Ex Parte Randol et al

Patent Trial and Appeal Board

Feb 1, 2019

12053924 (P.T.A.B. Feb. 1, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/053,924 03/24/2008
23908 7590 02/05/2019
RENNER OTTO BOISSELLE & SKLAR, LLP
1621 EUCLID AVENUE
NINETEENTH FLOOR
CLEVELAND, OH 44115
FIRST NAMED INVENTOR
David Scott Randol
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.
INGNP0102US 5190
EXAMINER
JOHANAS, JACQUELINE T
ART UNIT PAPER NUMBER
3773
NOTIFICATION DATE DELIVERY MODE
02/05/2019 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
ipdocket@rennerotto.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID SCOTT RANDOL,
DAVID A. WALSH, and CARL ARTHUR KNOBLOCH
Appeal2017-008825 1
Application 12/053,924
Technology Center 3700
Before FRANCISCO C. PRATS, JOHN G. NEW, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to rods used in
spinal stabilization. The Examiner rejected the claims for indefiniteness and
obviousness.
We have jurisdiction under 35 U.S.C. § 6(b ).
We reverse the Examiner's rejection for indefiniteness, but affirm the
Examiner's obviousness rejections.
1 Appellants identify V ertebrod, LLC as the real party in interest. Appeal
Br. 2.
Appeal2017-008825
Application 12/053,924
STATEMENT OF THE CASE
Appellants' invention "relates to novel stabilization rods for use with
locking mechanisms for spine stabilization." Spec. ,r 24.
Preferably, the stabilization rods of Appellants' invention allow a
"metal to metal contact surface between the rod and locking mechanism
while exhibiting bending properties that are different than a metal rod of the
same size. This may be accomplished through a variety of designs, each of
which includes a rod made of both metal and elastomeric material." Id.
For example, rods composed of a combination of a titanium alloy and
an elastomeric material are more flexible than rods composed of only the
alloy, or other materials. See id. ,r 4 7 ("As can be seen in Figure 8, the
[inventive] rod 100 shows more flexibility than the titanium and carbon
filled PEEK [Poly Ether Ether Keytone] rods tested.").
Claim 85 illustrates the subject matter on appeal, and reads as follows:
85. A rod comprising:
a metal structure having:
an elongated channel having a length in a direction
generally parallel to a major axis of the metal structure
and extending into a radial surface of the metal structure
in a direction generally orthogonal to a major axis of the
metal structure but not extending entirely through an
opposite radial surface of the metal structure, and
at least one minor axis channel extending into a
radial surface of the metal structure in a direction
generally orthogonal to the major axis of the structure,
wherein at least one of the at least one minor axis
channel passes entirely through opposing sides of the
elongated channel and resides entirely within the length
of the elongated channel;
an elastomeric material at least partially filling a region
where at least one of the at least one minor axis channel passes
through the elongated channel;
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wherein the rod is adapted to be received by a locking
mechanism comprising a body and a screw, the body being
adapted to receive the rod and the screw being adapted to
engage a bone without passing through the rod, and the locking
mechanism being adapted to fix the rod in space with respect to
the screw such the screw does not pass through the rod.
Appeal Br. 54 (Claims App.).
The following rejections are before us for review:
(1) Claims 86 and 98, under 35 U.S.C. § 112, second paragraph, as
being indefinite (Ans. 2);
(2) Claims 85 and 87-96, under 35 U.S.C. § I03(a) as being
unpatentable over Harle2 and Smaldone3 (Ans. 3---6),
(3) Claim 86, under 35 U.S.C. § I03(a) as being unpatentable over
Harle, Smaldone, and Jacobson4 (Ans. 6-7);
(4) Claims 97 and 99-106, under 35 U.S.C. § I03(a) as being
unpatentable over Harle and Smaldone (Ans. 7-10);
(5) Claim 98, under 35 U.S.C. § I03(a) as being unpatentable over
Harle, Smaldone, and Jacobson (Ans. 11);
(6) Claims 107-114, under 35 U.S.C. § I03(a) as being unpatentable
over Harle, Smaldone, and Martinez5 (Ans. 12-15); and
(7) Claims 115-121, under 35 U.S.C. § I03(a) as being unpatentable
over Harle, Smaldone, and Martinez (Ans. 15-19).
2 Harle, US 4,297 ,9931; issued Nov. 3, 1981 (hereinafter "Harle").
3 Smaldone et al., US 2005/0211245 Al; published Sep. 29, 2005,
(hereinafter "Smaldone").
4 Jacobson et al., US 5,382,248; issued Jan. 17, 1995, (hereinafter
"Jacobson").
5 Martinez et al., US 2007/0016190 Al; published Jan. 18, 2007 (hereinafter
"Martinez").
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Application 12/053,924
STANDARD OF REVIEW
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he [E]xaminer bears the initial burden ... of presenting a
prima facie case of unpatentability ....
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
INDEFINITENESS-CLAIMS 86 AND 98
The Examiner's Prima Facie Case
In rejecting claims 86 and 98 for indefiniteness, the Examiner noted
that those claims depend, respectively, from independent claims 85 and 97,
both of which recite "[a] rod." Ans. 2.
The Examiner concluded that claims 86 and 98 are indefinite because
claims 86 and 98 do not recite components of a rod, but instead recite an
additional feature, a locking mechanism, which is not part of a rod. See id.
("A rod only includes elements that constitute a rod.").
In particular, the Examiner concluded that "[ c ]laim 86 suggests a
system ( combination of a rod and locking mechanism), while parent claim
85 claims an apparatus; as such the claims are inconsistent and indefinite.
Claim 98 is indefinite for the same reasons as claim 86." Id.
Analysis
A claim does not comply with 35 U.S.C. § 112, second paragraph,
"when it contains words or phrases whose meaning is unclear." In re
Packard, 751 F.3d 1307, 1310-1314 (Fed. Cir. 2014) (approving, for pre-
issuance claims, the standard from MPEP § 2173.05(e)); see also Ex parte
McAward, Appeal 2015-006416, 2017 WL 3669566, at *5 (PTAB Aug. 25,
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Application 12/053,924
2017) (precedential) (adopting the approach for assessing indefiniteness
approved by the Federal Circuit in Packard).
That is, "claims are required to be cast in clear-as opposed to
ambiguous, vague, indefinite-terms." Packard, 751 F.3d at 1313; see also
Nautilus, Inc. v. Biosig, Instruments, Inc., 134 S.Ct. 2120, 2129 (2014) ("[A]
patent must be precise enough to afford clear notice of what is claimed,
thereby 'apprising the public of what is still open to them."').
In the present case, having carefully considered all of the arguments
and evidence advanced by Appellants and the Examiner, Appellants
persuade us that the scope of the subject matter encompassed by claims 86
and 98 is clear and unambiguous. We acknowledge, as the Examiner
determined, that the preambles of claims 85 and 97 both recite "[a] rod."
Appeal Br. 54, 56 (Claim App.).
We acknowledge, as the Examiner also determined, that each of
dependent claims 86 and 98 recites that the rod of the preceding independent
claim "further compris[ es] a locking mechanism" having a number of
features. Id. at 55, 57 (Claim App.).
We agree with Appellants, however, that based on the language in the
claims, it is clear and unambiguous that claims 86 and 98 recite an assembly
composed of the rod recited in claims 85 and 97, respectively, and the
locking mechanisms recited in claims 86 and 98.
As to the concern that appears to underlie the Examiner's rejection,
we note that, elsewhere in their claims, Appellants perhaps more accurately
use the term "fixation assembly" in the preamble of a claim directed to a
combination of a rod and locking mechanism. See id. at 59 (Claim App.);
(see claim 107).
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Application 12/053,924
That fact, however, does not persuade us that the scope of claims 86
and 98 is unclear. We, therefore, reverse the Examiner's indefiniteness
rejection.
OBVIOUSNESS-CLAIMS 85 AND 87-96
The Examiner's Position
In rejecting claims 85 and 87-96 for obviousness, the Examiner cited
Harle as disclosing a rod having all of the structural elements required by the
claims, including being composed of a combination of metal and a second
non-metal material. Ans. 3. The Examiner noted that Harle disclosed the
non-metal material of its rod as being "a carrier material adapted to release
antibiotics ([see A ]bstract)." Id. at 4.
The Examiner conceded that the rod described by Harle differed from
the rod recited in the rejected claims in that "Harle does not disclose that the
[ non-metal antibiotic carrier] material is an elastomer per se." Id.
The Examiner cited Smaldone as evidence that it was known in the art
to use an antibiotic-containing elastomeric material as a coating for medical
devices. Id. ( citing Smaldone ,r 154).
Based on the references' combined teachings, the Examiner
concluded that it would have been obvious "to make the [antibiotic] carrier
material of the rod of Harle an elastomeric polymer, as taught by Smaldone,
so as to provide long-duration release of antibiotics from the rod." Id.
Analysis
Claim 85 is representative of the claims subject to this ground of
rejection. 37 C.F.R. § 4I.37(c)(l)(iv). Having carefully considered all of
the arguments and supporting evidence advanced by Appellants and the
Examiner, Appellants do not persuade us that the preponderance of the
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Application 12/053,924
evidence fails to support the Examiner's conclusion of obviousness as to
claim 85 over Harle and Smaldone. To the contrary, we discern no error in
the Examiner's findings of fact as to the cited prior art, nor are we persuaded
of error in the Examiner's conclusion of obviousness based thereon.
We acknowledge, but are unpersuaded by, Appellants' contentions
that the combined teachings of Harle and Smaldone would have failed to
motivate a skilled artisan to use an elastomeric material as the antibiotic-
bearing material in Harle's device. See App. Br. 10-14; see also Reply Br.
2-8.
Harle discloses an "aid for osteosynthesis, such as a plate, nail or
screw, made of a material having appropriate strength .... Such aids for
osteosynthesis, especially metallic aids, serve for the inner fixation of a
fracture." Harle, 1:4--10.
Harle discloses that, in addition to fracture fixation, its aid for
osteosynthesis, e.g., the plate, "is used as a carrier for a long-acting
antibiotic, there being no change in the surface of this aid even after a
prolonged period," which "is achieved by the application of antibiotics
uniformly distributed in a non-reabsorbable carrier material of a constant
surface form on the surface of the aid for osteosynthesis." Id. at 2:7-9.
Harle discloses that the "carrier material including the antibiotic
distributed therein can be completely or partially coated onto the surface of
the aid. An alternative embodiment is characterized by receiving spaces
which are open to the outside of the aid which serve to receive and hold the
carrier material including the antibiotics." Id. at 2:24--29.
Harle discloses that a "suitable carrier material is for instance a
cement such as used in connection with the implantation of pro[s]theses or
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Application 12/053,924
the like sofar it allows the protracted release of the antibiotics." Id. at 2:29--
33.
Harle discloses a specific embodiment, depicted in its Figures 3 and 6,
directed to a bone plate, "which is made of metal in the illustrative examples
shown" (id. at 3:47--48), and which includes antibiotic-bearing carrier
material located in channel shaped recesses 8 and 10 along the longitudinal
axis of the plate in the plate, as well as the outer edges 11 and 12 of the
plate. Id. at 3:39--47.
Figures 2, 3, 5, and 6 of Harle are reproduced below:
FIG.2
FIG.5
n
m~ lJ,' <~
10 12 9
FIG.3
FIG.6
14
'
Figures 2 and 5 of Harle show a bone plate including channel shaped
recesses 8 and 10 and outer edges 11 and 12 along the outer of the bone
plate. Figures 3 and 6 show the same bone plate with carrier material 14
located in the channels 8 and 10 and also coated on the outer edges 11 and
12.
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Application 12/053,924
As the Examiner found, Harle differs from Appellants' claim 85 in
that Harle does not expressly disclose that the material filling the channels is
an elastomeric material. Smaldone, however, discloses that when coating a
medical device with a non-bioerodible, antibiotic-bearing material that
provides long-term antibiotic release, elastomeric materials were useful as
the antibiotic carrier.
Specifically, Smaldone discloses "an endotracheal tube or
tracheostomy tube impregnated with one or more antimicrobials .... In one
embodiment, the antibiotic mixture may be applied as a surface coating of
the endotracheal tube." Smaldone ,r 153.
Smaldone discloses that "[p ]olymer surface coatings are known to
provide long-duration release of antibiotics and other drugs from polymer
surface coatings." Id. ,r 154.
Smaldone discloses that useful polymers "form a uniform, solid,
complex" with the impregnated antibiotic, and "are both biocompatible and
nonbioerodible." Id. Among polymers suitable for its purposes, Smaldone
lists "elastomeric organosilicon polymers." Id.
Given Harle's teachings that it was desirable to coat a bone fracture-
stabilizing device with an antibiotic-containing, non-reabsorbable coating
that provided long-term antibiotic release, viewed in light of Smaldone's
disclosures that an elastomeric material was useful for coating a medical
device with a non-bioerodible, antibiotic-bearing material that provides
long-term antibiotic release, we agree with the Examiner that an ordinary
artisan had a good reason for coating Harle' s device with an elastomeric
material as taught by Smaldone. See KSR International Co. v. Teleflex Inc.,
550 U.S. 398, 416 (2007) ("[W]hen a patent claims a structure already
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Application 12/053,924
known in the prior art that is altered by mere substitution of one element for
another known in the field, the combination must do more than yield a
predictable result."). Thus, because an ordinary artisan would have
recognized that Smaldone' s elastomeric material would provide not only the
long-term antibiotic release desired by Harle, but also the non-bioerodible
properties sought by Harle, Appellants do not persuade us that a skilled
artisan lacked motivation for using Smaldone's antibiotic-impregnated
elastomeric material as the antibiotic coating material for Harle's device.
We acknowledge Harle's teaching, identified by Appellants (Appeal
Br. 13; see also Reply Br. 4--5), that Harle' s antibiotic carrier material
should have the capacity to be roughened, in certain instances:
According to a further essential characteristic of the
invention, it is furthermore proposed that the outside of the
actual carrier material can also be roughened in order thus to
ensure better fixation by new formation of bone at the surface
of the implant. This measure is particularly important in the
case of implants, for example in artificial joints.
Harle, 2:42--48.
As the Examiner points out, however, rather than describing the
capacity to be roughened as an essential property of its antibiotic carrier
material, Harle elsewhere discloses the roughening property as an optional
feature of a particular embodiment. See id. at Abstract ("The outside of the
carrier may be roughened to improve fixation of the bone or tissue.")
(emphasis added), 4:3---6 ("The possibility for roughening the outside of the
carrier material is shown in FIG. 3. This measure is particularly meaningful
if an artificial joint or similar implant is to be furnished in accordance with
the proposal of the invention.") (emphasis added).
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Application 12/053,924
Thus, viewing the reference as a whole, we agree with the Examiner
that the capacity to be roughened is not an essential requirement of Harle' s
antibiotic carrier. Moreover, given Smaldone's description, noted above, of
its antibiotic carrier as being a solid complex of non-bioerodible material,
we find that Smaldone provides sufficient disclosure suggesting not only the
use of Smaldone' s carrier as the carrier material for Harle' s device, but also
the roughening capacity of Smaldone' s carrier material.
As to Appellants' argument in the Reply Brief that Smaldone' s
elastomeric materials were known to be compatible only with soft tissue,
and were known also to be incompatible with bone because of the potential
for bone degradation such as osteolysis (see Reply Br. 6-7), we first note
that Appellants do not cite any specific evidence in support of this assertion.
We are not persuaded, moreover, that this new argument is properly
presented for the first time in the Reply Brief. As explained in 37 C.F.R.
§ 4I.37(c)(l)(iv), except in certain circumstances not applicable here, "any
arguments or authorities not included in the appeal brief will be refused
consideration by the Board for purposes of the present appeal." We are not
persuaded, therefore, that this new argument is properly presented for the
first time in the Reply Brief, such that we should consider it. See 37 CPR
§ 41.41 (b )(2) ("Any argument raised in the reply brief which was not raised
in the appeal brief, or is not responsive to an argument raised in the
examiner's answer, including any designated new ground of rejection, will
not be considered by the Board for purposes of the present appeal, unless
good cause is shown."); see also Ex parte Borden, 93 USPQ2d 1473, 1477
(BP AI 2010) (The reply brief is not "an opportunity to make arguments that
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Application 12/053,924
could have been made in the principal brief on appeal to rebut the
Examiner's rejections, but were not.") (informative).
We acknowledge, but are unpersuaded by, Appellants' contentions
and supporting testimony in the Baker Declaration, 6 that under In re
Giannelli, 739 F.3d 1375 (Fed. Cir. 2014), the "adapted to" language in
Appellants' claim 85 (see Appeal Br. 54) is sufficient to distinguish the
claimed rod from the bone plate disclosed in Harle. See Appeal Br. 14--28.
In Giannelli, our reviewing court considered whether the Board erred
in concluding that a claim directed to a rowing exercise machine including a
"first handle portion adapted to be moved from a first position to a second
position by a pulling force ... in a rowing motion" was obvious over a chest
press machine. Giannelli, 739 F.3d at 1379.
In determining that the Board erred in finding the claim obvious, the
court in Giannelli found that the written description supporting the claim at
issue included specific "structural attributes" that enabled performing the
rowing motion required by the "adapted to" language in the claim. Id. at
13 80 ("The location of those handles [ disclosed in the supporting disclosure]
relative to the other components is one of their structural attributes that
enables performance of the rowing motion against the selected resistance.").
Consequently, the court determined, rather than broadly interpreting
the "adapted to" language as encompassing a machine "capable of' the
rowing motion recited in the claim, the "adapted to" language should have
been more narrowly interpreted encompassing a device "designed or
constructed to be used as a rowing machine whereby a pulling force is
6 Declaration of Daniel R. Baker, Ph.D., signed March 7, 2016 ("Baker
Deel.").
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Application 12/053,924
exerted on the handles." Giannelli, 739 F.3d at 1379, 1380 ("[T]he relevant
question before the Board was whether the apparatus described in the [prior
art] '447 patent was 'made to,' 'designed to,' or 'configured to,' allow the
user to perform a rowing exercise by pulling on the handles as claimed in the
'261 application.") ( quotations omitted).
In the present case, Appellants' claim 85 recites that
the rod is adapted to be received by a locking mechanism
comprising a body and a screw, the body being adapted to
receive the rod and the screw being adapted to engage a bone
without passing through the rod, and the locking mechanism
being adapted to fix the rod in space with respect to the screw
such the screw does not pass through the rod.
Appeal Br. 54 (Claims App.).
We acknowledge, as Appellants contend, that the Specification, in a
number of instances, states that the disclosed rod is to be used as part of an
assembly that includes a locking mechanism. See id. at 19 ( citing Spec. ,r,r
1, 5, 25, and Fig. 8); see also Baker Deel. ,r 18 (same).
Neither Appellants nor Dr. Baker, however, identify any disclosure in
the Specification of specific structural or design attributes of the disclosed
rod that distinguish that rod from the plate device disclosed in Figures 3 and
6 of Harle, reproduced above. To the contrary, rather than disclosing a rod
with a particular structure, configuration, or structural attribute that allows it
to be received by a locking mechanism, Appellants' disclosure describes the
rod as having any number of different shapes, including a simple cylindrical
shape (Fig. IA), an I-beam shaped cross-section (Fig. 4), and a star-shaped
cross-section (Fig. 5). See Spec. ,r 39 (locking mechanism contact surface
may be flat or tapered).
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Application 12/053,924
We note, in particular, that the rod having and I-beam shaped cross-
section of Appellants' Figure 4 is similar in shape to the plate device shown
in Harle's Figures 3 and 6, and that Harle's plate device has at least two flat
surfaces that would accommodate a locking mechanism as described in the
Specification. See Harle, Figs. 3 and 6. Because Appellants do not identify,
nor do we discern, any specific structural attributes possessed by the rod
disclosed and claimed by Appellants, we are not persuaded that the "adapted
to" language distinguishes Harle's plate device from the rod recited in
Appellants' claim 85.
As Dr. Baker concedes, moreover, Harle's device could physically fit,
i.e., be received by, a locking mechanism as required by claim 85. See
Baker Deel. ,r 40.
We acknowledge Dr. Baker's assertion that, despite its capability of
being received in a locking mechanism, Harle' s plate device is unsuitable for
spinal fixation:
[T]he structure of Harle is specifically designed to have
mechanical properties suitable for its function as a fixation
plate. If one were to attempt to use such a structure for the
purpose of the rod in [Appellant's Specification], it would
undoubtedly fail due to fatigue, loading, bending, crushing, etc.
Moreover, because [Appellants' device] is directed to spinal
fixation, the failure of the plate (used as a rod) would cause
damage to the spinal column, likely causing paralysis, or worse
Id. ,I 41.
Dr. Baker, however, does not identify any specific evidence
supporting the assertion that Harle' s device would fail or cause spinal
damage if used for spinal fixation. To the contrary, Harle broadly discloses
that its fracture fixation device may be constructed "of a material having
appropriate strength." Harle 1:5---6.
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Moreover, evidence advanced by Appellants supports a finding that
both plates and rods may be used in spinal fixation. See, e.g., An 7 at 78
("Recently, various fixation devices using pedicle screws and plates (or
rods) have been introduced. Regardless of the type of longitudinal linkage
connecting the pedicle screws, intrapedicular fixation was known to provide
sufficient rigidity.") (emphasis added); see also Aebi, 8 10 ("Following
decompression and anterior column reconstruction, the system can be
converted from an unconstrained into a constrained system during surgery,
utilizing either a rigid-plate screw system (ATLP) or a double rod and screw
system (USS Ventrofix).") (emphasis added).
The Thramann, 9 reference cited by the Examiner similarly discloses
that both plates and rods may be used in spinal fixation. Thramann, Abstract
("A dynamic spinal stabilization apparatus comprises a stabilization device
such as a rod or a plate.") (emphasis added). Thus, that Harle characterizes
its fixation device as a plate does not persuade us that Appellants' claim 85,
including the claim's "adapted to" language, fails to encompass Harle's
device.
In sum, for the reasons discussed, Appellants do not persuade that the
preponderance of the evidence fails to support the Examiner's conclusion of
obviousness as to Appellants' claim 85. We, therefore, affirm the
Examiner's rejection of claim 85 over Harle and Smaldone. Because they
7 Howard S. An., M.D., Principles and Techniques of Spine Surgery, 78
(1998).
8 M. Aebi et al., AO ASIF Principles in Spine Surgery, IO (1998)
(hereinafter "Aebi").
9 Thramann et al., US 2007/0161997 Al; published July 12, 2007
(hereinafter "Thramann").
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were not argued separately, claims 87-96 fall with claim 85. 37 C.F.R.
§ 4I.37(c)(l)(iv).
OBVIOUSNESS-CLAIM 86
The Examiner's Prima Facie Case
In rejecting claim 86, which depends from claim 85 discussed above,
for obviousness over Harle, Smaldone, and Jacobson, the Examiner relied on
the teachings in Harle and Smaldone discussed above, and cited Jacobson as
evidence that it would have been obvious to combine a locking mechanism
as recited in claim 86, with the rod recited in claim 85. See Ans. 6-7.
Analysis
Appellants do not direct specific argument to the Examiner's
combination of Harle, Smaldone, and Jacobson, but instead argue only that
"[ c ]laims 86-96 depend from independent claim 85 and are allowable for at
least the same reasons discussed with respect to claim 85." Appeal Br. 28.
As discussed above, we do not find Appellants' arguments regarding
claim 85 persuasive. Accordingly, because Appellants do not identify, nor
do we discern, error in the Examiner's conclusion of obviousness as to claim
86, we affirm the Examiner's rejection of claim 86 over Harle, Smaldone,
and Jacobson.
OBVIOUSNESS-CLAIMS 97 AND 99-106
The Examiner's Prima Facie Case
In rejecting claims 97 and 99-106 over Harle and Smaldone, the
Examiner relied on a rationale similar to that discussed above as to claim 85.
Specifically, as to independent claim 97, as with claim 85, the Examiner
concluded that it would have been obvious "to make the carrier material of
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the rod of Harle an elastomeric polymer, as taught by Smaldone, so as to
provide long-duration release of antibiotics from the rod." Ans. 9.
Analysis
Claim 97, the sole independent claim subject to this ground of
rejection, is representative. 37 C.F.R. § 4I.37(c)(l)(iv). Having carefully
considered all of the arguments and supporting evidence advanced by
Appellants and the Examiner, Appellants do not persuade us that the
preponderance of the evidence fails to support the Examiner's conclusion of
obviousness as to claim 97 over Harle and Smaldone. To the contrary, we
discern no error in the Examiner's findings of fact as to the cited prior art,
nor are we persuaded of error in the Examiner's conclusion of obviousness
based thereon.
Claim 97 recites a rod similar to that recited in claim 85 discussed
above, and similar to claim 85 discussed above, claim 97 recites that the
claimed rod "is adapted to be received by a locking mechanism comprising a
screw in which elements of the locking mechanism on opposing sides of the
rod apply compressive force to generally opposing sides of the rod, thereby
fixing the rod in space with respect to the screw." Appeal Br. 57 (Claims
App.).
In arguing that the "adapted to" language in claim 97 fails to
encompass the plate device disclosed in Harle, Appellants incorporate by
reference the arguments advanced regarding claim 85 and the "adapted to"
language in that claim. See Appeal Br. 28-29. Appellants also reiterate
their arguments that a skilled artisan would not have combined Harle and
Smaldone in the manner posited by the Examiner. Id. at 28.
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For the reasons discussed above, however, Appellants do not persuade
us that an ordinary artisan would not combine Harle and Smaldone in the
manner posited by the Examiner. For the reasons discussed above,
moreover, we are not persuaded that the disclosures in Appellants' written
description identify any specific structural attributes of the claimed rod, such
that the claimed rod is distinguishable from the plate device suggested by the
combination of Harle and Smaldone. Contrary to Appellants' contentions,
therefore, we conclude that the "adapted to" language in claim 97
encompasses the device suggested by the combination of Harle and
Smaldone.
We are also unpersuaded by Appellants' contention that, if Harle' s
rod were received by a locking mechanism as recited in claim 97, Harle' s
rod would then "no longer function for its intended purpose because it would
not be in contact with a bone surface as intended." Appeal Br. 31; see also
id. ("[T]he key features of the device of Harle include, delivering antibiotics
to a bone surface in contact with the plate of Harle, and help promote bone
growth.").
Claim 97 does not recite a rod in combination with a locking
mechanism, as Appellants appear to argue. Rather, claim 97 is limited to a
rod having a specific set of features, the rod also being "adapted to be
received by a locking mechanism comprising a screw in which elements of
the locking mechanism on opposing sides of the rod apply compressive force
to generally opposing sides of the rod, thereby fixing the rod in space with
respect to the screw." Appeal Br. 57 (Claims App.).
Similar to the situation discussed above in relation to claim 85,
Appellants do not persuade us that the written description relating to claim
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97 describes any specific structural attributes of the disclosed rod,
demonstrating that the "adapted to" language in claim 97 fails to encompass
the rod suggested by the combination of Harle and Smaldone. As discussed
below in relation to claim 107, we are not persuaded that the intended
purpose of Harle' s device would be lost if Harle' s device was not affixed
directly to bone. As to claim 97, however, because the claim recites only a
rod, as opposed to a combination of a rod and locking mechanism that
necessarily fixes the rod in a particular location, and because the
combination of Harle and Smaldone suggests a rod having all of structural
features of the rod, including the structural features encompassed by claim
97 's "adapted to" language, Appellants do not persuade us that the Examiner
erred in maintaining the obviousness rejection of claim 97 over Harle and
Smaldone.
Accordingly, for the reasons discussed, we affirm the Examiner's
rejection of claim 97 over Harle and Smaldone. Because they were not
argued separately, claims 99--106 fall with claim 97. 37 C.F.R.
§ 4I.37(c)(l)(iv).
OBVIOUSNESS-CLAIM 98
The Examiner's Prima Facie Case
In rejecting claim 98, which depends from claim 97 discussed above,
for obviousness over Harle, Smaldone, and Jacobson, the Examiner relied on
the teachings in Harle and Smaldone discussed above, and cited Jacobson as
evidence that it would have been obvious to combine a locking mechanism
as recited in claim 98, with the rod recited in claim 97. See Ans. 11.
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Analysis
Appellants do not direct specific argument to the Examiner's
combination of Harle, Smaldone, and Jacobson, but instead argue only that
"[c]laims 98-106 depend from independent claim 85 and are allowable for at
least the same reasons discussed with respect to claim 97." Appeal Br. 31.
As discussed above, we do not find Appellants' arguments regarding
claim 97 persuasive. Accordingly, because Appellants do not identify, nor
do we discern, error in the Examiner's conclusion of obviousness as to claim
98, we affirm the Examiner's rejection of claim 98 over Harle, Smaldone,
and Jacobson.
OBVIOUSNESS-CLAIMS 107-114
The Examiner's Prima Facie Case
In rejecting claims 107-114 for obviousness over Harle, Smaldone,
and Martinez, the Examiner cited the combination of Harle and Smaldone as
evidence that a rod composed of both metal and an elastomeric material
would have been obvious, relying essentially on the same rationale discussed
above as to claim 85. Ans. 12-13.
The Examiner cited Martinez as evidence that it was known in the art
to use a locking mechanism encompassed by the rejected claims for the
purpose of anchoring a stabilization device, such as that described by Harle,
to bone. Id. at 13-14. In particular, the Examiner reasoned that it would
have been obvious
to substitute the locking mechanism of Harle for a locking
mechanism having a body adapted to receive the rod and a
fixation mechanism adapted to engage bone, wherein the
locking mechanism is adapted to fix the rod in space with
respect to the fixation mechanism ... and to configure the rod
of the fixation assembly to receive the substitute locking
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mechanism, as taught by Martinez, since it is well-known in the
art to construct rods to receive one of locking mechanisms there
through, or locking mechanisms thereabout, for the purposes of
anchoring the rod to bone. [See also] Burton (US 4,743,260),
col. 6, lines 21-35.
Id. at 14.
Analysis
Claim 107 is representative of the claims subject to this ground of
rejection. 37 C.F.R. § 4I.37(c)(l)(iv). Having carefully considered all of
the arguments and supporting evidence advanced by Appellants and the
Examiner, Appellants do not persuade us that the preponderance of the
evidence fails to support the Examiner's conclusion of obviousness as to
claim 107 over Harle, Smaldone, and Martinez. To the contrary, we discern
no error in the Examiner's findings of fact as to the cited prior art, nor are
we persuaded of error in the Examiner's conclusion of obviousness based
thereon.
Claim 107 recites a fixation assembly composed of a rod having
similar features to the rod recited in claim 85, discussed above, composed of
a metal structure and elastomeric material that fills channels in the metal
structure. See Appeal Br. 59. Claim 107 requires the fixation assembly to
include "a locking mechanism having a body adapted to receive the rod and
a fixation mechanism adapted to engage bone, wherein the locking
mechanism is adapted to fix the rod in space with respect to the fixation
mechanism." Id.
Appellants reiterate their arguments that a skilled artisan would not
have combined Harle and Smaldone in the manner posited by the Examiner
to produce a rod composed of a combination of metal and an elastomeric
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material. Appeal Br. 31. For the reasons discussed above as to claim 85, we
do not find this argument persuasive.
Appellants contend also that a skilled artisan would not have been
motivated to combine Harle and Martinez in the manner posited by the
Examiner, and argue in particular that the Examiner's posited combination
would render each of Harle and Martinez unsuitable for its intended purpose.
See Appeal Br. 34--40. For the reasons discussed below, we do not find
Appellants' arguments persuasive.
As seen above, Harle' s bone fixation plate device includes bores,
through which screws pass, allowing the screws to secure the plate to the
bone, in tum allowing the plate to stabilize a fracture. See Harle 3: 12-15
("FIGS. 1 and 4 show a slightly domed bone plate which is given the general
designation 1 and in which spaces 2 for the screws used to fix the plate to
the bone or to the opposite plate are provided."). Harle' s device, thus,
differs from the assembly of Appellants' claim 107 in that Harle's bone
fixation device is secured to bone directly by screws that pass through the
device, rather than using a locking mechanism that receives the fixation
device in the manner cited in claim 107.
As the Examiner found, however (see Ans. 13), Martinez discloses
that, when securing a fixation device like Harle' s plate to bone, a locking
mechanism undisputedly encompassed by claim 107 was a useful alternative
to screws passing directly through the plate. See Martinez, Figs. 1 ( showing
fixation device 32 with screw holes 42 allowing direct securement to bone),
3 and 4 ( showing locking mechanism 66 with screws 62 for fixation to bone,
receiving fixation device 72).
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Given Martinez's teaching that, as an alternative to screws passing
directly through the plate as disclosed in Harle, a locking mechanism
encompassed by Appellants' claim 107 was a useful technique for securing a
fixation device to bone, we agree with the Examiner that an ordinary artisan
would have had a good reason to use a locking mechanism as taught in
Martinez, instead of Harle' s screws, to secure Harle' s fixation device to
bone. Appellants, therefore, do not persuade us that an ordinary artisan
lacked motivation to combine the teachings of Harle and Martinez, in the
manner posited by the Examiner. See KSR, 550 U.S. at 421 ("When there is
a design need or market pressure to solve a problem and there are a finite
number of identified, predictable solutions, a person of ordinary skill has
good reason to pursue the known options within his or her technical grasp.").
We are also unpersuaded that combining Harle' s fixation device with
Martinez's locking mechanisms would have rendered Harle's device
unsuitable for its intended purpose, because the fixation device would not
directly contact bone if the posited combination were made. See Appeal Br.
34--39.
We acknowledge, as Appellants contend, that Harle discloses that one
shortcoming identified in previous similar devices was that they did "not
permit an adequately high concentration of active ingredient at the point of
contact between metal and bone." Harle, 1 :44--46.
Harle, however, discloses that in addition to releasing antibiotic at the
site of the fracture, it is desirable to release antibiotic into the tissue operated
upon to implant the bone fixation device. See id. at 2:57---61 ("[B]y means
of the proposal according to the invention an exceptionally high release of
active ingredient in the immediate area of the fracture or of the operated
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area is ensured in every case.") (emphasis added). We note, moreover, that
Harle discloses coating all surfaces of the device, including non-bone-
contacting surfaces, with the antibiotic carrier material. See id. at 2:24--26,
Figs. 3, and 6 ).
Thus, although a configuration in which Harle' s device is secured
directly to bone might be a preferred embodiment, given the teachings in
Harle that the device was useful for releasing antibiotic into the tissue
operated upon to implant the device, and given the disclosure of applying the
antibiotic coating to non-bone-contacting portions of the device, Appellants
do not persuade us that combining Harle's device with Martinez's locking
mechanism would have rendered Harle' s device unsuitable for its intended
purpose.
We are also unpersuaded that combining Harle's fixation device with
Martinez's locking mechanism would have rendered Martinez's locking
mechanism unsuitable for its intended purpose. See Appeal Br. 39-40.
Contrary to Appellants' contention that Harle' s device is designed to
be rigid and not flexible (see id. at 39 ( citing Baker Deel. ,r 51) ), Harle
expressly discloses that its device may be configured "to permit bending"
(Harle, abstract), and should be "made of a material having appropriate
strength" (id. at 1 :5---6). Given these teachings, we are unpersuaded that an
ordinary artisan using Harle' s fixation device would have considered it
unobvious to determine a suitable degree of flexibility based on the intended
application.
Appellants, moreover, do not identify any specific evidence
supporting the assertion that Harle' s device would fail or cause spinal
damage if used in combination with Martinez's locking mechanism. See
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Appeal Br. 40 ( citing Baker Deel. ,r 51 ). As noted above, Harle broadly
discloses that its fracture fixation device should be constructed "of a material
having appropriate strength." Harle 1:5---6.
Moreover, as discussed above, the An and Aebi references cited by
Appellants support a finding that both plates and rods may be used in spinal
fixation. See An 78 ("Recently, various fixation devices using pedicle
screws and plates (or rods) have been introduced. Regardless of the type of
longitudinal linkage connecting the pedicle screws, intrapedicular fixation
was known to provide sufficient rigidity.") ( emphasis added); see also Aebi,
10 ("Following decompression and anterior column reconstruction, the
system can be converted from an unconstrained into a constrained system
during surgery, utilizing either a rigid-plate screw system (ATLP) or a
double rod and screw system (USS Ventrofix).") (emphasis added).
As also discussed above, the Thramann reference cited by the
Examiner similarly discloses that both plates and rods may be used in spinal
fixation. Thramann, Abstract ("A dynamic spinal stabilization apparatus
comprises a stabilization device such as a rod or a plate.") ( emphasis added).
Thus, that Harle characterizes its fixation device as a plate does not persuade
us that Appellants' claim 107, including the claim's "adapted to" language,
fails to encompass Harle' s device, or that using Harle' s device in
combination with Martinez's locking mechanism would render Martinez
unsuitable for its intended purpose.
In sum, for the reasons discussed, Appellants do not persuade that the
preponderance of the evidence fails to support the Examiner's conclusion of
obviousness as to Appellants' claim 107. We, therefore, affirm the
Examiner's rejection of claim 107 over Harle, Smaldone, and Martinez.
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Because they were not argued separately, claims 108-114 fall with claim
107. 37 C.F.R. § 4I.37(c)(l)(iv).
OBVIOUSNESS-CLAIMS 115-121
The Examiner's Prima Facie Case
In rejecting claims 115-121 for obviousness over Harle, Smaldone,
and Martinez, the Examiner cited the combination of Harle and Smaldone as
evidence that a rod composed of both metal and an elastomeric material
would have been obvious, relying essentially on the same rationale discussed
above as to claims 85, 97, and 107. Ans. 16-17.
For reasons similar to those in the rejection of claim 107 discussed
above, the Examiner cited Martinez as evidence that it was known in the art
to use a locking mechanism encompassed by claims 115-121 for the purpose
of anchoring a stabilization device, such as that described by Harle, to bone.
Id. at 17-18.
Analysis
Claim 115, the sole independent claim subject to this ground of
rejection, recites a fixation assembly similar to that recited in claim 107
discussed above, the assembly being composed of a rod and locking
mechanism. Appeal Br. 61, (Claims App.).
In asserting error in the Examiner's rejection of claim 115, Appellants
reiterate the same arguments advanced against the Examiner's rejection of
claim 107, discussed above. See id. at 41-52. For the reasons discussed
above as to claim 107, we do not find Appellants' arguments persuasive as
to claim 115 .
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Accordingly, we affirm the Examiner's rejection of claim 115 over
Harle, Smaldone, and Martinez. Because they were not argued separately,
claims 116-121 fall with claim 107. 37 C.F.R. § 4I.37(c)(l)(iv).
DECISION
For the reasons discussed, we affirm each of the Examiner's
obviousness rejections.
For the reasons discussed, we reverse the Examiner's indefiniteness
rejection.
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
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