Ex parte Spencer

Board of Patent Appeals and Interferences

Mar 23, 2001

08803779 (B.P.A.I. Mar. 23, 2001)

1 The amendment filed April 28, 1999 (Paper No. 9) after the final
rejection has not been entered (see Paper No. 10).
1
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publication and is not binding precedent of the Board.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. 17
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte DUDLEY W. C. SPENCER
____________
Appeal No. 2000-0605
Application No. 08/803,779
____________
ON BRIEF
____________
Before McQUADE, BAHR and LAZARUS, Administrative Patent Judges.
BAHR, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal from the examiner's final
rejection of claims 2, 7-10 and 13-17.1 Claims 3-6, the only
other claims pending in the application, stand withdrawn from
further consideration under 37 CFR § 1.142(b) as being
directed to a non-elected invention.
Appeal No. 2000-0605
Application No. 08/803,779
2
BACKGROUND
The appellant's invention relates to a container for use
in medical applications where a medical fluid is transferred
through tubing communicating with the container. Claim 13 is
illustrative of the invention and is reproduced in the
appendix to appellant's brief.
The prior art references of record relied upon by the
examiner in rejecting the appealed claims are:
Hillier et al. (Hillier) 4,048,254 Sep. 13,
1977
Kobayashi et al. (Kobayashi) 4,670,510 Jun. 2,
1987
Mueller et al. (Mueller) 4,816,343 Mar. 28,
1989
The following rejections are before us for review.
(1) Claims 2, 7-10 and 13-17 stand rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Hillier in view of
Kobayashi.
(2) Claims 2, 7-10 and 13-17 stand rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Kobayashi in view of
Mueller.
Reference is made to the brief and reply brief (Paper
Nos. 13 and 15) and the answer (Paper No. 14) for the
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Application No. 08/803,779
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respective positions of the appellant and the examiner with
regard to the merits of these rejections.
OPINION
In reaching our decision in this appeal, we have given
careful consideration to the appellant's specification and
claims, to the applied prior art references, and to the
respective positions articulated by the appellant and the
examiner. For the reasons which follow, we cannot sustain the
examiner's rejections.
The prior art
Hillier discloses thermoplastic polymers comprising
nonvulcanized radial block copolymers of the diene-aryl
substituted olefin butadiene-styrene type blended with other
polymeric or copolymeric materials, such as polyesters,
polyester urethane polymers and polyether urethane polymers,
to form plastic compositions which have sufficient clarity,
hardness, tensile strength and elongation to be readily
adaptable for use in composing plastic materials for contact
with parenteral fluids. Hillier teaches that the disclosed
compositions have such a high degree of clarity that they can
replace polyvinylchloride (PVC) as a material in the forming
Appeal No. 2000-0605
Application No. 08/803,779
4
of medical plastic products such as tubing, drip chambers,
injection reseal devices and other parenteral administration
equipment. Additionally, Hillier intimates that the disclosed
composition will have low alkaline extraction values so that
ingredients in the composition are not extracted into the
fluids to be administered. See col. 1, lines 7-42.
Kobayashi discloses a polyester type copolymer
composition comprising a polyester ether mixed with a
copolymer of ethylene with methacrylic acid neutralized with a
metallic ion to a methacrylate salt (col. 1, lines 33-40; col.
3, lines 22-43). The resulting composition has greatly
improved moldability, mechanical characteristics (strength,
elongation and frictional characteristics), heat resistance
and transparency (col. 5, lines 1-13). Consequently,
according to Kobayashi, the composition can be used for
various utilities, such as injection moldings, blow moldings
and extrusion moldings useful as parts of various machines
(e.g., name plates, automobile parts, switches, holders,
hooks, packings, etc.), coatings and the like (col. 5, lines
14-19).
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Application No. 08/803,779
5
Mueller discloses a multi-layer flexible film for use as
a replacement for PVC in forming pouches to supply liquids
such as medical solutions for parenteral administration.
These pouches should be collapsible, transparent, strong and
capable of resisting high temperatures required for heat
sterilization of their contents. The film comprises a sealant
layer of an ethylene propylene copolymer or modified ethylene
propylene copolymer, a core layer of a very low density
polyethylene and an outer layer of a flexible polyester or
copolyester (copolymer of polyether and polyethylene
terephthalate; a poly-ether-ester). Mueller discloses
blending a high molecular weight stabilizer such as IrganoxTM
1010 available from Ciba-Geigy Corporation into the polyester
or copolyester outer layer prior to extrusion of the film to
limit the migration of extractables from the outer layer into
a medical solution contained in the pouch (col. 3, lines 52-
61).
Rejection (1)
Claim 13, the sole independent claim on appeal, recites a
container for use in an assembly adapted for transferring
medical fluid, wherein the container is made from a
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Application No. 08/803,779
6
composition consisting essentially of an ionomeric modified
poly-ether-ester material containing from 1% to 50% by weight
ionomer, said poly-ether-ester being a block copolymer
containing both polyether and ester blocks modified by an
ionomer, said ionomer being a copolymer of ethylene with a 1-
10% by weight methacrylic acid converted to methacrylate salt.
The examiner concedes that the composition disclosed by
Hillier is not the composition recited in independent claim
13. However, the examiner takes the position that it would
have been obvious to one of ordinary skill in the art at the
time of appellant's invention to use the improved polyester
type copolymer composition taught by Kobayashi in the
polyester medical containers and devices disclosed in Hillier
in order to provide containers and devices with improved
moldability, mechanical properties and transparency (answer,
pages 3-4).
The test for obviousness is what the combined teachings
of the references would have suggested to one of ordinary
skill in the art. See In re Young, 927 F.2d 588, 591, 18
USPQ2d 1089, 1091 (Fed. Cir. 1991) and In re Keller, 642 F.2d
413, 425, 208 USPQ 871, 881 (CCPA 1981). Indeed, a prima
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Application No. 08/803,779
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facie case of obviousness is established where the reference
teachings would appear to be sufficient for one of ordinary
skill in the art having those teachings before him to make the
proposed combination or modification. See In re Lintner, 458
F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972).
In establishing a prima facie case of obviousness, it is
incumbent upon the examiner to provide a reason why one of
ordinary skill in the art would have been led to modify a
prior art reference or to combine reference teachings to
arrive at the claimed invention. See Ex parte Clapp, 227 USPQ
972, 973 (Bd. Pat. App. & Int. 1985). To this end, the
requisite motivation must stem from some teaching, suggestion
or inference in the prior art as a whole or from the knowledge
generally available to one of ordinary skill in the art and
not from the appellant's disclosure. See, e.g., Uniroyal,
Inc. v. Rudkin-Wiley Corp., 837 F.2d 1044, 1052, 5 USPQ2d
1434, 1439 (Fed. Cir.), cert. denied, 488 U.S. 825 (1988).
We recognize that Kobayashi teaches that the polyester
type block copolymer composition disclosed therein possesses
several desirable characteristics, such as improved
moldability, mechanical characteristics (strength, elongation
Appeal No. 2000-0605
Application No. 08/803,779
2 We note in this regard that the examiner's statement (answer, page 5)
that the material disclosed by Kobayashi is already well known in the medical
field is not supported by evidence. In making an obviousness rejection, the
examiner has the initial duty of supplying the requisite factual basis and may
(continued...)
8
and frictional characteristics), and transparency, which are
also recognized by Hillier as desirable for materials for
medical products used in administration of medical fluids. We
also appreciate that the composition taught by Hillier may
include polyesters, polyether or polyester urethane polymers,
or mixtures thereof, in substantial amounts. However, viewing
the teachings of Hillier and Kobayashi as a whole, as we are
obliged to do, we fail to perceive any teaching, suggestion or
incentive therein which would have motivated an artisan to
substitute the composition taught by Kobayashi for the
composition taught by Hillier in making medical products for
administration of parenteral fluids. In particular, we note
that the applications taught by Kobayashi for the disclosed
composition are quite divergent from the medical applications
taught by Hillier and that Kobayashi in no way teaches or
suggests that the composition disclosed therein is suitable as
a substitute for PVC or for making medical products of any
kind.2 From our perspective, the only suggestion for putting
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Application No. 08/803,779
2(...continued)
not, because of doubts that the invention is patentable, resort to
speculation, unfounded assumptions or hindsight reconstruction to supply
deficiencies in the factual basis. In re Warner, 379 F.2d 1011, 1017, 154 USPQ
173, 177-78 (CCPA 1967).
9
the selected pieces from the references together in the manner
proposed by the examiner is found in the luxury of hindsight
accorded one who first viewed the appellant's disclosure.
This, of course, is not a proper basis for a rejection. See
In re Fritch, 972 F.2d 1260, 1266, 23 USPQ2d 1780, 1784 (Fed.
Cir. 1992).
Accordingly, we shall not sustain the examiner's
rejection of independent claim 13, or of claims 2, 7-10 and
14-17 which depend from claim 13, as being unpatentable over
Hillier in view of Kobayashi.
Rejection (2)
In making this rejection, the examiner implicitly
concedes that Kobayashi does not teach or suggest the use of
the disclosed composition for use in containers of the type
recited in claim 13. The examiner, however, finds suggestion,
in the teaching by Mueller of blending a high molecular weight
stabilizer into the copolyester outer layer of a multi-layer
Appeal No. 2000-0605
Application No. 08/803,779
10
film pouch for containing medical fluids to limit the
migration of extractables from the outer layer, to (1) add a
high molecular weight stabilizer to the Kobayashi composition
to limit the extractables and (2) use the modified Kobayashi
composition to construct medical containers of the type
discussed by Mueller (answer, page 4). We find no such
suggestion.
In particular, we see no teaching or suggestion in either
Kobayashi or Mueller to use the particular composition taught
by Kobayashi in a container or pouch for administration of
medical fluids. Likewise, in the absence of any teaching or
suggestion to use the Kobayashi composition in an environment
where migration of extractables is a problem, it is not
apparent to us why one of ordinary skill in the art would have
been motivated to blend a high molecular weight stabilizer in
the Kobayashi composition.
In light of the above, we also shall not sustain the
examiner's rejection of claim 13, or of claims 2, 7-10 and 14-
17 which depend from claim 13, as being unpatentable over
Kobayashi in view of Mueller.
Appeal No. 2000-0605
Application No. 08/803,779
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We note appellant's reference on page 13 of the brief to
the Spencer declaration (Paper No. 7) filed December 11, 1998.
However, as we have determined, supra, that, with regard to
both rejection (1) and rejection (2), the applied references
are not sufficient to establish a prima facie case of
obviousness of the claimed subject matter, it is not necessary
for us to discuss the Spencer declaration herein.
CONCLUSION
To summarize, the decision of the examiner to reject
claims 2, 7-10 and 13-17 under 35 U.S.C. § 103(a) is reversed.
REVERSED
JOHN P. McQUADE )
Administrative Patent Judge )
)
)
)
) BOARD OF PATENT
JENNIFER D. BAHR ) APPEALS
Administrative Patent Judge ) AND
) INTERFERENCES
)
)
Appeal No. 2000-0605
Application No. 08/803,779
12
)
RICHARD B. LAZARUS )
Administrative Patent Judge )
Appeal No. 2000-0605
Application No. 08/803,779
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CONNOLLY AND HUTZ
P.O. BOX 2207
WILMINGTON, DE 19899-2207
JDB/ki