Ex parte Rodsten

Board of Patent Appeals and Interferences

Jul 24, 2001

08784237 (B.P.A.I. Jul. 24, 2001)

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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and is not binding precedent of the Board.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. 21
UNITED STATES PATENT AND TRADEMARK OFFICE
________________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
________________
Ex parte CARSTEN B. RODSTEN
________________
Appeal No. 2000-1747
Application No. 08/784,237
________________
HEARD: July 11, 2001
________________
Before OWENS, WALTZ and DELMENDO, Administrative Patent
Judges.
WALTZ, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the
examiner’s final rejection of claims 1 through 14, which are
the only claims pending in this application.
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According to appellant, the invention is directed to an
improvement of a known process for coating medical devices
with hydrophilic coatings which comprises applying to a
substrate
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These separate rejections have been combined as one1
rejection although based on the two requirements of the first
paragraph of § 112, as noted, for ease of discussion.
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surface which does not have a hydrophilic coating a solution
of agents which will combine to form the hydrophilic coating
along with an osmolality promoting agent (Brief, pages 2-3).
Copies of illustrative claims 1 and 7, directed to the method
and the device produced, are attached as an Appendix to this
decision.
The examiner has relied upon the following references as
support for the rejections on appeal:
Lambert 4,585,666 Apr. 29, 1986
Johansson et al. (Johansson) 4,906,237 Mar. 6, 1990
Whitbourne 5,001,009 Mar. 19, 1991
Claims 1-14 stand rejected under 35 U.S.C. § 112, first
paragraph, for failing to fulfill the written description and
enablement requirements (Answer, page 7). Claims 1-3, 7-9,1
and 13-14 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Lambert or Whitbourne (Answer, page 8). Claims
1-14 stand rejected under 35 U.S.C. § 102(b) as anticipated by
Johansson (Answer, page 10). We reverse all of the examiner’s
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rejections for the reasons set forth in the Brief, Reply
Brief, and the reasons which follow.
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OPINION
A. The Rejections under 35 U.S.C. § 112, first paragraph
The examiner separately rejects all of the claims on
appeal for failure to meet the requirements of the written
description requirement and failure to meet the requirements
of the enablement requirement (see the Answer, page 7). The
written description and enablement requirements of § 112 are
separate and distinct. See Vas-Cath Inc. v. Mahurkar, 935
F.2d 1555, 1563,
19 USPQ2d 1111, 1117 (Fed. Cir. 1991). As recognized by the
examiner (Answer, page 7), the written description requirement
of § 112 requires that the applicant must convey with
reasonable clarity to those skilled in the art that, as of the
filing date sought, applicant was in possession of the
invention as now claimed. See Vas-Cath Inc., 935 at 1563, 19
USPQ2d at 1117. The initial burden of proof rests with the
examiner in establishing that appellant has not met the
written description requirement. See In re Alton, 76 F.3d
1168, 1175, 37 USPQ2d 1578, 1583 (Fed. Cir. 1996). However,
we determine that the examiner has not met this burden merely
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by criticizing the Example and Table in appellant’s
specification (Answer, pages 4-7). The examiner has not
presented any convincing evidence or reasoning that the
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written description does not convey with reasonable clarity to
one skilled in the art that appellant was in possession of the
invention as now claimed.
The initial burden of proof also rests with the examiner
to support a rejection for lack of enabling disclosure. See
In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed.
Cir. 1993). “Although not explicitly stated in section 112,
to be enabling, the specification . . . must teach those
skilled in the art how to make and use the full scope of the
claimed invention ‘without undue experimentation’ [Citations
omitted]." Wright, 999 F.2d at 1561, 27 USPQ2d at 1513. We
determine that the examiner has not met this burden merely by
showing that one example in appellant’s specification contains
“results of a somewhat schematic field test” which vary
according to the user’s perception (see the specification,
page 5, lines 29-30; page 7, lines 10-16). We determine that
the examiner has not explained why this example would have
necessitated undue experimentation to practice the invention
as now claimed.
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For the foregoing reasons and those set forth in the
Brief and Reply Brief, we determine that the examiner has not
met the initial burden of proof required to support the
rejections under
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the written description and enablement requirements of
35 U.S.C. § 112, first paragraph. Accordingly, the examiner’s
rejections of claims 1 through 14 under 35 U.S.C. § 112, first
paragraph, are reversed.
B. The Rejections under 35 U.S.C. § 102(b)
Under 35 U.S.C. § 102(b), a rejection for anticipation
requires that the prior art reference disclose, either
expressly or inherently, every limitation of the claims. See
In re King, 801 F.2d 1324, 1326, 231 USPQ 136, 138 (Fed. Cir.
1986). All claim limitations must be considered, including
the preamble of claims written in Jepson-type form. See Rowe
v. Dror, 112 F.3d 473, 479, 42 USPQ2d 1550, 1553 (Fed. Cir.
1997)(“the claim preamble defines not only the context of the
claimed invention, but also its scope”); and Pentec, Inc. v.
Graphic Controls Corp., 776 F.2d 309, 315, 227 USPQ 766, 770
(Fed. Cir. 1985)(“the claimed invention consists of the
preamble in combination with the improvement”). Thus even
though a Jepson-type claim results in an implied admission
that the preamble is conventional or known, the claim must be
considered as a whole.
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The term “amino acid” is a known chemical term2
representing various amino-containing aliphatic acids such as
glycine, leucine, etc. See Hackh’s Chemical Dictionary 44-45
(3d ed., The Blakiston Co., New York, 1953, copy not
attached). No acids, much less amino acids, are exemplified
at column 3, lines 18-22, of Lambert.
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The examiner finds that “Lambert discloses (3:3-31)
dissolving amino acids, etc. into the solution that forms the
hydrophilic layer” (Answer, page 8). Since appellant’s
specification discloses that amino acids are osmolality
promoting agents, the examiner asserts that the claimed
subject matter is anticipated by Lambert (id., citing page 3,
line 33 - page 4, line 2, of appellant’s specification).
However, the examiner’s factual basis is incorrect since
Lambert, at column 3, lines
3-31, discloses adding a catalyst for isocyanate curing which
may be chosen from different types of amines (see column 3,
lines
9-10 and 13-14). The exemplified amines taught by Lambert do
not include any amino acids. Accordingly, it is clear that2
the rejection of claims 1-3, 7-9, and 13-14 under 35 U.S.C.
§ 102(b) over Lambert cannot be sustained.
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The examiner finds that “Whitbourne discloses in examples
8, 17 and 18 mixing organic acid or inorganic acid into the
PVP and in example 5(e) using urea formaldehyde resin”
(Answer, page 9). The examiner does not identify where
Whitbourne teaches “organic acid or inorganic acid” but
considers the acetic acid of the aforementioned examples to be
an osmolality promoting agent in view of appellant’s
disclosure that organic acids are useful as osmolality
promoting agents (id., citing page 3, line 24 -
page 4, line 5, of appellant’s specification). However, as
correctly argued by appellant (Brief, page 14), appellant’s
specification first defines osmolality promoting agents and
then lists classes of compounds which may include these agents
(specification, page 3, lines 24-36). Appellant has
challenged the examiner’s finding that acetic acid is an
osmolality promoting agent (Brief, page 14) and Whitbourne
teaches that acetic acid is only used as a solvent for the
hydrophilic polymer (see column 3, lines 8-10). On this
record, the examiner has not met the burden of proof that the
acetic acid exemplified by Whitbourne meets the claimed
limitation of an “osmolality promoting agent.” Accordingly,
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the rejection of claims 1-3, 7-9, and 13-14 under 35 U.S.C.
§ 102(b) over Whitbourne cannot be sustained.
The examiner finds that Johansson teaches that an
osmolality promoting agent may be mixed with a hydrophilic
polymer (Answer, page 10, citing column 2, lines 15-24). In
view of the examiner’s claim interpretation that only the
“improvement” need be shown, the examiner asserts that the
claimed subject matter is anticipated by this disclosure of
Johansson even though the reference discloses that the
substrate already has a hydrophilic polymer coating before the
osmolality promoting agent is applied (id.). However, in view
of our claim construction as set forth above, all of the
limitations of the claim must be considered, including the
limitation that the method starts with a “substrate which was
not previously provided with a hydrophilic coating” (see claim
1 on appeal; see also claim 7, where the medical device
contains a single hydrophilic coating). With respect to
separately argued claims 4-6 and 10-12 (Brief, page 17), we
note that Johansson does not teach urea and that urea is not
“a well known organic salt” (see the Answer, page 11, and
Hackh’s Chemical Dictionary 882 (3d ed., The Blakiston Co.,
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New York, 1953, copy not attached)). For the foregoing
reasons, the rejection of the claims on appeal under 35 U.S.C.
§ 102(b) over Johansson is reversed.
C. Summary
The rejection of claims 1-14 under 35 U.S.C. § 112, first
paragraph, for failing to meet the written description
requirement, is reversed. The rejection of claims 1-14 under
35 U.S.C. § 112, first paragraph, for failing to meet the
enablement requirement, is reversed. The rejections of
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claims 1-3, 7-9, and 13-14 under 35 U.S.C. § 102(b) as
anticipated by Lambert or Whitbourne are reversed. The
rejection of claims 1-14 under 35 U.S.C. § 102(b) as
anticipated by Johansson is reversed.
The decision of the examiner is reversed.
REVERSED
TERRY J. OWENS )
Administrative Patent Judge )
)
)
)
)
THOMAS A. WALTZ ) BOARD OF PATENT
Administrative Patent Judge ) APPEALS AND
) INTERFERENCES
)
)
)
ROMULO H. DELMENDO )
Administrative Patent Judge )
TAW:clm
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Ostrolenk, Faber, Gerb & Soffen
1180 Avenue of the Americas
New York, NY 10036-8403
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APPENDIX
1. In a method of forming a hydrophilic and osmolality
promoting agent coating on the surface of a substrate which
was not previously provided with a hydrophilic coating
comprising applying, in one process step, a solution of agents
which will combine to form the hydrophilic coating to the
surface of the substrate and causing said agents to combine to
form the hydrophilic coating, the improvement which comprises:
incorporating into said solution at least one osmolality
promoting agent whereby the osmolality promoting agent is
applied to the substrate in the same process step as said
solution of agents.
7. In a medical device for introduction into a body
cavity comprising a substrate having a surface and a single
hydrophilic coating disposed on at least part of said surface
and also having at least one osmolality promoting agent
associated therewith, the improvement which comprises:
said osmolality promoting agent being incorporated in
said hydrophilic coating itself.
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