Ex Parte Whittaker

Patent Trial and Appeal Board

May 8, 2014

11311792 (P.T.A.B. May. 8, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte GREGORY R. WHITTAKER
__________

Appeal 2011-012116
Application 11/311,792
Technology Center 3700
__________

Before ERIC GRIMES, LORA M. GREEN, and ERICA A. FRANKLIN,
Administrative Patent Judges.

PER CURIAM.

DECISION ON APPEAL
This is a decision on appeal1 under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 1-6, 8, and 24. We have jurisdiction under
35 U.S.C. § 6(b).
We affirm.

1 The real party in interest is DePuy Mitek, Inc. (App. Br. 2.)
Appeal 2011-012116
Application 11/311,792

2
STATEMENT OF THE CASE
The claims are directed to an implant for replacing an anterior cruciate
ligament in a knee. Claims 1 and 24 are representative of the claims on
appeal and read as follows:
1. An implant for replacing an anterior cruciate ligament in a knee,
the implant comprising:
a) a first fixation member having an axis, a first substantially
cylindrical external surface about the axis, the first surface defining first
external screw threads adapted for threaded engagement with first internal
screw threads formed in a tunnel in a tibia adjacent to the knee, the first
external screw threads having a first major thread diameter and a first minor
thread diameter;
b) a second fixation member having a second substantially cylindrical
external surface about the axis, the second surface defining second external
screw threads adapted for threaded engagement with second internal screw
threads formed in a tunnel in a femur adjacent to the knee, the second
external screw threads having a second major thread diameter and a second
minor thread diameter; and
c) a flexible graft ligament member interconnecting the first fixation
member and the second fixation member.

24. The implant of claim 1 wherein the first fixation member is fixed
within the tunnel in the tibia via the first external screw threads and without
an interference screw.

The claims stand rejected as follows:
• Claims 1-6, 8, and 24 under 35 U.S.C. § 102(b) as anticipated by
Steiner2 (Ans. 4-6);
• Claim 24 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).

2 Steiner et al., US 2003/0171811 A1, published Sept. 11, 2003.
Appeal 2011-012116
Application 11/311,792

3
ANTICIPATION
Issues
Claims 1-6, 8, and 24 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Steiner (Ans. 4-6). Appellant provides separate arguments for
claims 1, 3, 4, and 24. Claims 2, 5, 6, and 8 stand or fall with claim 1, as
they have not been argued separately. 37 C.F.R. § 41.37(c)(1)(vii).
The issues presented by this rejection are as follows:
Has the Examiner established by a preponderance of the evidence that
Steiner discloses an implant with first and second fixation members having
external screw threads adapted for threaded engagement with internal screw
threads formed in bone tunnels, as required by claim 1?
Has the Examiner established by a preponderance of the evidence that
Steiner discloses an implant wherein the first and second fixation members
and the ligament member comprise xenografts, as required by claim 3?
Has the Examiner established by a preponderance of the evidence that
Steiner discloses an implant wherein at least one of the first and second
fixation members is reinforced with a biocompatible material, as required by
claim 4?
Has the Examiner established by a preponderance of the evidence that
Steiner discloses an implant wherein the first fixation member is fixed
within the tunnel of the tibia via the external screw threads and without an
interference screw, as recited by claim 24?
Findings of Fact
FF1. Steiner discloses a “bone-tendon-bone composite graft for use
in tendon and cruciate ligament reconstruction” (Steiner 2, ¶ 0021).
Appeal 2011-012116
Application 11/311,792

4
FF2. Steiner discloses that the graft comprises “allograft bone blocks
. . . pre-machined to form a cylindrical central through going bore and two
longitudinal substantially parallel channels . . . along the outer surface of the
bone block” (id. at 3, ¶ 0021), and a “tendon replacement member . . . is
extended between the bone blocks through the central bore of each bone
block and over an end . . . and back along a parallel channel formed on the
outer surface of each bone block” (id.).
FF3. Steiner discloses that “a bone tunnel is drilled in[to] each of two
bones of [a] joint” (id. at 2, ¶ 0021), e.g., a femur and a tibia (id.), and
“[e]ach bone block is inserted into one of the bone tunnels and secured
therein by an interference screw which [is] inserted into the other channel
formed on the outside surface of the bone block” (id. at 3, ¶ 0021).
FF4. Steiner discloses that a “plurality of shaped teeth 139 are cut
into the outer surface [of the bone block] . . . to provide additional gripping”
in the bone tunnel (id. at 5, ¶ 0055).
FF5. Steiner further discloses that it is “within the scope of the
invention to stagger the rows of teeth . . . or to apply a thread or ridge on the
outside exterior surface” (id.).
FF6. Steiner’s Figure 16 is shown below:

Figure 16 shows “a perspective view of the alternate embodiment of the
inventive bone block with an exterior thread” (id. at 3, ¶ 0045).
Appeal 2011-012116
Application 11/311,792

5
FF7. Steiner discloses that “alternative sources of bone blocks may
be substituted such as xenograft bone or synthetic graft materials” (id. at 5, ¶
0061). Further, Steiner discloses implants wherein the ligament is xenograft
tissue (id. at 8, claim 32).
FF8. Steiner discloses that “medically useful substances can be
incorporated in the bone block and tendon assembly by adding the
substances to the assembly. Such substances include collagen and . . .
hydroxyapatite,” among others (id. at 6, ¶ 0067).
FF9. The present Specification discloses that “[p]reparation of the
implant may also include reinforcing one or both bone blocks with a
biocompatible material such as a bone cement, an apatite composition, or a
curable polymeric material” (id. at 9, ¶ 0036).
Principles of Law
“[A]nticipation requires that all of the elements and limitations of the
claim are found within a single prior art reference.” Scripps Clinic &
Research Found. v. Genentech, Inc., 927 F.2d 1565, 1576 (Fed. Cir. 1991).
“[A]pparatus claims cover what a device is, not what a device does.”
Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed.
Cir. 1990). Claims directed to an apparatus must be distinguished from the
prior art on structural grounds. See In re Schreiber, 128 F.3d 1473, 1477-
1478 (Fed. Cir. 1997). “[T]he patentability of apparatus or composition
claims depends on the claimed structure, not on the use or purpose of that
structure.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d
801, 809 (Fed. Cir. 2002).
Appeal 2011-012116
Application 11/311,792

6
Discussion
The Examiner finds that Steiner discloses “an implant for replacing an
anterior cruciate ligament in a knee” (Ans. 4). The Examiner finds, in
relevant part, that Steiner’s implant comprises first and second fixation
members (i.e., bone blocks or plugs)3 having substantially cylindrical
external surfaces (id. at 4-5), and “a flexible graft ligament member 50 . . .
interconnecting the first fixation member and the second fixation member”
(id. at 5). The Examiner finds that Steiner discloses “applying threads to the
outside of the bone [block]” (id. at 4), and further finds that “the external
threads of the plug are fully capable of performing the function of engaging
first internal screw threads formed in a [bone] tunnel” (id. at 4-5).
The Examiner also finds that Steiner teaches that the bone blocks of
the implant may comprise allograft or xenograft material, and the ligament
may comprise xenograft tissue (id. at 5). The Examiner further finds that the
bone blocks may be reinforced with a biocompatible material (id.), e.g.,
hydroxyapatite (id. at 9).
Claim 1
Appellant argues that claim 1 defines an implant having first and
second fixation members that each “have external threads adapted for
threaded engagement with internal screw threads formed in a tunnel in a
tibia and femur respectively” (App. Br. 3). Appellant argues that “Steiner

3 Steiner uses the term “bone plug” in discussing the background of its
invention (Steiner 2, ¶ 0018), and the term “bone block” in discussing its
invention (id. at 3, ¶ 0021). The Examiner uses the terms “bone block” and
“bone plug” interchangeably, and to correspond to the term “fixation
member” in the present claims.
Appeal 2011-012116
Application 11/311,792

7
discloses a conventional BTB (Bone-Tendon-Bone) implant . . . [in which]
[t]wo bone implants . . . are fixed within respective tibial and femoral
tunnels via interference screws adjacent the implants” (id.). Appellant
argues that Steiner does not teach “threading the implants into the bone . . .
[rather] the Steiner implants are held in place by a compression screw that
presses it against the adjacent bone wall” (id.). Appellant argues that Steiner
provides “[p]urchase enhancements . . . in the form of teeth or ridges which
supply additional gripping” (id. at 3-4), and “the mention of threads by
Steiner represents merely one additional manner in providing a purchase
enhancement to the implant, similar to . . . teeth or ridges . . . [but the
implant] is still meant to be held in place by a separate interference screw”
(id. at 4).
Appellant’s argument is not persuasive. It is well settled that “the
patentability of apparatus . . . claims depends on the claimed structure, not
on the use or purpose of that structure.” Catalina Mktg., 289 F.3d at 809.
As pointed out by the Examiner, claim 1 is directed to an implant, i.e., an
apparatus, “with a certain physical structure” (Ans. 7). Specifically, claim 1
is directed to an implant comprising fixation members (i.e., bone blocks)
with external screw threads “adapted for threaded engagement with . . .
internal screw threads formed in a [bone] tunnel in a tibia [or femur]
adjacent to the knee” (claim 1). Appellant concedes that the threads on
Steiner’s bone blocks “provid[e] a purchase enhancement to the implant”
(App. Br. 4). Regardless of whether Steiner’s implant is meant, or intended,
to be held in place with an interference (or compression) screw, Appellant
has not explained why the external threads on Steiner’s bone blocks would
Appeal 2011-012116
Application 11/311,792

8
be incapable of engagement with internal screw threads formed in bone
tunnels prepared to receive the bone blocks.
A preponderance of the evidence of record supports the Examiner’s
finding that Steiner discloses an implant with first and second fixation
members having “external screw threads adapted for threaded engagement
with” internal screw threads formed in bone tunnels, as required by claim 1.
Accordingly, the rejection of claim 1 as anticipated by Steiner is affirmed,
and claims 2, 5, 6, and 8 fall with claim 1 as they were not separately
argued. 37 C.F.R. § 41.37(c)(1)(vii).
Claim 3
Appellant contends that claim 3, which depends from claim 1,
“provides that the first and second fixation members . . . and the ligament
member are xenograft” (App. Br. 4), but “Steiner lacks such a teaching”
(id.).
Appellant’s argument is not persuasive. As noted by the Examiner,
Steiner (¶ 0061 and claim 7) discloses that both the first and second bone
block may be constructed of xenograft cortical bone, and (claim 32)
discloses xenograft tissue as a ligament component (Ans. 5; FF 7).
The rejection of claim 3 as anticipated by Steiner is affirmed.
Claim 4
Appellant contends that claim 4, which depends from claim 1, further
requires that “at least one of the [first and the second fixation member] is
reinforced with a biocompatible material” (App. Br. 4), but the “Examiner
has failed to articulate how Steiner teaches such a structure” (id.).
Appeal 2011-012116
Application 11/311,792

9
This argument is not persuasive. The present Specification (¶ 0036)
discloses that a reinforcing material may be apatite, among others, and
Steiner (¶ 0067) discloses that hydroxyapatite may be added to the bone
grafts (FFs 8, 9).
The rejection of claim 4 as anticipated by Steiner is affirmed.
Claim 24
Finally, Appellant argues that claim 24, which depends from claim 1,
further requires that “the first fixation member is fixed within the tunnel in
the tibia via the first external screw threads and without an interference
screw” (App. Br. 5), but “Steiner only teaches fixation members fixed into
tunnels with interference screws” (id.).
We are not persuaded. As discussed above, the claims are directed to
an implant, i.e., an apparatus, comprising a fixation member with “external
screw threads adapted for threaded engagement with . . . internal screw
threads formed in a tunnel” (claim 1) in a bone prepared to receive the
implant. Although claim 24 recites that the fixation member is fixed in the
tunnel via the external screw threads “and without an interference screw,”
this is merely a recitation of an intended use for the implant. Appellant has
not distinguished the claimed implant from Steiner’s implant on structural
grounds. See Schreiber, 128 F.3d at 1477-1478.
The rejection of claim 24 as anticipated by Steiner is affirmed.
Accordingly, a preponderance of the evidence of record supports the
Examiner’s finding that Steiner anticipates all of the claims on appeal.

Appeal 2011-012116
Application 11/311,792

10
NEW MATTER
Issue
Claim 24 stands rejected under 35 U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement. As discussed
above, claim 24 requires that “the first fixation member is fixed within the
tunnel in the tibia via the first external screw threads and without an
interference screw.”
The issue raised by this rejection is whether the evidence of record
supports the Examiner’s finding that the “negative limitation ‘without an
interference screw’” is new matter. (Ans. 4.)
Principles of Law
“In order to satisfy the written description requirement, the disclosure
as originally filed does not have to provide in haec verba support for the
claimed subject matter at issue.” Purdue Pharma L.P. v. Faulding, Inc.,
230 F.3d 1320, 1323 (Fed. Cir. 2000). Rather, the disclosure must convey
with reasonable clarity to those skilled in the art that the inventor was in
possession of the invention. See id.
Moreover, when alternative elements are positively recited in the
Specification, they may be explicitly excluded in the claims. See In re
Johnson, 558 F.2d 1008, 1019 (CCPA 1977).
Discussion
According to the Examiner, the “negative limitation ‘without an
interference screw’” is new matter, as it “does not have basis in the
specification to show support that the fixation member has to be used
without an interference screw” (Ans. 4).
Appeal 2011-012116
Application 11/311,792

11
Appellant contends that “FIG. 1 and the description of the
implantation of a similar device in paragraphs [0054] and [0055] describe[ ]
the claimed invention, without the use of an interference screw . . . [that] is
in contrast to FIG. 7 in which an interference screw is employed” (App. Br.
3). Appellant argues that this disclosure clearly shows possession of “the
idea of implantation without the separate interference screw” (id.).
The Examiner responds that “the disclosure in Fig. 1 and paragraphs
0054 and 0055 do not provide any support or discussion for whether or not
an interference screw is present” (Ans. 6). The Examiner further notes that
paragraph 0038 of the Specification discloses that “fixation of the implant
100 in a threaded bone tunnel requires as fixation means only the external
threads 118, 126 fashioned from the material of respective bone blocks”
(id.), and finds that this “disclosure positively discloses how the structure is
fixated in the bone tunnel . . . [but] does not provide support for the negative
limitation of ‘without an interference screw’” (id. at 7).
We do not find the Examiner’s position persuasive. The Examiner
acknowledges that the Specification discloses an implant that “requires as
fixation means only the external threads . . . fashioned from the material of
respective bone blocks” (Ans. 6). We note, moreover, that the Specification
discloses “another embodiment, [depicted in Figure 7, wherein] the proximal
fixation member 306 is a conventional bone block fixed in place in the
second bone tunnel 308 by inserting an interference screw 320 between the
bone block and a wall 322 of the second bone tunnel 308” (Spec. 13, ¶ 45).
We find, therefore, that the Specification conveys with reasonable clarity
that Appellant was in possession of alternative embodiments: an implant
Appeal 2011-012116
Application 11/311,792

12
meant to be fixed with an interference screw, and an implant meant to be
fixed by external threads alone, i.e., fixed without an interference screw.
We find that the preponderance of the evidence of record supports
Appellant’s contention that the Specification provides adequate written
descriptive support for the recitation “without an interference screw” in
claim 24. The rejection of claim 24 as lacking written descriptive support is
reversed.
SUMMARY
We affirm the rejection of claims 1-6, 8, and 24 under 35 U.S.C.
§ 102(b).
We reverse the rejection of claim 24 under 35 U.S.C. § 112, first
paragraph.
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

cdc