Ex parte Wang

Board of Patent Appeals and Interferences

Aug 20, 1998

07796023 (B.P.A.I. Aug. 20, 1998)

Application for patent filed November 22, 1991. According to appellant, the1
application is a division of Application 07/063,968, filed June 19, 1987, now Patent No.
5,110,595, granted May 5, 1992, which is a continuation-in-part of Application
07/016,845, filed February 20, 1987, now abandoned.
1
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today (1) was not written for
publication in a law journal and (2) is not binding precedent of the Board.
Paper No. 26
UNITED STATES PATENT AND TRADEMARK OFFICE
_____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
_____________
Ex parte PAUL YAO-CHEUNG WANG
_____________
Appeal No. 93-3228
Application 07/796,0231
______________
ON BRIEF
_______________
Before WILLIAM F. SMITH, Administrative Patent Judge, and
McKELVEY, Senior Administrative Patent Judge, and WALTZ,
Administrative Patent Judge.
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 7 through 14, 21 through
Appeal No. 93-3228
Application 07/796,023
2
25 and 28 through 31, which are all of the claims remaining in
this application.
According to appellant, the invention is directed to a
bioerodible preparation implant with sustained action achieved
by compressing an admixture of a solid active agent with solid
lipid powder (brief, page 2).
Claim 7 is illustrative of the subject matter on appeal
and is reproduced below:
7. A bioerodible preparation implant with sustained
action which consists essentially of a compressed admixture of
an effective amount of solid bioactive polypeptide with lipid
powder, with the said lipid powder being selected from the
group consisting of glycerides, waxes, long-chain fatty acids
or derivatives, phospholipids, sphingolipids, cerebrosides,
terpenes, non-hormonal steroids or a combination thereof.
The examiner has relied upon the following references:
Kent 4,452,775 Jun.
5, 1984
Kidron 4,579,730 Apr. 1,
1986
Jang 4,882,167 Nov.
21, 1989
Nakagame et al. (EP ‘949) 0 143 949 Jun. 12,
1985
(Published European Patent Application)
Appeal No. 93-3228
Application 07/796,023
3
Claims 7-11, 14, 21, 22, 25 and 28-31 stand rejected
under 35 U.S.C. § 102(b) as anticipated by Kent. Claim 7
stands rejected under 35 U.S.C. § 102(b) as anticipated by EP
‘949. Claims 7 and 8 stand rejected under 35 U.S.C. § 102(b)
as anticipated by Kidron. Claims 7-13, 21-24 and 28-31 stand
rejected under 35 U.S.C. § 103 as unpatentable over Jang in
view of Kent. We vacate all of the stated rejections and,
pursuant to the provisions of 37 CFR § 1.196(b), enter a new
ground of rejection of claims 7-14, 21-25 and 28-31 under 35
U.S.C. § 112, second paragraph, for failing to particularly
point out and distinctly claim the subject matter which
applicant regards as his invention. We also include a
statement under 37 CFR
§ 1.196(c).
OPINION
A. The New Ground of Rejection Under 37 CFR §
1.196(b)
The limitations of appealed claim 7 are that the implant
is bioerodible with sustained action and ?consists essentially
of? a compressed admixture of an effective amount of a solid
Appeal No. 93-3228
Application 07/796,023
The examiner has used the word “somatotropin” and the term “growth hormone”2
interchangeably (answer, page 3, line 3). Appellant has not contested this usage.
317 F.2d 951, 954, 137 USPQ 893, 896 (CCPA 1963). See also In re DeLajarte,3
337 F.2d 870, 873-74, 143 USPQ 256, 258 (CCPA 1964), discussed on pages 3-4 of the
brief, and Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948).
4
bioactive polypeptide with lipid powder. The lipid powder may
be, inter alia, solid lipids, cholic acid, or preferably
cholesterol (specification, page 8, lines 2-19). The
bioactive polypeptide may be insulin or somatotropin (id.,2
page 1, lines 10-14, and page 3, lines 2-3).
A major point of contention between appellant and the
examiner is the meaning or scope of the claimed term
“consisting essentially of” (brief, pages 3-5, and the answer,
pages 3 and 9-11). The meaning of the phrase “consisting
essentially of” is well settled. The CCPA in In re
Janakirama-Rao defines “consisting essentially of” as3
follows:
The word “essentially” opens the claims to
the inclusion of ingredients which would
not materially affect the basic and novel
characteristics of appellant’s compositions
as defined in the balance of the claim...
(emphasis in original).
Appeal No. 93-3228
Application 07/796,023
See the specification, page 8, lines 25-28, page 9, lines 13-25, and Examples4
1-5 on pages 11-21.
5
In construing the phrase “consisting essentially of” in
appellant’s claims, it is necessary and proper to determine
whether the specification reasonably supports a construction
which would include the materials of the cited prior art. See
In re Herz, 537 F.2d 549, 551, 190 USPQ 461, 463 (CCPA 1976).
Appellant’s specification, under the heading “Summary of the
Invention”, states that the invention is that “lipid powder is
simply admixed with a suitable amount of bioactive
macromolecule, and compressed into a disc or rod without any
other components.” (specification, sentence bridging pages 7
and 8, emphasis added). From the remainder of appellant’s
specification, including the examples, there is no disclosure
or teaching that any components can be employed in the implant
other than the claimed solid bioactive polypeptide and lipid
powder. The legal standard for4
definiteness under paragraph two of 35 U.S.C. § 112 is whether
a claim reasonably apprises those of skill in the art of its
scope. See Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 927
Appeal No. 93-3228
Application 07/796,023
6
F.2d 1200, 1217, 18 USPQ2d 1016, 1030 (Fed. Cir. 1991). An
otherwise definite claim may take on an unreasonable degree of
uncertainty upon a reading of the specification disclosure.
See In re Moore, 439 F.2d 1232, 1235 n.2, 169 USPQ 236, 238
n.2 (CCPA 1971). Where, as here, there is an ambiguity
between the well settled meaning of “consisting essentially
of” and the construction of the claimed subject matter as
explicitly described in the specification, it is apparent that
one of ordinary skill in the art would not be reasonably
apprised of the scope of the claims. If appellant discloses
in the specification that no components are present in the
implant other than the bioactive macromolecule and the lipid
powder, but the well accepted meaning of the claim includes
other components as long as the basic and novel
characteristics of the claimed composition are not materially
affected, appellant is not
particularly pointing out and distinctly claiming the subject
matter he regards as his invention as required by the second
paragraph of 35 U.S.C. § 112.
For the foregoing reasons, we enter a new ground of
Appeal No. 93-3228
Application 07/796,023
7
rejection pursuant to 37 CFR § 1.196(b) of claims 7-14, 21-25
and 28-31 under 35 U.S.C. § 112, second paragraph.
B. Statement Under 37 CFR § 1.196(c)
All of the prior art applied by the examiner in rejecting
the claims on appeal contains components other than a
bioactive macromolecule and a lipid powder (see the analysis
of the references on pages 3-6 of the answer). Because the
subject matter defined by the claims is not clear, it is not
possible to assess whether this subject matter would have been
anticipated under § 102 or unpatentable under § 103. See In
re Steele, 305 F.2d 859, 862-63, 134 USPQ 292, 295-96 (CCPA
1962). Accordingly, we have vacated all four prior art
rejections.
The claims on appeal, if amended to read “consisting of”
instead of the presently claimed phrase “consisting
essentially of”, would avoid the foregoing new ground of
rejection under 35 U.S.C. § 112, second paragraph. The term
“consisting of” has the accepted meaning of closing the claim
to the inclusion of materials other than those recited except
Appeal No. 93-3228
Application 07/796,023
See Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948), and cases cited in5
footnote 3 supra.
8
for impurities ordinarily associated therewith. The5
insertion of “consisting of” into the claims on appeal would
obviate the new ground of rejection entered above since the
scope of the amended claims would be consistent with the
disclosure and teachings of the specification. The examiner
should re-evaluate the patentability of the subject matter in
any amended claims in view of the above remarks and the prior
art.
The examiner and appellant should reconcile the scope of
the language of claims 7 and 8, if amended pursuant to our
statement under 37 CFR § 1.196(c), with the language of
dependent claims 11 and 29-31. Specifically, the kit of
claims 11 and 31 and the bioerodible preparation of claims 29
and 30 all recite the term ?comprises? but these claims
ultimately depend on claims 7 and 8. The meaning or scope of
the term ?comprises? is well settled. The term ?comprises?
leaves the claim open for the inclusion of unspecified
Appeal No. 93-3228
Application 07/796,023
See Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948). See also In re Baxter,6
656 F.2d 679, 686-87, 210 USPQ 795, 802-03 (CCPA 1981).
9
ingredients even in major amounts. Therefore, upon6
amendment, the examiner and appellant should reconcile the
scope of the claims.
This decision contains a new ground of rejection pursuant
to 37 CFR § 1.196(b)(amended effective Dec. 1, 1997, by final
rule notice, 62 Fed. Reg. 53,131, 53,197 (Oct. 10, 1997), 1203
Off. Gaz. Pat. & Trademark Office 63,122 (Oct. 21, 1997)). 37
CFR
§ 1.196(b) provides that, “A new ground of rejection shall not
be considered final for purposes of judicial review.”
37 CFR § 1.196(b) also provides that the appellant,
WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise
one of the following two options with respect to the new
ground of rejection to avoid termination of proceedings
(§ 1.197(c)) as to the rejected claims:
(1) Submit an appropriate amendment of
the claims so rejected or a showing of
facts relating to the claims so rejected,
or both, and have the matter reconsidered
by the
examiner, in which event the application
Appeal No. 93-3228
Application 07/796,023
10
will be remanded to the examiner. . . .
(2) Request that the application be
reheard under § 1.197(b) by the Board of
Patent Appeals and Interferences upon the
same record. . . .
37 CFR § 1.196(c) provides:
Should the decision of the Board of Patent
Appeals and Interferences include an
explicit statement that a claim may be
allowed in amended form, appellant shall
have the right to amend in conformity with
such statement which shall be binding upon
the examiner in the absence of new
references or grounds of rejection.
A statement pursuant to 37 CFR § 1.196(c) has been made
in this decision. A time period in which appellant may file
an amendment for the purpose stated in § 1.196(c) is hereby
set to expire TWO MONTHS FROM THE DATE OF THIS DECISION.
No time period for taking subsequent action in connection
with this appeal may be extended under 37 CFR § 1.136(a).
VACATED - 37 CFR § 1.196(b) and (c)

)
WILLIAM F. SMITH )
Administrative Patent Judge )
)
Appeal No. 93-3228
Application 07/796,023
11
)
) BOARD OF PATENT
FRED E. McKELVEY, Senior )
Administrative Patent Judge ) APPEALS AND
)
)
) INTERFERENCES
THOMAS A. WALTZ )
Administrative Patent Judge )
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