-engaging surfaces.
App. Br. 16
Appellants further contend that Figure 41 clearly discloses the subject
matter of claim 6; specifically, that the entire articulating interface is
positioned inferior to the entirety of the superior of the first and second bone
engaging surfaces (which are secured to the vertebral bodies L4 and L5), and
that the entire articulating interface is positioned superior to the entirety of
the inferior of the first and second bone engaging surfaces. App. Br. 11-12.
Appellants also point to Figure 41 which clearly discloses a convex
body 18 and a concave body 22 together that constitute a first intermediate
component. App. Br. 13. As recited by claim 13, first or inferior anchor
plate 16 is secured to vertebral body L5, second or superior anchor plate 20
is secured to vertebral body L4, and the intermediate component (18, 22) is
positioned between the anchor plates. Clms. App’x, App, Br. 32. As is clear
from the figures, according to the Appellants, the entire intermediate
component is positioned inferior to the entirety of the superior of the first
and second bone engaging surfaces (the bone engaging surface on anchor
plate 20, secured to vertebral body L4), and superior to the entirety of the
inferior of the first and second bone engaging surfaces (the bone engaging
surface of anchor plate 16, secured to vertebral body L5). Figures 1-14
provide additional support for the claim 13 embodiment.
With reference to claim 23, Appellants point out that a spacer is
recited instead of an intermediate component. App. Br. 8. Examples from the
disclosure of a spacer, as recited by claim 23, include the first intermediate
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component 18, 22 and fusion device 260, described in paragraph [0094] and
seen in Figure 43. Fusion device 260 attaches to the anchor plates 16, 20 in
the same manner as the concave and convex bodies (18, 22), as described in
paragraph [0094] and illustrated in Figures 42-43. The entire spacer is
positioned between the bone engaging surface of the anchor plates. Nowhere
does any portion of the spacer extend inferior to the inferior of the first and
second bone engaging surfaces (the bone engaging surface on anchor plate
16) or superior to the superior of the first and second bone engaging surfaces
(the bone engaging surface on anchor plate 20).
For the reasons stated above, Appellants assert that the subject matter
of claim 6-10 and 13-31 is not new matter and satisfies the written
description requirement.
In this case we agree with the Appellants that Figs. 1-14 and Figs. 41-
43 illustrate that the entire intermediate component, whether a convex and
concave body or a spacer, is positioned entirely inferior to the superior of the
first and second bone engaging surfaces and entirely superior to the inferior
of the first and second bone engaging surfaces as recited in the independent
claims. It is therefore our view that the specification and drawings convey
with reasonable clarity to those skilled in the art, as of the filing date, that
Appellants constructively possessed the invention as now claimed. This
being the case, we do not sustain the rejection of claims 6-10 and 13-31
under 35 U.S.C. § 112, first paragraph.

Rejection of claims 6-10 and 13-31 under 35 U.S.C. § 112, second
paragraph

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The Examiner’s position for rejecting claims 6-10 and 13-31 under the
second paragraph of 35 U.S.C. § 112 is that the claims are indefinite for
failing to particularly point out and distinctly claim the subject matter which
Appellants regards as the invention. The legal standard for definiteness
under 35 U.S.C. § 112, second paragraph, is whether “those skilled in the art
would understand what is claimed when the claim is read in light of the
specification.” Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d
1565-1576 (Fed. Cir. 1986).
The Examiner finds that claims 6-10 and 13-31 are unclear as
it is impossible for the intermediate component to be positioned inferior
(below) to the superior (upper) of both the first and second bone engaging
surface. The intermediate component cannot be in both positions at the same
time. Ans. 4-5
Appellants contend that nowhere do the claims recite or even suggest
that the intermediate component (or articulating interface, or spacer) must be
below both bone-engaging surfaces, or above both bone-engaging surfaces.
App.Br. 16. Instead, as the claims recite in plain language, the entire
intermediate component (entire articulating interface, entire spacer) is
positioned inferior to the superior of the first and second bone engaging
surfaces, and superior to the inferior of the first and second bone engaging
surfaces. Reply Br. 5.
The Appellants contend and we agree, that the claims as written are
definite and do indeed point out and distinctly claim the subject matter
which Appellants regard as their invention. Therefore we do not sustain the
rejection of claims 6-10 and 13-31 under 35 U.S.C. § 112, second paragraph.

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Rejection of claims 6-9, 13-18, 20-27, and 29-31 as anticipated by
Eisermann

Regarding claim 6 and its dependent claims, the Examiner finds that
Eisermann discloses a method wherein convex and concave bodies that
define an articulating interface, wherein the entire articulating interface is
positioned inferior to the entirety of the superior of the first and second bone
engaging surfaces; and superior to the entirety of the inferior of the first and
second bone engaging surfaces. Ans. 5-6.
Appellants contend that Eisermann does not disclose such a system.
App. Br. 18. Appellants point to Figures 16 and 17 of Eisermann where it
can be seen that the articular interface defined by the convex and concave
bodies (circular dotted line, representing the interface between ball 24 and
components 22a and 22b) is not inferior (below) to the entirety of the
superior (upper) of the first and second bone engaging surfaces, because
toward the center (for example, at line R) it extends superior to (or above)
the upper bone engaging surface seen at the flanges 54 and 56, or at line P1.
App.Br. 18-19. Further Appellants point to paragraph [0067] of
Eisermann’s disclosure which specifies that “… at least a portion of the
abutting articular surfaces 25, 122 of the ball 24 and the articular insert 28 is
positioned beyond the intervertebral disc space defined between the planes
P1 and P2 extending along the bearing surfaces 70 of the endplate flanges
54, 56.” App. Br. 19. Therefore, Appellants contend, and we agree, that
since the abutting surfaces are positioned beyond the bearing surfaces of the
endplate flanges, the entirety of the abutting surfaces of claim 6, or first
intermediate component of claim 13, as well as the spacer of claim 23, is
clearly not “inferior to the entirety of the superior of the first and second
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bone engaging surfaces” and not “superior to the entirety of the inferior of
the first and second bone engaging surfaces” as required by each one of the
recited claims. App. Br. 20. Further, the Examiner appears to acknowledge
Eisermann’s lack of anticipation of the “entirety” limitation of this
placement location. Ans. 6. Accordingly, we do not sustain the rejection of
claims 6-9, 13-18, 20-27 and 29-31 under 35 U.S.C. § 102(e) as being
anticipated by the disclosure of Eisermann.

Rejection of claims 6-9, 13-18, 20-27, and 29-31 as obvious over Eisermann
The Examiner finds Eisermann teaches that the intermediate
component (concave and convex inserts) may be replaced with other
intermediate components with differently shaped articulating surfaces. Ans.
6 (citing Eisermann, para. [0055]). The Examiner identifies Boyd as
evidence that it is known in the art for the entire articulation surface being
“inferior to the superior bone engaging surface and entirely superior to the
inferior bone engaging surface.” Ans. 7. Therefore the Examiner concludes
that it would have been obvious to one having ordinary skill in the art at the
time the invention was made to use an articulating component with an
articulating interface positioned completely between the bone engaging
surfaces as such would provide different movements and ranges of motion as
Eisermann encompassed. Ans. 6-7.
Appellants contend that the § 103(a) rejection is improper because, as
argued above, the Eisermann reference does not “include all limitations of
the claims, as argued above in the discussion of the 102(e) rejection” and
Eisermann also teaches away from the claimed invention. App. Br. 20.
Appellants reference paragraph [0067] of Eisermann which sets forth an
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embodiment using a large articular ball having a diameter greater than the
height of the natural intervertebral disc, and as a result “at least a portion of
the abutting articular surfaces 25, 122 of the ball 24 and the articular insert
28 is positioned beyond the intervertebral disc space defined between the
planes P1 and P2 extending along bearing surfaces 70 of the endplate
flanges 54, 56.” App. Br. 19, see also 20. This teaching of the articular
surfaces extending past at least a portion of the bone engaging surface of one
or both of the endplates, is contra to Appellants teaching. App.Br. 20.
We note that the Examiner referenced Eisermann’s paragraph [0055]
(Ans. 6) which discloses that the originally implanted device “can be
removed from the endplates 26 and replaced with different
types/configurations of articular inserts 28 and/or a different articular ball 24
designed to provide the disc prosthesis 20 with modified articulating
characteristics and movements.” Appellants do not address this general
teaching of being able to replace the implanted device with another having a
different configuration, a different ball, or both. App. Br. 18-22. Instead,
Appellants address Eisermann’s paragraph [0067] which is directed to the
unique geometry of a particular embodiment of the Eisermann. App. Br. 19,
20. Appellants do not show how the Examiner’s reliance on Eisermann’s
paragraph [0055] is in error nor do Appellants show where Eisermann
critizes, discredits or otherwise discourages the claimed limitations.
Accordingly, Appellants’ contentions are not persuasive.
However, we also note that the Examiner, in making the rejection that
these claims are obvious under § 103(a) in view of Eisermann, also relies on
the teachings of Boyd but Boyd is not formally cited by the Examiner as a
basis for the rejection of these claims. Ans. 5. We have been instructed by
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our reviewing court that “[w]here a reference is relied on to support a
rejection, whether or not in a ‘minor capacity,’ there would appear to be no
excuse for not positively including the reference in the statement of the
rejection.” See In re Hoch, 428 F.2d 1341, 1342, n3 (CCPA 1970). We
have also been instructed that “[i]t is well-established that the Board is free
to affirm an examiner’s rejection so long as appellants have had a fair
opportunity to react to the thrust of the rejection.” In re Jung, 637 F.3d
1356, 1365 (Fed. Cir. 2011). In view of these instructions, we reverse the
rejection of claims 6-9, 13-18, 20-27 and 29-31 as being obvious over
Eisermann but we enter a new ground of rejection over the combination of
Eisermann and Boyd to afford a fair opportunity for Appellants to react to
the thrust of the Examiner’s rejection of these claims.

Rejection of claims 23, and 29-31 as anticipated by Aebi
The Examiner finds that Aebi discloses
a method of revising an intervertebral implant comprising
exposing the spine which includes a first and second anchor
plate (10,20), the anchor plates each having central portions
(each plate may be divided into three "portions", a medial
portion, central portion, and lateral portion) displaced from an
anterior edge (anterior edge considered 13,23; see attachment
1), and attaching a spacer (41) to the plates between the central
portions (see fig.2, 4) to prevent movement of the vertebrae
(P0020, P0038). Aebi discloses further a coupling member
(screw 44) that secures the spacer to the anchor plate (see fig.2).
Aebi discloses the anchor plates to be attached to the vertebral
bodies without threaded attachments, see figures 1, 2.
Ans. 7.
Appellants contend Aebi does not disclose an intervertebral implant
with anchor plates, each anchor plate comprising a central portion displaced
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from an anterior edge of the anchor plate, and inserting a spacer between the
central portions as is set forth in claim 23. App. Br. 22. Appellants further
contend that the implant disclosed by Aebi, has a ventral side area 11, a
dorsal side area 12, a top surface 15 and a bottom surface 16. App. Br. 22.
In anatomic terminology, ventral refers to “being or located near, on, or
toward the front or anterior part of the human body” (www.meriam-
webster.com/medical/ventral, retrieved May 21, 2009). Aebi’s means 40
can only be inserted from the ventral (anterior) side area (paragraph 0039)
because its insertion location is limited by the dovetail guides 42, 43 so that
it remains at the anterior edge of the upper and lower sections 10, 20
(Figures 1, 2). App. Br. 22, see also Aebi para. [0039]. Aebi’s means 40 are
not inserted between the central portions of the upper and lower sections 10,
20 (Figure 2), as is required by the recited insertion step of claim 23.
App.Br. 22-23. We further note that the Examiner’s identified anterior edges
13, 23 (Ans. 7) are inconsistent with Aebi’s described anterior/ventral areas
11, 21 (Aebi para. [0039]).
We have been instructed by our reviewing court that every element
and limitation of the claimed invention must be found in a single prior art
reference, arranged as in the claim. See Karsten Mfg. Corp. v. Cleveland
Golf Co., 242 F.3d 1376, 1383 (Fed. Cir. 2001). Here, the Examiner has not
established by a preponderance of the evidence that Aebi anticipates the
claimed invention. Therefore we do not sustain the rejection of claims 23
and 29-31 under 35 U.S.C. § 102(e).

Rejection of claims 10, 19 and 28 as obvious over Eisermann and Williams
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The Examiner rejected dependent claims 10, 19 and 28 under 35
U.S.C. § 103(a) as unpatentable over the teachings of Eisermann and further
in view of the teachings of Williams. Ans. 7. For each claim, Appellants do
not dispute the additional teachings of Williams but instead assert that each
claim is distinguishable “over Eisermann for the reasons set forth above in
the discussion” of their respective parent claim 6, 13 and 23. App. Br. 23-
24. In essence, Eisermann “teaches away from the use of an articulating
interface that does not extend inferior or superior to at least some portion of
one of the corresponding bone engaging surfaces.” App. Br. 23-24. While
the Examiner’s rejection of these parent claims was not sustained supra, a
new ground of rejection was entered based on the additional teachings of
Boyd. Here, in view of Appellants’ arguments, we likewise do not sustain
the Examiner’s rejection of claims 10, 19 and 28 as being obvious over
Eisermann and Williams but we enter a new ground of rejection of these
claims in view of the additional reference to Boyd as above.

Rejection of claims 1-5, 11 and 12 as being obvious over Boyd and
Baumgartner

The Examiner finds that Boyd teaches an implant having first and
second anchor plates and an intermediate component (24) to be attached to
the anchor plates by various means. Ans. 8 (citing Boyd, col. 5, lines 1-3;
col. 8, lines 54-66). However, the Examiner finds that Boyd does not
specifically disclose the means to be detachable. Ans. 8, see also 13.. The
Examiner further finds that Baumgartner discloses an intervertebral implant
that teaches a method of connecting the anchor plates (2, 3) to an
intermediate component (4) in a detachable manner (snap fit or screw; 28),
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such that at a later date it is possible to remove and replace the intermediate
component easily without removing the plates Id. (citing Baumgartner, col.
2, lines 25-31; col. 3, lines 14-18, 59-65). Therefore the Examiner concludes
it would have been obvious to one having ordinary skill in the art at the time
the invention was made to use Boyd’s vertebral device (having a concave
body intermediate component) with Baumgartner’s teaching method of a
detachable connection such that a revision is possible at a later date on the
intermediate component of Boyd’s device (having a concave body). Ans. 8-
9.
Appellants contend that independent claim 1 recites “detaching the concave
body from the first anchor plate without removing the first anchor plate from
the first vertebral body.” App. Br. 24-25. We find Appellants argument to be
persuasive because we do not feel that a person ordinarily skilled in the art
of intervertebral insert devices would gain any teachings from either Boyd or
Baumgartner as to how a concave body (emphasis added) associated with an
intervertebral device is detachable from its anchor plate without removing
the anchor plate from its respective vertebral body. The Examiner has also
failed to provide fact based articulated reasoning how the removal of a
concave body from an end plate could be accomplished from the teachings
of the combined references. Therefore the Examiner has failed to set forth a
prime facie case of obviousness because neither reference discloses the step
of detaching a concave body from the first anchor plate without removing
the first anchor plate from the first vertebral body. Accordingly, we do not
sustain the rejection of claims 1-5, 11 and 12 under 35 U.S.C. § 103(a).

Rejection of claims 1-5, 11 and 12 as being obvious over Erickson
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The Examiner finds that Erickson discloses a method of placing an
intervertebral implant having two anchor plates (20, 21), a concave
intermediate component (22), and anchoring elements (29) into an
intervertebral space. Ans. 10. The Examiner further finds that Erickson
discloses a kit having multiple interchangeable components for the plates
and intermediate components Ans. 10 (citing Erickson, col. 9, lines 36-44).
The Examiner also finds that Erickson does not specifically recite removal
of an intermediate component. Ans. 10. The Examiner further finds that it is
common for surgeons to try several sizes before choosing one of the proper
fit (this is the purpose of providing a kit, to provide the surgeon with options
and the kit itself implies the interchangeability of components, thus making
it common sense to remove one to replace with another). Ans. 10. Therefore
the Examiner concludes it would have been obvious to remove one
intermediate component, in order to try a different sized intermediate
component with the anchor plates for a better fit. Ans 10.
The Appellants contend that in the final office action the Examiner
stated that “This rejection is being made under KSR.” App. Br. 28.
Appellants point out that KSR does not alter the requirement that all
limitations of the rejected claim be found in the prior art. App. Br. 28. In this
instance, Appellants contend, that the criteria that the prior art reference
must teach or suggest all the claim limitations has not been met because the
limitation “detaching the concave body from the first anchor plate without
removing the first anchor plate from the vertebral body and removing the
concave body from the intervertebral space” has not been disclosed and the
Examiner finds that Erickson does not specifically recite removal of an
intermediate component. Ans. 10; App. Br. 28.
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The Examiner’s findings in Erickson are not supported by the
Specification of Erickson. In the first place, Erickson does not disclose a
“kit”. Nowhere in the complete specification is the term” Kit” used by
Erickson. So there cannot be any implication by Erickson of “ …the kit
itself implies interchangeability of components”. Further, the findings made
by the Examiner “…that it is common for surgeons to try several sizes
before choosing one of the proper fit” is at best speculative and unsupported
by evidence or the record of Erickson.
We find Appellants’ argument persuasive and because the Examiner
has failed to provide articulated reasoning with rational underpinnings in
support of this rejection, we do not sustain the Examiner’s rejection of
claims 1-5, 11 and 12 under 35 U.S.C. § 103(a).

DECISION
For the above reasons, all of the Examiner’s rejections of claims 1-31
under either 35 U.S.C. § 112, first paragraph, 35 U.S.C. § 112, second
paragraph 35 U.S.C. § 102(e) or 35 U.S.C. § 103(a) are reversed. However,
we enter a new ground of rejection with respect to these claims based on a
new combination of references that now formally includes the reference to
Boyd which was relied on by the Examiner as a basis for their rejection. As
the new combination of references differs from that previously stated by the
Examiner, and pursuant to our authority under 37 C.F.R. § 41.50(b), we
designate our rejection as a new ground of rejection in order to afford
Appellants a fair opportunity to respond to the thrust of the Examiner’s
rejection.
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37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant
to this paragraph shall not be considered final for judicial review.” 37 C.F.R.
§ 41.50(b) also provides that Appellants, WITHIN TWO MONTHS FROM
THE DATE OF THE DECISION, must exercise one of the following two
options with respect to the new grounds of rejection to avoid termination of
the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of the
claims so rejected or new evidence relating to the claims so rejected, or both,
and have the matter reconsidered by the examiner, in which event the
proceeding will be remanded to the examiner. . .
(2) Request rehearing. Request that the proceeding be reheard under §
41.52 by the Board upon the same record . . .
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

REVERSED

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