Ex Parte CIMA et al

Board of Patent Appeals and Interferences

Mar 21, 2002

08463203 (B.P.A.I. Mar. 21, 2002)

The opinion in support of the decision being entered today was not
written for publication and is not binding precedent of the Board.
Paper No. 20
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte LINDA G. CIMA and MICHAEL J. CIMA
____________
Appeal No. 1998-2813
Application No. 08/463,203
____________
HEARD: September 12, 2000
____________
Before CALVERT, FRANKFORT, and JENNIFER D. BAHR, Administrative
Patent Judges.
FRANKFORT, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal from the examiner's final
rejection of claims 19 through 25 and 29 through 36. Claim 37
stands allowed. Claims 26 through 28, the only other claims
remaining in the application, have been indicated by the examiner
as containing allowable subject matter, but stand objected to
until they are rewritten in independent form including all the
limitations of the base claim and any intervening claims. Claims
1 through 18 have been canceled.
Appeal No. 1998-2813
Application No. 08/463,203
2
Appellants' invention relates to a medical device for tissue
regeneration formed using a solid free-form fabrication method.
Examples of such methods are set forth on page 4 of the
specification, where it is additionally noted that three
dimensional printing (hereinafter 3D-printing) is the preferred
method for creating appellants' medical devices. Appellants'
devices are constructed to include a matrix of successive layers
of biocompatible polymeric material having interconnected pores
extending throughout the matrix suitable for seeding or ingrowth
of cells. Claims 19 and 21 are representative of the subject
matter on appeal and a copy of those claims, as they appear in
Appendix I of appellants' brief, is attached to this decision.
The single prior art reference relied upon by the examiner
in rejecting the appealed claims is:
Fink et al. (Fink) 5,370,692 Dec. 6, 1994
(filed Aug. 14, 1992)
Claims 19, 31, 32/19 and 36/19 stand rejected under
35 U.S.C. § 102(e) as being clearly anticipated by Fink.
Claims 20, 22/20, 29, 30 and 33 through 35 stand rejected
under 35 U.S.C. § 102(e) as being anticipated by Fink or, in the
Appeal No. 1998-2813
Application No. 08/463,203
3
alternative, under 35 U.S.C. § 103 as being unpatentable over
Fink.
Claims 21, 22/21, 23 through 25, 32/21 and 36/21 stand
rejected under 35 U.S.C. § 103 as being unpatentable over Fink.
Rather than attempt to reiterate the examiner's full
commentary with regard to the above-noted rejections and the
conflicting viewpoints advanced by the examiner and appellants
regarding the rejections, we make reference to the examiner's
answer (Paper No. 14, mailed January 29, 1998) for the reasoning
in support of the rejections, and to appellants' brief (Paper
No. 11, filed January 5, 1998) and reply brief (Paper No. 15,
filed March 27, 1998) for the arguments thereagainst.
OPINION
In reaching our decision in this appeal, we have given
careful consideration to appellants' specification and claims,
to the applied prior art Fink reference, and to the respective
positions articulated by appellants and the examiner. As a
consequence of our review, we have made the determinations which
follow.
Appeal No. 1998-2813
Application No. 08/463,203
4
Regarding the examiner's rejection of claims 19, 31, 32/19
and 36/19 under 35 U.S.C. § 102(e) as being anticipated by Fink,
our reading of the Fink patent indicates that it is directed to
the fabrication of prosthetic implants to replace bone (i.e.,
medical devices) that are formed using various free-form
manufacturing techniques (col. 4, line 3, et. seq.) including
selective laser sintering and 3D-printing. These devices are
indicated (col. 5, lines 23-34) as being constructed to maximize
"the rate and quality of cell-mediated hard tissue healing" and
to "optimize the rate of healing by incorporating the patient's
own bone-producing cells into the implant" (emphasis added).
Fink notes (col. 3, line 7, et. seq.) that the most important
physical properties of the implant are the volume and size of the
pores within the implant, since such factors strongly influence
not only the strength of the implant but also the rate of
resorption and cellular colonization. In this regard, it is
indicated that pores of "at least" 200-300 micrometers in
diameter are necessary in osteoconductive materials to permit
ingrowth of vasculature and osteogenic cells. An example of an
implant material (col. 3, lines 23-25) is said to be composed of
a network of interconnecting pores in the range of approximately
200 µm diameter. While Fink generally discloses the use of
resorbable, biocompatible ceramic materials to construct the
Appeal No. 1998-2813
Application No. 08/463,203
5
devices therein, this patent notes (col. 7, lines 31-38) that "a
polymeric FFM [free-form manufacturing] reproduction may also be
done using photoactive polymer techniques." Note also, column 7,
line 44, et. seq., wherein a composite polymeric/ceramic process
is described. When Fink uses the language "fluid materials" in
describing the free-form manufacturing of an implant it is made
clear in column 7, lines 37-38, that such language encompasses
either liquids or masses of particles being used in the
fabrication process.
In contrast to appellants' arguments in the brief and reply
brief, we are of the opinion that Fink teaches a medical implant
as set forth in claim 19 on appeal which is made using solid
free-form fabrication methods and comprises a matrix of
successive layers of biocompatible polymeric material having
interconnected pores extending throughout the matrix suitable for
seeding or ingrowth of cells. Again, we note that Fink discloses
the use of polymeric materials in column 7, lines 31-35 and in
column 7, line 46, et. seq., for making the devices therein and
discloses the importance of pore structure (e.g., volume and
size) within the matrix so as to allow the seeding of cells
(col. 5, lines 32-34) and the ingrowth of vasculature and
osteogenic cells (col. 3, lines 7-15). See also column 7, lines
Appeal No. 1998-2813
Application No. 08/463,203
6
20-30, wherein it is noted that a defined porosity can be
introduced into the implant by various methods and that such
processes "offer a range of porosities available to tailor FFM
devices to specific applications." While Fink does indicate that
the methods therein can be used to provide an implant that
replicates bone, we observe that this patent also teaches
secondary manipulation of the "design file" to compensate for the
anticipated healing process, prior to forming the "sliced file"
that is actually used to fabricate the implant (col. 5, lines
44+). Moreover, Fine also discloses (col. 6, line 20, et. seq.)
that while the implant may be matched to the precise anatomical
dimensions of the original tissue, it may also be modified to
compensate for the anticipated healing responses or to provide
for surgical-assist structures. Thus, appellants' arguments that
Fink deals strictly with replication of bone and that the
porosity of bone is smaller than that necessary to allow seeding
of cells mischaracterize the disclosure of Fink and are therefore
of no moment. In this regard, we again note that Fink discloses
that pore sizes of "at least" 200-300 micrometers in diameter are
necessary in osteoconductive materials to permit ingrowth of
vasculature and osteogenic cells, and that a known matrix
material is composed of a network of interconnecting pores in the
range of approximately 200 µm diameter.
Appeal No. 1998-2813
Application No. 08/463,203
7
Based on the foregoing, we will sustain the examiner's
rejection of independent claim 19 on appeal under 35 U.S.C.
§ 102(e). We will likewise sustain the examiner's rejection of
claims 31, 32/19 and 36/19 on this basis, since we find no
arguments in appellants' brief or reply brief that specifically
address these claims and which particularly point out any error
in the examiner's position. As indicated in 37 CFR
§ 1.192(c)(7), merely pointing out differences in what the claims
cover is not an argument as to why the claims are separately
patentable.
Next for our consideration is the examiner's rejection of
claims 20, 22/20, 29, 30 and 33 through 35 under 35 U.S.C.
§ 102(e) as being anticipated by Fink or, in the alternative,
under 35 U.S.C. § 103 as being unpatentable over Fink. Claim 20,
which depends from claim 19, is directed to the specific 3D-
printing process used by appellants and sets forth the steps of
a) spreading a first dispersion of a biocompatible polymer powder
onto a bed, b) printing a layer comprising a second dispersion of
biocompatible polymer in a solvent which binds the first
biocompatible polymer powder to the second biocompatible polymer
at locations where it is desired to have walls, and c) repeating
Appeal No. 1998-2813
Application No. 08/463,203
1 It appears to us that since the matrix as defined in
independent claim 19 and also in independent claim 21 is formed
of "successive layers" of biocompatible polymeric/composite
material, that step c) in each of these claims should read ---
repeating steps a and b until the desired matrix is formed ---,
thereby providing the "successive layers" that each of these
claims requires.
8
step b until the desired matrix is formed. 1 It is the examiner's
position (answer, pages 5-6) that
Fink et al is considered to anticipate
the claimed product even though the
particular method steps are not recited
therein because it is believed that the same
product would result from the method
limitations as set forth in the claim; see
MPEP § 2173.05(p). Alternatively, it is not
explicitly clear that the same material as
disclosed by Fink et al would be the result
of the claimed method steps. However, the
Examiner posits that the claimed product is
at least obvious in view of Fink et al alone
because the Fink et al method would result in
a product which is at least substantially
identical to the claimed product.
The problem we see with the examiner's position here is that
he has made no factual findings to support the bare conclusion
stated, i.e., that the Fink method would result in a product
which is at least substantially identical to the claimed product.
Like appellants, we fail to find in Fink any teaching or
suggestion of a medical device as claimed wherein the matrix
layers of the device are formed from a biocompatible polymeric
powder bonded using a polymer/solvent printed at locations where
Appeal No. 1998-2813
Application No. 08/463,203
9
it is desired to form walls in the matrix. The closest
embodiment found in Fink seems to be that set forth in column 7,
lines 48-53, wherein ceramic particles are suspended in a liquid
monomer which is subjected to laser photo polymerization whereby
the particles are then trapped in the polymer after
polymerization. However, we have no reason to conclude that the
matrix of the device formed by appellants' method in claim 20 and
Appeal No. 1998-2813
Application No. 08/463,203
10
that formed in the process noted above in Fink are "substantially
identical" one to the other, and the examiner has provided no
reasons which mandate such a conclusion. In our view, the
polymer/solvent bonding of polymeric powders in appellants'
method and the laser photo polymerization suggested in Fink will
result in devices with matrix structures that are clearly
different from one another. Thus, we will not sustain the
examiner's rejection of claim 20 under 35 U.S.C. § 102(e)/§ 103
based on Fink. It follows that the examiner's rejection of claim
22/20 will also not be sustained.
Claims 29 and 30 depend from claim 19, while claims 33
through 35 are multiply dependent, through claim 32, from either
claim 19 or claim 21. As the examiner's rejection applies to
those claims which depend from claim 19, we note that we find no
arguments in appellants' brief or reply brief that specifically
address these claims and which particularly point out any error
in the examiner's position. Finding no specific arguments from
appellants, we will therefore sustain the examiner's rejection of
claims 29 and 30, 33/32/19, 34/32/19 and 35/34/32/19. Our
disposition of claims 33 through 35 as they depend from
independent claim 21 will be clear from our discussions infra.
Appeal No. 1998-2813
Application No. 08/463,203
11

Appeal No. 1998-2813
Application No. 08/463,203
12
Claims 21, 22/21, 23 through 25, 32/21 and 36/21 stand
rejected under 35 U.S.C. § 103 as being unpatentable over Fink.
Independent claim 21 is similar to claim 20 discussed above and
for the same reasons as we noted with regard to claim 20 it is
our opinion that the examiner has failed to establish a prima
facie case of obviousness with regard to appellants' claim 21.
We have no reason to conclude that the matrix of the device
formed by appellants' method in claim 21 and that formed in the
process noted above in Fink are "substantially identical" one to
the other, and the examiner has provided no reasons which support
or mandate such a conclusion. In our view, the polymer/solvent
bonding of polymeric powders in appellants' method (claim 21) and
the laser photo polymerization suggested in Fink will result in
devices with matrix structures that are clearly different from
one another. Thus, the examiner's rejection of claim 21 and all
of the claims which depend therefrom will not be sustained.
This leaves the examiner's § 103 rejection of claims 23
through 25 as they depend from claim 19 for our consideration.
In this instance, appellants have argued (brief, page 13) that
Fink does not teach or suggest devices as set forth in these
claims including a matrix that has walls that are 100 microns
thick (claim 23), or devices including a matrix formed of the
Appeal No. 1998-2813
Application No. 08/463,203
2 With respect to claim 23, while we see clear support in
claim 21 for "the walls" of claim 23, we find no proper
antecedent basis for "the walls" in claim 19, from which claim 23
also depends. During any further prosecution of this application
before the examiner, this issue should be addressed.
13
polymers listed in claim 24, or wherein the polymer includes a
biodegradable latex as required in claim 25. Since we agree with
appellants, we will not sustain the examiner's rejection of
claims 23/19, 24/19 or 25/19.2
In view of the foregoing, the examiner's decision rejecting
claims 19, 31, 32/19 and 36/19 under 35 U.S.C. § 102(e) as being
clearly anticipated by Fink is affirmed. As regards the
examiner's rejection of claims 20, 22/20, 29, 30 and 33 through
35 under 35 U.S.C. § 102(e) as being anticipated by Fink or, in
the alternative, under 35 U.S.C. § 103 as being unpatentable over
Fink, we note that the examiner's decision has been sustained
with respect to claims 29 and 30, 33/32/19, 34/32/19 and
35/34/32/19, but reversed as to claims 20, 22/20, 33/32/21,
34/32/21 and 35/34/32/21. The examiner's decision rejecting
claims 21, 22/21, 23 through 25, 32/21 and 36/21 under 35 U.S.C.
§ 103 as being unpatentable over Fink has been reversed with
regard to claim 21 and all claims which depend from claim 21.
Appeal No. 1998-2813
Application No. 08/463,203
14
However, this rejection has been sustained with respect to claims
23/19, 24/19 and 25/19. Thus, the examiner's decision rejecting
the claims before us on appeal is affirmed-in-part.
No period for taking any subsequent action in connection
with this appeal may be extended under 37 CFR § 1.136(a).
AFFIRMED-IN-PART
IAN A. CALVERT )
Administrative Patent Judge )
)
)
)
) BOARD OF PATENT
CHARLES E. FRANKFORT ) APPEALS
Administrative Patent Judge ) AND
) INTERFERENCES
)
)
)
JENNIFER D. BAHR )
Administrative Patent Judge )
CEF/sld
Appeal No. 1998-2813
Application No. 08/463,203
15
PATREA L. PABST
ARNALL, GOLDEN & GREGORY
2800 ONE ATLANTIC CENTER
1201 WEST PEACHTREE STREET
ATLANTA, GA 30309-3450
Appeal No. 1998-2813
Application No. 08/463,203
16
Claims
19. A medical device for tissue regeneration formed using a
solid free-form fabrication method comprising a matrix of
successive layers of biocompatible polymeric material having
interconnected pores extending throughout the matrix suitable of
seeding or ingrowth of cells.
21. A medical device for bone regeneration formed using
three dimensional printing comprising a matrix of successive
layers of biocompatible composite material having interconnected
pores extending throughout the matrix suitable for seeding or
ingrowth of cells, having pore size of at least five to forty
microns in diameter,
wherein the methods comprises
a) spreading a first dispersion of a resorbable powder
selected from the group consisting of calcium phosphate,
hydroxyapatite, and calcium carbonate onto a bed,
b) printing a layer comprising a second dispersion of
biocompatible polymer or composite powder in a solvent which
binds the first powder to the second biocompatible polymer or
composite powder at locations where it is desired to have walls,
and
c) repeating step b until the desired matrix is made.
Shereece
Appeal No. 1998-2813
Application No. 08/463,203
APJ FRANKFORT
APJ KEYBOARD()
APJ KEYBOARD()
AFFIRMED-IN-PART
Prepared: July 18, 2003