Ex Parte Picetti et al

Board of Patent Appeals and Interferences

Nov 18, 2009

10313171 (B.P.A.I. Nov. 18, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte GEORGE D. PICETTI,
ANTHONY J. MELKENT, and JOHN STEWART YOUNG
__________

Appeal 2009-004193
Application 10/313,171
Technology Center 3700
__________

Decided: November 18, 2009
__________

Before DEMETRA J. MILLS, LORA M. GREEN, and
FRANCISCO C. PRATS, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for anticipation, obviousness and lack of written description. We
have jurisdiction under 35 U.S.C. § 6(b).

Appeal 2009-004193
Application 10/313,171

STATEMENT OF CASE
The following claims are representative.
4. An apparatus comprising:
a one-piece head portion having two channels, said channels being
configured so that a plurality of elongated members may be connected to
said head via one or more of said channels, and wherein a female thread is
within each of said channels;
a plurality of elongated members connected to said one or more
channels;
wherein said channels are substantially parallel, and said head portion
is substantially W-shaped; and
at least one set screw compatible with said thread connected to said
head portion, said at least one set screw holding at least one of said
elongated members within their respective channels; and
an attachment portion connected to said head portion for connecting
said head portion to a bone.

38. The apparatus of claim 36, wherein said attachment portion is monolithic
with said head portion.

59. The apparatus of claim 4, wherein said head portion includes first,
second and third branches extending in a direction non-parallel to bone
tissue to which said apparatus is to be connected, said first and second
branches defining one of said channels, and said second and third branch
defining the other of said channels.

Cited References
Cotrel US 5,005,562 Apr. 9, 1991
Howland ‘220 US 5,030, 220 Jul. 9, 1991
Howland et al. ‘554 US 5,601,554 Feb. 11, 1997
Errico et al. US 5,688,273 Nov. 18, 1997
Michelson US 6,193,721 B1 Feb. 27, 2001

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Grounds of Rejection
1. Claims 4, 5, 36, 37, 39, 40, 55, and 57 are rejected under 35 U.S.C. §
102(b) as being unpatentable over Michelson.
2. Claims 38, 42, and 58-63 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Cotrel, Howland, Howland, and Errico.
3. Claims 59-61 are rejected under 35 U.S.C. § 112, first paragraph for
failing to comply with the written description requirement.

PRINCIPLES OF LAW
In order for a prior art reference to serve as an anticipatory reference,
it must disclose every limitation of the claimed invention, either explicitly or
inherently. See In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997).
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we considered the factors set forth
in Graham v. John Deere Co., 383 U.S. 1, 17 (1966); (1) the scope and
content of the prior art; (2) the differences between the prior art and the
claims at issue; (3) the level of ordinary skill in the relevant art; and (4)
objective evidence of nonobviousness, if present.
“[O]bviousness requires a suggestion of all limitations in a claim.”
CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003)
(citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).
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The disclosure as originally filed need not provide “in haec verba
support for the claimed subject matter at issue,” rather, the disclosure should
convey to one skilled in the art that the inventor was had possession of the
invention at the time of filing. Purdue Pharma L.P. v. Faulding
Pharmaceutical Co., 230 F.3d 1320, 1323 (Fed. Cir. 2000).

Anticipation
ISSUE
The Examiner argues that Michelson discloses each element
claimed.
Appellants contend that Michelson fails to describe a “one piece head
portion,” a “substantially W-shaped head portion,” and “substantially
parallel channels.” (App. Br. 11, 14.)
The issue is: Have Appellants demonstrated error in the Examiner’s
anticipation rejection?

FINDINGS OF FACT
1. The Examiner finds that
Michelson discloses an apparatus (Figures 63-66) comprising:
a w-shaped one-piece head portion (upper or lower half of 600)
having two substantially parallel female threaded channels
(602) of same width/radius; two elongated members (170) each
passing through a channel (602); two set screws (610) having
external threads to thread into the female threaded channels;
each set screw holding an elongated member in their respective
channel; and a threaded attachment portion (an additional 170;
there are eight in Figure 63) integral and located medially
(could use any of the four centrally located screws in Figure
63) with the head portion.

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(Ans. 4.)
2. The Examiner finds that Michelson teaches a W-shape in Fig. 63. Fig. 63
of Michelson as annotated by the Examiner in the Answer at page 8 is
reproduced below.
.
Figure 63 shows the multilock anterior cervical plating system of Michelson,
as annotated by the Examiner.

ANALYSIS
Appellants contend that Michelson fails to describe a “one piece head
portion,” a “substantially W-shaped head portion,” and “substantially
parallel channels.” We are persuaded by Appellants’ arguments as set forth
in the Brief on pages 11-15.
The Examiner argues that Figure 63 as reproduced herein depicts a
W-shaped head. We are not persuaded. First we do not find that the plate
taught by Michelson would read on a head portion, as one would normally
refer to, for example, the “head” of a screw. Secondly we do not find that
the cervical plating system of Michelson is in the shape of a “W” as claimed.
We find that it is improper for the Examiner to dissect the plate of
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Michelson into a half plate having a longitudinal axis to arrive at a “W”
shape. We agree with Appellants that the shape of Michelson is essentially a
rectangle with ears or bulges at the ends.

CONCLUSION OF LAW
Appellants have demonstrated error in the Examiner’s anticipation
rejection. The anticipation rejection is reversed.

Obviousness
2. Claims 38, 42, and 58-63 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Cotrel, Howland, Howland, and Errico.

ISSUE
The Examiner argues that
Cotrel discloses (Figures 1-9) a device (19) comprising:
a head portion with a channel for receiving a rod (3); the
channel further comprising an internal female threading
portion; the channel is orientated substantially parallel to the
spine; a threaded attachment portion (21) monolithically formed
with the head portion; and a set screw (8) with external threads
complementing the internal threads of the head portion.

(Ans. 5.)

The Examiner admits that Cotrel “fails to disclose or teach a second
channel with the same structure and orientation as the first channel thereby
forming a ‘w-shaped’ head portion with the threaded attachment portion
being medially set between them and a cannulation running through the head
and threaded attachment portion.” (Id.)
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Appellants contend that the one piece head of Cotrel is not W-shaped.
(App. Br. 17.)
The issue is: Has the Examiner provided evidence of a W-shaped
head to support the obviousness rejection.

FINDINGS OF FACT
3. The Examiner finds that
Cotrel discloses (Figures 1-9) a device (19) comprising:
a head portion with a channel for receiving a rod (3); the
channel further comprising an internal female threading
portion; the channel is orientated substantially parallel to the
spine; a threaded attachment portion (21) monolithically formed
with the head portion; and a set screw (8) with external threads
complementing the internal threads of the head portion.

(Ans. 5.)
4. The Examiner finds that “Cotrel fails to disclose or teach a second
channel with the same structure and orientation as the first channel thereby
forming a ‘w-shaped’ head portion with the threaded attachment portion
being medially set between them and a cannulation running through the head
and threaded attachment portion.” (Id.)
5. According to the Examiner, “Howland ('220) teaches the use (Figures 3
and 5) of parallel dual rod devices with the threaded attachment being
medially located (Figures 3, 5, 10-11a).” (Id.)
6. The Examiner finds that
Howland et al ('554) later explained (Column 2, Lines 24-48)
that parallel channels allowed for multiple rods of varying
diameters to be placed (especially important in multi-level
fixation since the spine requires different sized rods in different
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Application 10/313,171

regions) as well as allowing the practitioner to not deform the
spinal rods as much since multiple ones could be utilized).

(Ans. 5.)
7. The Examiner finds that “Errico et al further disclose parallel channels in
their lamina hook (Figure 22) with the reason being (Column 17, Lines 50-
60) that one could be used for temporary alignment for a decurving force
prior to final fixation via the first axis of channels.” (Id.) The Examiner
finds that Errico evidences more or less a W shape. (Id. at 12.)
8. The Examiner argues that,
[I]t would have been obvious to one having ordinary skill in
the art at the time the invention was made to include parallel
channels with a medial located threaded attachment portion in
order to provide for multi-level spinal fixation to allow rods of
varying diameters (of which the rods correspond to the intended
spinal region), to allow for rods to be implanted without a great
degree of bending (surgical difficulty reduced and rod integrity
maintained) and to allow an optional preliminary fixation to
provide a decurving force.

(Id. at 6.)
9. The Examiner argues that “[i]t is well known in the art to provide for
cannulations that receive guidewires in order to accurately place implants
within the body as well as minimizing damage to the surrounding tissue
should the initial locating be less than ideal.” (Id.)
10. The Examiner concludes that “It would have been obvious to one
having ordinary skill in the art to provide for a cannulation extending
through the head portion and threaded portion to allow for a guidewire to
guide the device to an intended location in the body to minimize the
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possibility of poor placement as well as to minimize damage to surrounding
tissue.” (Ans. 6.)

ANALYSIS
Appellants contend that the one piece head of Cotrel is not W-shaped.
(App. Br. 17.) Figure 1 of Cotrel is reproduced below.

Figure 1 of Cotrell shows a u-shaped implant spinal device.
The Examiner admits that Cotrel does not disclose a W-shaped device
and provides no further evidence in the prior art of a W-shaped device, as
claimed. (Ans. 5.) While the Examiner argues that Errico essentially
discloses a W-shape and that one of ordinary skill in the art would have
added a second channel to the device of Cotrel as taught by Errico (Ans. 12),
we are not persuaded that Errico teaches a “w” shaped head, nor that the
references are combinable as suggested by the Examiner.
We agree with Appellants that the Examiner has provided no evidence
of a W-shaped head to support the obviousness rejection and do not agree
with the Examiner’s fact finding that Errico discloses a W-shaped head.
The obviousness rejection is reversed.
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Application 10/313,171

CONCLUSION OF LAW
The Examiner has provided no evidence of a W-shaped head to
support the obviousness rejection. The obviousness rejection is reversed.

Written Description
3. Claims 59-61 are rejected under 35 U.S.C. § 112, first paragraph for
failing to comply with the written description requirement.
Claim 59 recites “wherein said head portion includes first, second and
third branches extending in a direction non-parallel to bone tissue to which
said apparatus is to be connected, said first and second branches defining
one of said channels, and said second and third branch defining the other of
said channels.”
The Examiner argues that claim 59 recites extending in a direction
non-parallel to bone tissue and that because bone extends in all directions it
is unclear how applicant can have a device that is not parallel to bone tissue.
(Ans. 3.)
We are not persuaded. Claim 59 reads that head portion includes first,
second and third branches extending in a direction non-parallel to bone
tissue to which said apparatus is to be connected. Thus, claim 59
provides a reference direction for the bone tissue which is essentially the
direction of the threaded portion of the set screw of the claimed implant.
Appellants argue, and we agree that
[T]he claim gives a particular frame of reference for that
language, and examples are shown in the specification.
Adequate description appears in at least Figures 1-32 and their
accompanying text, which discloses that fixation element 10 is
threaded into a vertebra to accommodate multiple rods used in
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Application 10/313,171

spinal surgery, e.g. a scoliosis correcting surgery on vertebrae
in one or more spinal segment(s). See, e.g., paragraphs 0023-
0025 of the present application as published. The specification
describes implanting element 10 by inserting threaded portion
14 into a vertebra so that head 12 is above the surface of the
vertebra. Thus, it sticks out from the side of the vertebra, and is
not parallel to it or any other part of the spinal column. Rods
are placed in head 12 along or parallel to the vertebral
segment(s) as a correction, and since the branches of head 12
must be substantially perpendicular to the rods (see Fig. I), they
cannot be along or parallel to the vertebral segment(s).

(App. Br. 10.)

Because we find that the claim provides a reference direction
for the bone tissue to which said apparatus is to be connected, one of
ordinary skill in the art would be able to determine a direction non-
parallel to that bone tissue. Thus, one of ordinary skill in the art
would understand that the inventor was had possession of the
invention at the time of filing. The written description rejection is
reversed.
SUMMARY
The written description rejection, anticipation and obviousness
rejections are reversed.
REVERSED

cdc

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