Ex Parte Tormala et al

Board of Patent Appeals and Interferences

May 27, 2008

08921533 (B.P.A.I. May. 27, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte PERTTI TÖRMÄLÄ, MINNA KELLOMAKI, WILLIAM
BONFIELD, and KATHLEEN E. TANNER
__________

Appeal 2008-2657
Application 08/921,533
Technology Center 1600
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Decided: May, 27, 2008
__________

Before DEMETRA J. MILLS, RICHARD M. LEBOVITZ, and JEFFREY
N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
biodegradable and bioactive composite material which the Examiner has
rejected under the judicially created doctrine of obviousness type double
patenting. We have jurisdiction under 35 U.S.C. § 6(b). We affirm in part
and reverse in part.

Appeal 2008-2657
Application 08/921,533

Background
“In surgery, either biostable or biodegradable devices are used for the
fixation of bone fractures to immobilize the bone fragments and accelerate
patient mobilization” (Spec. 1). The Specification notes that “[m]ost
biostable devices are typically made of metallic alloys” (Spec. 1).
According to the Specification, “[b]ioresorbable polymeric fracture fixation
devices have been studied as replacements for metallic implants” (Spec. 2).
“Törmälä et al. have developed self-reinforced bioresorbable polymeric
composites to improve the strength of bioresorbable polymer devices. These
show good mechanical properties: e.g. bending strengths of 360±70 MPa
and bending moduli of 12±2 GPa, respectively, have been reported” (Spec.
2).
Statement of the Case
The Claims
Claims 1-6 and 9-22 are on appeal. We will focus on claim 1, which
is representative and reads as follows:
1. A biodegradable and bioactive composite material for
surgical osteosynthesis applications comprising: i) at least
one resorbable polymeric matrix component, ii) at least one
resorbable polymeric reinforcing component and iii) at least
one bioceramic or bioglass reinforcing component mixed
with said matrix component, wherein the bioceramic or
bioglass reinforcing component has a particle size of is [sic]
between 60 µm and 150 µm.

The prior art
The Examiner relies on the following prior art references to show
unpatentability:
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Törmälä US 4,743,257 May 10, 1988
Bajpai US 4,778,471 Oct. 18, 1988
Törmälä US 6,406,498 B1 Jun. 18, 2002

The issue
The rejection as presented by the Examiner is as follows:
Claims 1-6 and 9-22 stand rejected under the judicially created
doctrine of obviousness-type double patenting as obvious over claims 1-10
of Törmälä ‘498 in view of Törmälä ‘257 and Bajpai (Ans. 3).

Obviousness type double patenting rejection
The Examiner argues that
[a]lthough the conflicting claims are not identical, they are
not patentably distinct from each other because '498 teach
bioactive, bioabsorbable surgical composite material
comprising a bioabsorbable polymer matrix that is oriented
and bioactive glass or ceramic particles dispersed in the
matrix that is self-reinforced, wherein said particles extend
at least into said pores.

(Ans. 3.) The Examiner also notes that “‘498 claims particle sizes but fails
to claim the specific particle size of 60 to 150 microns” (Ans. 3). The
Examiner relies upon Törmälä ‘257 to “teach mixing together a melt of the
absorbable polymer or copolymer and subjecting to heat and pressure
(examples and claim 12)” (Ans. 4). The Examiner relies upon Bajpai to
“teach particulate ceramic materials that have particle size of about 1 to 400
microns. ‘471 teach that for a bone implant device, a particle size of 40 to
200 microns can be used” (Ans. 4).
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Appellants argue that “there is no motivation to combine the '471
patent with the claims of the ‘498 patent” (App. Br. 5). Appellants contend
that the Törmälä ‘498 patent claims “are clearly directed to a surgical
composite material that comprises a polymer matrix that has bioactive glass
or ceramic dispersed therein. The ‘471 patent, on the other hand, is directed
to a ceramic used as a drug delivery system, cement or grout or a preformed
implant or ceramic block” (App. Br. 5). Appellants conclude that “[t]here is
no suggestion that the powdered ceramic described in the '471 patent should
be dispersed in any way in other material to form a composite material”
(App. Br. 5).
Appellants also argue that “the claimed particle size of 60 µm to 150
µm of the bioglass or bioceramic reinforcing component is contrary to
conventional practice and renders unexpected benefits, such as greater
biocompatibility and less irritation to tissue compared to particle sizes taught
in the art” (App. Br. 6).
In view of these conflicting positions, we frame the obviousness-type
double patenting issues before us as follows:
(1) Would it have been obvious to a person of ordinary skill to select
particles from 60 µm to 150 µm from Bajpai as reinforcing the polymer
matrix of claims 1-10 of Törmälä ‘498?
(2) Does the evidence support a conclusion of a secondary
consideration of unexpected results for the specific particle sizes claimed?
Findings of Fact
1. Törmälä ‘498, claim 1 teaches
[a] bioactive, bioabsorbable surgical composite material
comprising: a bioabsorbable polymer matrix which is
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oriented, said matrix having an outer surface and containing
a plurality of pores, wherein at least some of said pores open
at the surface of said matrix; and bioabsorbable or bioactive
particles dispersed into the polymer matrix, said particles
being comprised of glass or ceramic, wherein said particles
extend at least partially into said pores.

(Törmälä ‘498 16:45-54, claim 1).
2. Törmälä ‘498, claim 5 teaches “[a] composite material
according to claim 1, wherein said matrix is self-reinforced” (Törmälä ‘498
16:64-65).
3. Törmälä ‘498 discloses the use of particles of 50-125 µm in the
manufacturing method in the Specification (Törmälä ‘498, 8:43).
4. Bajpai teaches the use of zinc ceramics as implants with the
“implant being essentially non-toxic and bioabsorbable” (Bajpai 2:30-31; 1:
5-7).
5. Bajpai states that the ceramic can be in powder form where the
“particle size of the bioceramic varies with the end use” (Bajpai 3:10-11).
Bajpai teaches that where the ceramic is used for cement or grout, “the
ceramic has a particle size of about 1 to 400 microns” (Bajpai 3:13-14).
However, Bajpai teaches that where the ceramic is used “[f]or a bone
implant device, the ceramic has a particle size of about 40 to 200 microns”
(Bajpai 3:14-16).
6. Törmälä ‘257 teaches an osteosynthesis material that “is self-
reinforced, i.e. it is formed of an absorbable polymer or copolymer matrix
which is reinforced with absorbable reinforcement which have the same
chemical element percentage composition as does the matrix” (Törmälä ‘257
3:8-12).
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7. Törmälä ‘257 teaches “methods which can be applied in
manufacturing of self-reinforced absorbable osteosynthesis materials”
(Törmälä ‘257 4:1-3).
8. Törmälä ‘257 teaches manufacturing reinforced osteosynthesis
materials by
(a) Selecting an “absorbable polymer” (Törmälä ‘257 4:19),
(d) Selecting a second polymer of “fibers, threads or corresponding
reinforcement elements of the same material” (Törmälä ‘257 4:19-20),
(e), (f) “forming the mixture of the polymer melt and reinforcement
elements into the desired form” (Törmälä ‘257 4:20-22),
(g) “cooling the formed polymers composite so rapidly that the
reinforcement elements do not significantly lose their oriented internal
structure” (Törmälä ‘257 4:22-25).
9. Törmälä ‘257 teaches fibers for self reinforcement with a
variety of diameters (Törmälä ‘257 6:30-60). Specifically, Törmälä ‘257
teaches “[p]oly-β-hydroxybutyric acid (Mw=80,000) fibers (diameter 15
µm)” (Törmälä ‘257 6:54-55). Törmälä ‘257 also discloses fibers with
diameters of 6 µm (Törmälä ‘257 7:23) and 12 µm (Törmälä ‘257 6:42-43).
Discussion of the Obviousness type double patenting rejection
Claim 1
We conclude that the Examiner has set forth a prima facie case that
claim 1 is obvious over claims 1-10 of Törmälä ‘498, Törmälä ‘257 and
Bajpai. Claim 1 of Törmälä ‘498 teaches bioabsorbable composite materials
which comprise a “bioabsorbable polymer matrix” and a bioglass or
bioceramic reinforcing component (FF 1) as in instant claim 1. Törmälä
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‘257 teaches the use of a polymeric self reinforcement material which is
absorbable (FF 6). Bajpai teaches the use of bioceramic particles in implants
with a particle size between 40 and 200 microns (FF 4-5). Based on these
teachings, we agree with the Examiner that
it would have been obvious for one of an ordinary skill in
the art at the time of the instant invention to employ bioglass
or ceramic particles, in an appropriate particle size range in
the surgical composite material of '498 depending on the use
of ceramic particles as a cement or for drug delivery,
because '471 suggests specific particle sizes for either
purposes (cement or drug delivery) and suggests that
increase in particle size is associated with a decrease in
mechanical strength and an increase in porosity.

(Ans. 4-5.)
We are not persuaded by Appellants’ argument that “there is no
motivation to combine the ‘471 patent with the claims of the ‘498 patent”
(App. Br. 5). Both Törmälä ‘498 and Bajpai are concerned with
bioabsorbable implants (FF 1, 5) and Bajpai teaches the use of ceramic
particles in the size range of 40 to 200 microns when making bone implants
(FF 4). Bajpai provides specific motivation to use resorbable zinc ceramic
particles of the claimed size in implants, teaching that “an object of the
present invention is to replace the aluminum oxide in aluminum based
ceramics with zinc oxide to provide a ceramic having the properties of an
aluminum based ceramic and which is resorbable but without the potential
toxic side effects of aluminum” (Bajpai 2:3-8).
We are also not persuaded by Appellants’ argument that “[t]here is no
suggestion that the powdered ceramic described in the ‘471 patent should be
dispersed in any way in other material to form a composite material” (App.
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Br. 5). Claim 1 of Törmälä ‘498 expressly teaches the use of ceramic
materials “dispersed into the polymer matrix” of the composite material (FF
1), and Bajpai teaches that the zinc ceramic particles are useful in bone
implants (FF 4). In KSR, the Supreme Court stated that “[w]hen a work is
available in one field of endeavor, design incentives and other market forces
can prompt variations of it, either in the same field or a different one. If a
person of ordinary skill can implement a predictable variation, §103 likely
bars its patentability.” KSR Int’l v. Teleflex Inc., 127 S. Ct. 1727, 1740
(2007). In the instant case, selection of Bajpai’s ceramic particles used to
form bone implants for use in the composite surgical implant material of
claim 1 of Törmälä ‘498 is a predictable variation, particularly since claim 1
of Törmälä ‘498 expressly teaches the use of ceramic particles (FF 1) and
Bajpai teaches a ceramic particle which is useful in implantable materials.
Appellants argue that there are unexpected results regarding the
particle size. Appellants contend that coarser particles, of 80 +/- 20 microns
show greater biocompatibility than finer particles of 7.43 microns (see App.
Br. 6). Appellants present evidence to support this contention in Example
11 of the Specification (Spec. 13:8-23).
We reject Appellants argument because evidence of unexpected
results must be compared to the closest prior art. See In re De Blauwe, 736
F.2d 699, 705 (Fed. Cir. 1984)(“an applicant relying on comparative tests to
rebut a prima facie case of obviousness must compare his claimed invention
to the closest prior art.”) In this case, the closest prior art ranges for the
particle sizes would have been the 40 to 200 micron particle size range
disclosed by Bajpai (FF 4). In either case, the lower range point selected by
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Appellants of 7.43 microns, did not fall within the ranges disclosed by the
prior art as useful in bone implants (see FF 3-4). Therefore, “appellants'
assertions of unexpected results constitute mere argument and conclusory
statements in the specification which cannot establish patentability.” In re
De Blauwe, 736 F.2d at 705.
We therefore affirm the obviousness type double patenting rejection
of claim 1 as obvious over claims 1-10 of Törmälä ‘498, Törmälä ‘257 and
Bajpai. Claims 5, 6 and 11-13 fall with claim 1 as they were not separately
argued.
Claims 2, 17, 18, 19, and 20
Appellants’ argue that the “‘498 patent recites no method of
manufacturing a biodegradable composite. The ‘257 patent makes no
mention of a bioceramic or bioglass reinforcing component. Therefore, steps
(c) and (f) of claim 2 are not disclosed by the combination of the ‘257 patent
and the '498 claims” (App. Br. 7).
We find that Törmälä ‘257 teaches the entire manufacturing method
(FF 8) except for the incorporation of ceramic particles into the first polymer
as required by elements b) and c) of the claims. However, claim 1 of
Törmälä ‘498 expressly requires that the composite material incorporate
glass or ceramic particles (FF 1) and Bajpai teaches ceramic particles for use
in bone implants (FF 4). We conclude that the express teaching by claim 1
of Törmälä ‘498 to incorporate glass or ceramic particles into the matrix
would have suggested performance of the selecting step (b) and mixing step
(c) in order to disperse the particles as required by claim 1 of Törmälä ‘498.
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Such a combination is merely a “predictable use of prior art elements
according to their established functions.” KSR, 1727 S. Ct. at 1740.
We therefore affirm the obviousness type double patenting rejection
of claim 2 as obvious over claims 1-10 of Törmälä ‘498, Törmälä ‘257 and
Bajpai. Claims 17-20 fall with claim 2 as they were not separately argued.
Claims 3, 4 and 16
Appellants argue regarding claim 3 that the prior does not teach a
“reinforcing component has a fiber diameter greater than the diameter or
particle size of the bioceramic or bioglass reinforcing component” (App. Br.
8). The Examiner responds that the Törmälä ‘257 teaches fibers with
diameters of “4.5 mm, 4.9 mm etc (see examples of ‘257), which are much
greater than the particle sizes described by ‘471” (Ans. 8).
The fiber diameters in Törmälä ‘257 of 4.5 mm referenced by the
Examiner refer to the completed mixture and not to the individual fibers
within the mixture (see Törmälä ‘257 5:30-35, “The melt-fiber mixture was
formed rapidly to cylindrical samples (diameter 4.5 mm)”). When Törmälä
‘257 does discuss fibers in the mixture, the diameters are much smaller, with
a diameter of 12 µm for the poly-L-lactide fibers and 15 µm for the poly-B-
hydroxybutyric acid fibers (see Törmälä ‘257 6:42-43, 6:54-55). These fiber
diameters are smaller than the particle diameters suggested by Törmälä ‘257
for use in implants (FF 4).
We agree with Appellants that since Törmälä ‘257 does not teach
fibers with larger diameters than the reinforcing particles it would not have
been obvious to have a fiber diameter greater than the diameter of the
particle reinforcing component as required by claims 3, 4, and 16.
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We reverse the obviousness type double patenting rejection of claims
3, 4, and 16 as obvious over claims 1-10 of Törmälä ‘498 in view of
Törmälä ‘257 and Bajpai.
Claims 9 and 10
Appellants argue regarding claims 9 and 10 that the prior art does not
teach that an “amount of the bioceramic or bioglass reinforcing component
is 0.15 to 0.9 and 0.2 to 0.6 volume fraction” (App. Br. 9). Appellants argue
that the “’498 patent claims simply provide no guidance to any particular
amount range for the claimed bioabsorbable or bioactive particle. Moreover,
the Examiner has pointed to no teaching that indicates that the amount of
bioglass or bioceramic reinforcing component is a result-effective variable”
(App. Br. 9). The Examiner responds to this argument that “optimizing the
volume of ceramic particles in the implant or composite material of ‘498
would have been within the scope of a skilled artisan” (Ans. 8).
In KSR, the Supreme Court noted that “the [obviousness] analysis
need not seek out precise teachings directed to the subject matter of the
challenged claim, for a court can take account of the inferences and creative
steps that a person of ordinary skill in the art would employ”. KSR Int’l v.
Teleflex Inc., 127 S. Ct. 1727, 1741, (2007). Here, when Törmälä ‘257
teaches to incorporate reinforcement units into a surgical osteosynthesis
material such as that taught in claims 1-10 of Törmälä ‘498 (FF 1-5), the
person of ordinary skill would have recognized that the amounts of material
being incorporated may be optimized to result in optimal strength of
reinforcement. See In re Boesch, 617 F.2d 272, 276 (CCPA 1980).
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(“[D]iscovery of an optimum value of a result effective variable in a known
process is ordinarily within the skill of the art.”)
We therefore affirm the obviousness type double patenting rejection
of claims 9 and 10 as obvious over claims 1-10 of Törmälä ‘498, Törmälä
‘257 and Bajpai.
Claim 14
Appellants argue regarding claim 14 that the prior art does not
“describe any specific types of bioactive glass or ceramic particles, let alone
the specific types of particles recited by claim 14” (App. Br. 10). The
Examiner responds that “the ceramic particles of ‘257 do[] read on the
instant bioceramic materials and further, ‘257 does recognize hydroxyapatite
as the conventional ceramic materials for drug delivery systems” (Ans. 8).
We note that the Examiner also identified support for the use of
hydroxyapatite in Bajpai (see Ans. 4), where Bajpai recognized that
hydroxyapatite is an equivalent material for use in the same applications as
the ceramics (see Bajpai, col. 1, ll. 63-67). Such a substitution of a known
material is merely a “predictable use of prior art elements according to their
established functions.” KSR Int’l v. Teleflex Inc., 127 S. Ct. 1727 (2007).
We affirm the obviousness type double patenting rejection of claim 14
as obvious over claims 1-10 of Törmälä ‘498, Törmälä ‘257 and Bajpai.
Claim 15
Appellants argue that the prior art does not teach that “the composite
material exhibits ductile behavior under load” (App. Br. 10). Appellants
Specification does not define ductile, but does state that reinforcement
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“changes the behavior of the material from brittle to ductile and thus makes
the reinforced device more reliable under load” (Spec. 8:1-2).
We think that the teaching of Appellants own Specification cited
above supports the conclusion that reinforcement of a material will make
that material more ductile. Since both claims 1-10 of Törmälä ‘498 and the
disclosure of Törmälä ‘257 expressly discuss reinforcement of the
osteosynthesis materials with fibers and particles, it is necessarily the case
that the composite materials of the prior art will show some level of ductility
consistent with the admission of Appellants’ Specification.
We therefore affirm the obviousness type double patenting rejection
of claim 15 as obvious over claims 1-10 of Törmälä ‘498, Törmälä ‘257 and
Bajpai.
Claims 21 and 22
Appellants argue that the prior art does not teach “any particular fiber
diameter, let alone the specific fiber diameter recited by claims 21 and 22”
(App. Br. 11). In fact, Törmälä ‘257 teaches the use of fibers with diameters
of 6 µm, 12 µm, and 15 µm (FF 9). These diameters fall within the range
claimed by claim 21. While the fiber diameters in Törmälä ‘257 do not
teach the minimum 20 µm required by claim 22, we think that in view of the
closeness of the ranges, and the expectation that even larger diameters would
work, an ordinary practitioner would have had the creativity to routinely
optimize the fiber diameters. See KSR supra; Titanium Metals Corp. of
America v. Banner, 778 F.2d 775, 783 (Fed. Cir. 1985).
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We therefore affirm the obviousness type double patenting rejection
of claims 21 and 22 as obvious over claims 1-10 of Törmälä ‘498, Törmälä
‘257 and Bajpai.
CONCLUSION
In summary, we affirm the rejection of claims 1, 2, 9, 10, 14, 15, 21
and 22 under the judicially created doctrine of obviousness type double
patenting. Pursuant to 37 C.F.R. § 41.37(c)(1)(vii)(2006), we also affirm the
rejections of claims 5, 6, 11-13, and 17-20 as these claims were not argued
separately. We reverse the rejections of claims 3, 4, and 16 under the
judicially created doctrine of obviousness type double patenting.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006).

AFFIRMED IN PART

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