Ex Parte re et al

Patent Trial and Appeal Board

Sep 27, 2013

12426354 (P.T.A.B. Sep. 27, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte PAUL RE, MARK A. JOHANSON, and
PETER F. MARSHALL
__________

Appeal 2012-001429
Application 12/426,354
Technology Center 3700
__________

Before ERIC GRIMES, LORA M. GREEN, and FRANCISCO C. PRATS,
Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal1 under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 22-31, 85-88, 158, and 159. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 The Real Party in Interest is Tyco Healthcare Group LP (Appeal Br. 1).
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STATEMENT OF THE CASE
The Specification discloses a “surgical apparatus and procedures for
reconstructing a ligament” (Spec. 2:4-5).
Claims 22, 28 and 85 are representative and read as follows:
22. A method for securing a graft ligament in a bone tunnel,
comprising the steps of:
(1) looping a graft ligament through a graft hole in a graft ligament
support block,
advancing the graft ligament support block into the bone tunnel,
withdrawing the graft ligament support block from within the bone
tunnel,
re-advancing the graft ligament support block and the graft ligament
into the bone tunnel, and forming a transverse tunnel in the host bone, with a
transverse fixation pin hole in the graft ligament support block being aligned
with the transverse tunnel in the host bone; and
(2) pinning the graft ligament support block within the bone tunnel by
advancing a transverse fixation pin along the transverse tunnel in the host
bone and into the transverse fixation pin hole in the graft ligament support
block.

28. A method for revising a graft ligament in a bone tunnel, said
method comprising the steps of:
unpinning a first graft ligament support block from within a bone
tunnel by withdrawing a transverse fixation pin from a first transverse
fixation pin hole in the first graft ligament support block and from a
transverse tunnel in a host bone;
withdrawing the first graft ligament support block from the bone
tunnel;
advancing a second graft ligament support block into the bone tunnel
so that a second transverse fixation pin hole in the second graft ligament
support block is aligned with the second transverse tunnel; and
pinning the second graft ligament support block within the bone
tunnel by advancing the transverse fixation pin along the transverse tunnel in
the host bone and into the second transverse fixation pin hole in the second
graft ligament support block.

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85. A method for revising a graft ligament in a bone tunnel,
comprising the steps of:
engaging an internal tapped hole in a transverse fixation pin with a
removal tool;
withdrawing the transverse fixation pin from a transverse tunnel with
the removal tool engaged with the internal tapped hole;
withdrawing a graft ligament support block from within the bone
tunnel;
repositioning the graft ligament support block into the bone tunnel;
and
pinning the graft ligament support block within the bone tunnel by
advancing the transverse fixation pin along the transverse tunnel in the host
bone and into the transverse fixation pin hole in the graft ligament support
block.

The claims stand rejected as follows:
• Claims 28-31 under 35 U.S.C. § 112, first paragraph, as failing to
comply with the written description requirement, i.e., for containing new
matter (Ans. 4-5);
• Claims 22-31, 158, and 159 under 35 U.S.C. § 103(a) in view of
Lombardo,2 Whelan3 and Kim4 (Ans. 5-9);
• Claims 85-88 under 35 U.S.C. § 103(a) in view of Lombardo,
Whelan, Kim and Berger5 (Ans. 9-10).
I.
The Examiner has rejected claims 28-31 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement.

2 Lombardo et al., US 2005/0033301 A1, Feb. 10, 2005.
3 Whelan, US 6,132,433, Oct. 17, 2000.
4 Kim, US 6,355,066 B1, Mar. 12, 2002.
5 Berger, US 6,436,100 B1, Aug. 20, 2002.
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The Examiner finds “the specific claimed steps[of claim 28] of using a
second support block are new matter” (Ans. 5). According to the Examiner,
“[w]hile the Specification mentions. . . a second graft ligament support
block,” the disclosure as filed “does not detail the specifics of how the
procedure utilizes a second graft ligament support block” (id.).
Appellants contend that “support for inserting a second support block”
may be found in originally filed claim 28,6 which is directed to a method for
revising a graft ligament in a bone tunnel. (App. Br. 6).7 Appellants argue
that originally filed claim 28 discloses that “a first, previously positioned
graft ligament support block is unpinned and withdrawn from the bone
tunnel and a second graft ligament support block is advanced within the
bone tunnel” (id.).

6 Originally filed claim 28 reads as follows:
28. A method for revising a graft ligament in a bone tunnel, said
method comprising the steps of:
unpinning a graft ligament support block within a bone tunnel by
withdrawing a transverse fixation pin from a transverse fixation pin hole in
the graft ligament support block and from a transverse tunnel a host bone;
withdrawing the graft ligament support block back down the bone
tunnel;
advancing a graft ligament support block into the bone tunnel so that a
transverse fixation pin hole in the support block is aligned with the
transverse tunnel; and
pinning the graft ligament support block within the bone tunnel
by advancing the transverse fixation pin along the transverse tunnel in the
host bone and into the transverse fixation pin hole in the graft ligament
support block.
7 Appellants’ argument refers to both claim 85 and claim 28 (App. Br. 6).
However, the claim quoted in support of the argument is originally filed
claim 28, not originally filed claim 85 (id.). We therefore understand
Appellants’ argument to rely on claim 28.
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The Examiner responds that the recitation in claim 28 of “a graft
ligament support block” in two occurrences “is not sufficient support for a
first and second block” (Ans. 11, emphasis deleted). The Examiner reasons
that “claim 28 provides no order to the steps … [and] the step of ‘advancing
a graft ligament support block into the bone tunnel’ is logically the first step
… [because the] block must be inserted before being unpinned and
withdrawn” (id.). The Examiner reasons further that claim 28 is “describing
a single block … [and the] written description fails to explain the specifics
of how one of ordinary skill … is to use a second graft ligament support
block in the procedure” (id.).
We find that the preponderance of the evidence supports the
Examiner’s position that claim 28 lacks adequate written descriptive support
in the Specification. As stated in TurboCare Div. of Demag Delaval
Turbomachinery Corp. v. General Elec. Co., 264 F.3d 1111, 1118 (Fed. Cir.
2001), “[t]he written description requirement and its corollary, the new
matter prohibition of 35 U.S.C. § 132, both serve to ensure that the patent
applicant was in full possession of the claimed subject matter on the
application filing date.” However, “[i]t is not necessary that the application
describe the claim limitations exactly, but only so clearly that persons of
ordinary skill in the art will recognize from the disclosure that appellants
invented processes including those limitations.” In re Wertheim, 541 F.2d
257, 262 (CCPA 1976) (citation omitted).
Here, Appellants point to originally filed claim 28 as providing
support for the claim limitation of advancing a second support block into the
bone tunnel because originally filed claim 28 recites the steps of both
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“withdrawing the graft ligament support block” and “advancing a graft
ligament support block into the bone tunnel” (Appeal Br. 6, emphasis
deleted). However, method steps are not ordinarily construed to require an
order unless they expressly or implicitly require performance in that order.
Altiris, Inc. v. Symantec Corp., 318 F.3d 1363, 1369 (Fed. Cir. 2003) (citing
Interactive Gift Express, Inc. v. CompuServe Inc., 256 F.3d 1323 (Fed. Cir.
2001)). Thus, the advancing step may refer to placement of the support
block which occurs before the step of withdrawing the support block.
Appellants also argue that “it would be obvious to insert a second
support block into the bone tunnel, e.g., as a replacement to a defective first
support block” (Appeal Br. 6). “Entitlement to a filing date does not extend
to subject matter which is not disclosed, but would be obvious over what is
expressly disclosed.” Lockwood v. American Airlines Inc., 107 F.3d 1565,
1571-72 (Fed. Cir. 1997). Rather, “[o]ne shows that one is ‘in possession’
of the invention by describing the invention, with all its claimed limitations,
not that which makes it obvious.” Id. at 1572.
Since Appellants’ arguments do not persuade us that the Examiner
erred in rejecting of claims 28-31 for lack of written description, we affirm
the rejection.
II.
Issue
The Examiner has rejected claims 22-31, 158, and 159 under 35
U.S.C. § 103(a) as obvious in view of Lombardo, Whelan, and Kim (Ans.
5).
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The Examiner finds that Lombardo discloses “a method for securing a
graft ligament in a bone tunnel using a graft ligament support block 12,
ligament 59, and transverse fixation pin” (id.). The Examiner finds further
that the Lombardo method includes the steps of looping the “graft ligament
through a graft hole in a graft ligament support block … advancing the …
support block into the bone tunnel, [and] forming a transverse tunnel in the
host bone” (id. at 6). The Examiner finds that Lombardo also discloses
“pinning the graft ligament support block within the bone tunnel by
advancing a transverse fixation pin along the transverse tunnel … and into
the transverse fixation pin hole” (id.). The Examiner finds that Lombardo
discloses “checking the alignment of the support block” (id. at 7). The
Examiner finds that Lombardo is unclear regarding the step of “withdrawing
the graft ligament support block from within the bone tunnel, [and] re-
advancing the graft ligament support block … into the bone tunnel,” as
recited in claim 22 (id. at 6).
The Examiner concludes that “if the alignment was checked and
found incorrect, it would have been obvious to adjust the position of support
block” (id. at 7). The Examiner further concludes that “it would have been
obvious to insert the graft ligament and block into the tunnel, withdraw it
(which includes backing it up just a little) and re-advanc[e] said ligament
and block to achieve a desired rotation placement and/or depth placement”
for proper alignment (id. at 7-8). The Examiner reasons that, because the
“tunnel in the femur is very short[,] total [and] full removal from the femoral
tunnel to realign [the support block] would only require a short distance” (id.
at 8).
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The Examiner finds that Whelan discloses “a similar method of
securing a graft ligament in a bone and states [that] revision surgery is
known in the art” (id. at 8). The Examiner concludes that it would have
been obvious for one having ordinary skill in the art to unpin the support
block and “withdraw[ ] the pin and block to correct any imperfections and
replace the block with a second block of a better fit/unbroken/materially a
better match for the patient” (id.). The Examiner relies on Kim to supply
dependent claim limitations.
Appellants contend that Lombardo would not have made obvious the
method of claim 22 with the step of “withdrawing the graft ligament support
block from within the bone tunnel, [and] re-advancing the graft ligament
support block and the graft ligament into the bone tunnel” (App. Br. 7) and
the claim 28 method of “‘withdrawing the first graft ligament support block
from the bone tunnel,’ and ‘advancing a second graft ligament support block
into the bone tunnel’” (id. at 11).
The issues presented are: whether the evidence of record supports the
Examiner’s conclusion that Lombardo would have made obvious the
methods of claims 22 and 28 with the steps of “withdrawing the support
block from within the bone tunnel, [and] re-advancing the … support block
and the graft ligament into the bone tunnel” and “withdrawing the first graft
ligament support block from the bone tunnel; [and] advancing a second graft
ligament support block into the bone tunnel,” respectively.
Findings of Fact
FF1. Lombardo discloses a “graft retaining system for retaining a
graft in a bone tunnel” (Lombardo 2, ¶ 0016).
App
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FF6. Lombardo discloses that the “graft block 12 comprises a body
20” (id. at 6, ¶ 0084).
FF7. Lombardo discloses that loop 16 has “a proximal end 58
extending below the proximal end 24 of the body 20 to receive a graft 59”
(id. at 7, ¶ 0084).
FF8. Lombardo discloses that a “large aperture 40 extends
transversely through the body 20 between faces 28 and 30. A chamfer 41
extends radially outwardly from the large aperture 40 and provides a
tapering transition from the faces 28 and 30 to the large aperture 40” (id. at
7, ¶ 0084).
FF9. Lombardo discloses that the “diameter of the graft block body
20 is preferably slightly less than the diameter of the bone tunnel 60 to
enable the body 20 to rotate about its axis to facilitate engagement with a
cross-pin 14 while maintaining its longitudinal orientation within the tunnel”
(id. at 7, ¶ 0085).
FF10. Lombardo discloses that if “the graft block 20 … aperture axis
[is] partially out of alignment with the [cross-]pin axis, the tapered distal end
106 [of the cross-pin] and the chamfer 41 will engage one another and cause
the graft block 12 to rotate … to align the aperture 40 with the pin 14” (id. at
7, ¶ 0087). “Also optionally, an arthroscope can be directed down the
locator rod 800 cannula 816 to verify the alignment of the graft block 12
relative to the transverse bone hole 64” (id. at ¶ 0109).
FF11. Whelan discloses “a surgical method for loading tendon grafts
into a joint and fixating the grafts using a transverse, intraosseous
implant. . . . The procedure . . . is indicated for revisions that would
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otherwise be jeopardized by secondary femoral tunnel creation” (Whelan,
col. 2, ll. 26-31).
Principles of Law
In determining whether obviousness is established by combining the
teachings of the prior art, “the test is what the combined teachings of the
references would have suggested to those of ordinary skill in the art.” In re
Keller, 642 F.2d 413, 425 (CCPA 1981).
Analysis
Claim 22, which is set forth above, is directed to a method for
securing a graft ligament in a bone tunnel. The method comprises the steps
of, among other steps, looping a graft ligament through a graft hole in a graft
ligament support block, advancing the support block into the bone tunnel,
withdrawing the support block from within the bone tunnel, re-advancing the
support block into the bone tunnel, forming a transverse tunnel in the host
bone, and pinning the support block within the bone tunnel by advancing a
transverse fixation pin along the transverse tunnel.
The Examiner asserts, and Appellants do not dispute, that Lombardo
discloses a method that includes the steps of looping a graft ligament
through a graft hole in a graft ligament support block, and advancing the
graft ligament support block into the bone tunnel. Additionally, the
Examiner asserts, and Appellants do not dispute, that Lombardo discloses
pinning the graft ligament support block within the bone tunnel.
Appellants argue, however, that the cited references would not have
made obvious the steps of “withdrawing the graft ligament support block
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from within the bone tunnel, [and] re-advancing the graft ligament support
block and the graft ligament into the bone tunnel” as recited in claim 22
(App. Br. 7) because “Lombardo fails to disclose a revision procedure
including withdrawing a support block from within the bone tunnel” (id. at
9). Appellants argue that “[b]ecause of the placement of aperture 40
midway along the graft block 12 and the inclusion of chamfer 41, Lombardo
does not disclose … [a reason] to withdraw or ‘fully remove’ the graft block
12 from within the bone tunnel to align aperture 40 with a fixation pin” (id.).
Appellants’ arguments are not persuasive. Although Lombardo does
not expressly disclose withdrawing the support block form the bone tunnel,
we agree with the Examiner that one of skill in the art, in view of the cited
references, would have appreciated that intra-operative revisions would
sometimes be required to achieve adequate placement of the support block
within the bone. Whelan discloses that revisions are known for established
fixated grafts, and Lombardo discloses that the diameter of support block is
less than the diameter of the bone tunnel. Lombardo also discloses optional
features to ensure alignment, and methods of checking the alignment. Thus,
we agree with the Examiner that it would have been obvious to one of skill
in the art that intra-operative revisions could be conducted to correct for a
significant rotational misalignment by withdrawing the support block from
the bone tunnel. The fact that Lombardo discloses a chamfer is not
persuasive because one of skill in the art would have appreciated that the
chamfer would only be useful for correcting for a limited degree of
misalignment.
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Thus, we affirm the rejection of independent claim 22 as being
obvious in view of Lombardo, Whelan and Kim. Dependent claims 23-27,
158 and 159 have not been argued separately, and therefore fall with claim
1. 37 C.F.R. § 41.37(c)(1)(vii).
Appellants also argue the rejection of independent claim 28 (App. Br.
11). Independent claim 28, which is set forth above, is directed to a method
for revising a graft ligament in a bone tunnel. The method comprises the
steps of unpinning a first graft ligament support block from within a bone
tunnel, withdrawing the first graft ligament support block from the bone
tunnel, advancing a second graft ligament support block into the bone
tunnel, and pinning the second graft ligament support block within the bone
tunnel.
Appellants argue that “Lombardo fails to disclose … a revision
procedure … [and] fails to disclose the withdrawal of either a graft ligament
support block from a bone tunnel or the withdrawal of a transverse fixation
pin from a first transverse fixation pin hole as recited in Claim 28” (App. Br.
11-12). Appellants argue that “[s]ince Lombardo fails to disclose the
withdrawal of a graft ligament support block, Lombardo also fails to
disclose advancing a second graft ligament support block into the bone
tunnel” (id.). Appellants argue that Whelan does not cure the deficiencies of
Lombardo because “Whelan does not include the use of [a] graft ligament
support block” and therefore does not disclose withdrawing a graft ligament
support block from within a bone tunnel or advancing a second graft
ligament support block into the bone tunnel (id. at 12).
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These arguments are not persuasive. As discussed above, the
combination of Lombardo and Whelan would have made obvious intra-
operative revisions of Lombardo’s graft ligament installment procedure
using a support block. Further, Whelan discloses the concept of post-
operative revisions of graft ligament constructions. Although Whelan does
not disclose procedures using a support block, it would have been obvious to
one of skill in the art that the general concept of revisions as disclosed by
Whelan could be applied to Lombardo’s graft ligament installment
procedures because one would expect problems to arise in at least a certain
percentage of patients that have undergone graft ligament installment
procedures. Moreover, it would have well within the level of skill of the
ordinary artisan to determine when such revisions are necessary. It would
have been obvious to one of skill in the art to use a second graft ligament
support block in revision procedures where the support block was aging or
defective or where improved support blocks had become available.
Thus, we affirm the rejection of independent claim 28 as being
obvious in view of Lombardo, Whelan and Kim. Dependent claims 29-31
have not been argued separately and therefore fall with claim 1. 37 C.F.R.
§ 41.37(c)(1)(vii).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Lombardo would have made obvious the methods of claims 22 and 28 with
the steps of “withdrawing the support block from within the bone tunnel,
[and] re-advancing the … support block and the graft ligament into the bone
tunnel” and “withdrawing the first graft ligament support block from the
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bone tunnel; [and] advancing a second graft ligament support block into the
bone tunnel,” respectively.
III.
Issue
The Examiner has rejected claims 85-88 under 35 U.S.C. § 103(a) as
obvious in view of Lombardo,Whelan, Kim and Berger (Ans. 9). The
claims have not been argued separately and therefore stand or fall together.
37 C.F.R. § 41.37(c)(1)(vii). We thus, focus our analysis on claim 85, and
claims 86-88 stand or fall with that claim.
The Examiner relies on Lombardo, Whelan, and Kim as discussed
above. The Examiner finds that “revision surgery is known in the art” (Ans.
9). The Examiner concludes that “it would have been obvious … for one
having ordinary skill in the art to have unpinned the support block by
withdrawing the pin and block to correct any imperfections, misalignments
or to replace graft ligament with predictable results” (id. at 9-10). The
Examiner finds that Lombardo “fails to teach an internal tapped hole in …
the transverse fixation pin 102” (id. at 10). The Examiner finds that Berger
discloses “a bone screw which has an internal tapped hole 58 and shaped
drive 38 which attaches to an installation tool” (id.). The Examiner
concludes that it “would have been obvious to one having ordinary skill in
the art to have used the internal tapped hole 58 and shape[d] drive 38
configuration taught by Berger for the hexagonal shaped drive 112 of
Lombardo … to fixedly attach the transverse fixation pin to the insertion
tool for better control by the surgeon” (id.).
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Appellants argue that Berger discloses “a cannulated internally
threaded bone screw 20 and reduction driver device 22 . . . [such that the]
driver device . . . is configured to be locked together with the bone screw to
form a bone reduction and fixation assembly” (App. Br. 13). Appellants
argue that “it would not have been obvious to modify the cross-pin of
Lombardo to include an internal thread . . . because the method of Lombardo
does not require any further manipulation of the assembly once the support
block is pinned in place using the cross-pin” (id. at 14). Appellants also
argue that “Berger does not disclose the use of the internally threaded
portion of the bone screw to facilitate withdrawal of the bone screw from
bone” and thus the cited references do not disclose engaging an internal
tapped hole with a removal tool (id.).
The issue presented is: Does the evidence of record support the
Examiner’s conclusion that it would have been obvious to one of skill in the
art to modify Lombardo’s method to provide an internal tapped hole on the
transverse fixation pin for engagement with a removal tool?
Additional Findings of Fact
FF12. The Specification discloses that a “socket 1620 is formed in
the proximal end of removable transverse fixation pin 1600 . . . . Socket
1620 may be adapted to receive a rotational-type driver (e.g., a hex driver)
or a mallet-type driver” (Spec. 62:14-19).
FF13. The Specification discloses that “[s]ocket 1620 further includes
an internal tapped hole 1625 formed therein . . . which is configured to
engage a retraction tool” (id. at 62:19-22).
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FF14. The Specification discloses that the “[r]etraction tool 1630
generally comprises … a handle 1640 at one end and a threaded projection
1645 at the other end … [which] is configured for threadable engagement
with internal tapped hole 1625 formed in removable fixation pin 1600” (id.
at 63:3-8).
FF15. Berger discloses a “cannulated, externally and internally
threaded bone screw and a driving device … for use [with the bone screw] in
the reduction and fixation of bone fractures” (Berger, col. 3, ll. 13-15)
FF16. Berger discloses that “internal threading can serve as an
attachment site for the driving device” (id. at col. 3, ll. 19-21).
FF17. Berger discloses that “[b]ecause the screw is secured to the
driver device by a threaded rod … considerable force can be applied to the
unit” (id. at col. 3, ll. 33-37).
Analysis
Claim 85 is directed to a method for revising a graft ligament in a
bone tunnel. The method comprises the steps of, among others, engaging an
internal tapped hole in a transverse fixation pin with a removal tool,
withdrawing the transverse fixation pin from a transverse tunnel with the
removal tool and withdrawing a graft ligament support block from within the
bone tunnel. The Specification discloses that, in a least one embodiment, an
internal tapped hole in a fixation pin is an internally threaded hole capable of
threadable engagement with a retraction tool.
We adopt the finding of facts and reasoning set forth by the Examiner
(Ans. 9-10).
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Appellants contend that the “driver device of Berger is configured to
be locked together with the bone screw to form a bone reduction and fixation
assembly” useful for manipulating bone portions relative to each other (App.
Br. 13). Appellants argue that “it would not have been obvious to modify
the cross-pin of Lombardo to include an internal thread of Berger because
the method of Lombardo does not require any further manipulation of the
assembly once the support block is pinned in place using the cross-pin” (id.
at 14). Appellants argue that “Berger does not disclose the use of the
internally threaded portion of the bone screw to facilitate withdrawal of the
bone screw from bone” (id.).
These arguments are not persuasive. As discussed above, the
combination of Lombardo and Whelan would have made obvious revisions
of graft ligament installment procedures that use a support block and a cross-
pin or transverse fixation pin such that revisions would require removal of
the pin. Berger discloses that internally tapped holes on bone screws can be
used with a driver device to apply considerable force to the bone screw. It
would have been obvious to one of skill in the art to modify the cross-pin of
Lombardo to have an internal tapped hole for engagement with a driver
device (i.e. removal tool) so that force could be applied to the cross-pin for
easy removal from the bone.
Thus, we affirm the rejection of independent claim 85 as being
obvious in view of Lombardo, Whelan, Kim and Berger. Dependent claims
86-88 fall with claim 85. 37 C.F.R. § 41.37(c)(1)(vii).

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Conclusion of Law
The evidence of record supports the Examiner’s conclusion that it
would have been obvious to one of skill in the art to modify Lombardo’s
method to provide an internal tapped hole on the transverse fixation pin for
engagement with a removal tool.
SUMMARY
We affirm the rejection of claims 28-31 under 35 U.S.C. § 112, first
paragraph. We affirm the rejection of claims 22-31, 85-88, 158, and 159
under 35 U.S.C. § 103(a).
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