Ex parte TEEPLE

Board of Patent Appeals and Interferences

Feb 17, 1998

08232502 (B.P.A.I. Feb. 17, 1998)

Application for patent filed April 25, 1994. According1
to the appellant, the application is a continuation of
Application No. 07/986,189, filed December 7, 1992, now
abandoned.
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journal and (2) is not binding precedent of the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. 14
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte EDWARD TEEPLE, JR.
____________
Appeal No. 97-0943
Application No. 08/232,5021
____________
ON BRIEF
____________
Before CALVERT, FRANKFORT, and NASE, Administrative Patent
Judges.
NASE, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal from the examiner's final
rejection of claims 1, 2, 5 through 7, 9, 10 and 33 through
Appeal No. 97-0943 Page 2
Application No. 08/232,502
Claims 2, 5, 7 and 33 have been amended subsequent to2
the final rejection.
35. Claims 11, 12, 15 through 21, 24, 25 and 27 through 322
have been withdrawn from consideration under 37 CFR § 1.142(b)
as being drawn to a nonelected invention. Claims 3, 4, 8, 13,
14, 22, 23 and 26 have been canceled.
We AFFIRM, however, for reasons explained infra, we have
denominated our affirmance a new ground of rejection under 37
CFR § 1.196(b).
BACKGROUND
The appellant's invention relates to a method of
preparing a drug solution. Claim 1 is representative of the
subject matter on appeal and a copy of claim 1 is attached to
this decision.
The prior art references of record relied upon by the
examiner as evidence of obviousness under 35 U.S.C. § 103 are:
Rubalcaba, Jr. 4,898,578 Feb.
6, 1990
Appeal No. 97-0943 Page 3
Application No. 08/232,502
The examiner withdrew the specific objections to claims3
2, 7 and 32 (sic, 33?) in the Advisory Action of April 1,
1996.
Hamacher 5,102,408 Apr. 7,
1992
Claims 1, 2, 5 through 7, 9, 10 and 33 through 35 stand
rejected under 35 U.S.C. § 112, second paragraph, as being
indefinite for failing to particularly point out and
distinctly claim the subject matter which the appellant
regards as the invention.3
Claims 1, 2, 5 through 7, 9, 10 and 33 through 35 stand
rejected under 35 U.S.C. § 103 as being unpatentable over
Rubalcaba in view of Hamacher.
Rather than reiterate the conflicting viewpoints advanced
by the examiner and the appellant regarding the § 103 and §
112, second paragraph, rejections, we make reference to the
final rejection (Paper No. 7, mailed December 11, 1995) and
the examiner's answer (Paper No. 13, mailed October 25, 1996)
Appeal No. 97-0943 Page 4
Application No. 08/232,502
for the examiner's complete reasoning in support of the
rejections, and to the appellant's brief (Paper No. 12, filed
July 16, 1996) for the appellant's arguments thereagainst.
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. As a consequence of our review, we make the
determinations which follow.
The indefiniteness issue
We sustain the rejection of claims 1, 2, 5 through 7, 9,
10 and 33 through 35 under 35 U.S.C. § 112, second paragraph,
as being indefinite for failing to particularly point out and
distinctly claim the subject matter which the appellant
regards as the invention, although not for the reasons
specifically stated by the examiner.
Appeal No. 97-0943 Page 5
Application No. 08/232,502
According to the examiner (final rejection, pp. 2-4), it
is not clear that claim 1 is claiming the method disclosed in
the specification. Specifically, the examiner questioned why
the concentration being determined in step C of claim 1 is
based on the standardized rate range of infusion, not the
maximum rate of infusion as set forth in the specification.
Claims are considered to be definite, as required by the
second paragraph of 35 U.S.C. § 112, when they define the
metes and bounds of a claimed invention with a reasonable
degree of precision and particularity. See In re Venezia, 530
F.2d 956, 958, 189 USPQ 149, 151 (CCPA 1976).
Our review of claim 1 reveals that step C of claim 1
(i.e., "determining a required concentration of said at least
one drug based on a patient's weight, said dosage rate, amount
of said solution, and standardized rate range of infusion")
fails to set forth the metes and bounds of the claimed
invention with a reasonable degree of precision and
particularity for the following reasons.
Appeal No. 97-0943 Page 6
Application No. 08/232,502
As set forth in the specification, the weight of the drug
and hence its concentration is determinable when the specific
dosage rate, body weight, rate of infusion and amount (i.e.,
volume) of solution are known. However, in step C of claim 1,
the specific rate of infusion is not specified since step C
refers to the standardized rate range of infusion established
in step B of claim 1. Since the standardized rate range of
infusion is a variable, it is not possible to determine the
weight of the drug and hence its concentration. The appellant
states (Amendment filed May 11, 1996, Paper No. 8, page 2)
"the Examiner is correct in stating the maximum rate of
infusion is used to calculate the concentration." However,
step C of claim 1 does not recite that the maximum rate of
infusion is used to calculate the concentration, instead step
C of claim 1 incorrectly recites that the rate range of
infusion is used to calculate the concentration.
Likewise, the specific amount (i.e., volume) of solution
is not able to be specified since the drug has not yet been
mixed in the infusion bag. We read the preamble of claim 1 to
recite that the drug is part of the solution. Thus, the
Appeal No. 97-0943 Page 7
Application No. 08/232,502
The amendment amended claims 32 and 33 (not claims 334
and 34) to delete "predetermined."
specific amount (i.e., volume) of solution is not able to be
specified until the drug is mixed. We recognize that in the
appellant's disclosed method (specification, page 17) the drug
is mixed with another fluid in the bag, that the known amount
(i.e., volume) of the fluid in the bag is used to determine
the amount (i.e., volume) of drug to be added to the fluid in
the bag, that an amount (i.e., volume) of fluid is withdrawn
from the bag equivalent to the amount (i.e., volume) of drug
being added to the bag, and that thereafter the determined
amount (i.e., volume) of drug is mixed with the remaining
fluid in the bag. However, this is not the method recited in
the appealed claims.
As to the examiner's lack of antecedent objections to
claims 5 and 33, we believe the appellant's after final
amendments (Paper No. 8) to claims 5 and 33 overcome those
objections. However, the appellant failed to amend claim 344
to correct the antecedent objection. Additionally, we note
that claim 34 lacks antecedent basis for "said anesthesia."
Appeal No. 97-0943 Page 8
Application No. 08/232,502
Appeal No. 97-0943 Page 9
Application No. 08/232,502
37 CFR § 1.196(b)
Inasmuch as the basic thrust of our affirmance of the
35 U.S.C. § 112, second paragraph rejection differs from the
rationale advanced by the examiner for the rejection, we
hereby designate the affirmance to be a new ground of
rejection pursuant to 37 CFR § 1.196(b) to allow the appellant
a fair opportunity to react thereto (see In re Kronig, 539
F.2d 1300, 1302-03, 190 USPQ 425, 426-27 (CCPA 1976)).
The obviousness issue
Considering now the rejection of claims 1, 2, 5 through
7, 9, 10 and 33 through 35 under 35 U.S.C. § 103, we have
carefully considered the subject matter defined by these
claims. However, for reasons stated supra, no reasonably
definite meaning can be ascribed to certain language appearing
in the claims. As the court in In re Wilson, 424 F.2d 1382,
165 USPQ 494 (CCPA 1970) stated:
All words in a claim must be considered in judging the
patentability of that claim against the prior art. If no
reasonably definite meaning can be ascribed to certain
terms in the claim, the subject matter does not become
obvious --the claim becomes indefinite.
Appeal No. 97-0943 Page 10
Application No. 08/232,502
In comparing the claimed subject matter with the applied
prior art, it is apparent to us that considerable speculation
and assumptions are necessary in order to determine what in
fact is being claimed. Since a rejection based on prior art
cannot be based on speculation and assumptions, see In re
Steele, 305 F.2d 859, 862, 134 USPQ 292, 295 (CCPA 1962), we
are constrained to reverse, pro forma, the examiner's
rejection of claims 1, 2, 5 through 7, 9, 10 and 33 through 35
under 35 U.S.C. § 103. We hasten to add that this is a
procedural reversal rather than one based upon the merits of
the section 103 rejection.
CONCLUSION
To summarize, the decision of the examiner to reject
claims 1, 2, 5 through 7, 9, 10 and 33 through 35 under 35
U.S.C. § 103 is reversed and the decision of the examiner to
reject claims 1, 2, 5 through 7, 9, 10 and 33 through 35 under
35 U.S.C. § 112, second paragraph is affirmed, with the
affirmance constituting a new ground of rejection under 37 CFR
§ 1.196(b).
Appeal No. 97-0943 Page 11
Application No. 08/232,502
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. 53131, 53197 (Oct. 10, 1997), 1203
Off. Gaz. Pat. 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 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. . . .
Appeal No. 97-0943 Page 12
Application No. 08/232,502
No time period for taking any subsequent action in
connection with this appeal may be extended under 37 CFR
§ 1.136(a).
AFFIRMED; 37 CFR § 1.196(b)
IAN A. CALVERT )
Administrative Patent Judge )
)
)
)
) BOARD OF PATENT
CHARLES E. FRANKFORT ) APPEALS
Administrative Patent Judge ) AND
) INTERFERENCES
)
)
)
JEFFREY V. NASE )
Administrative Patent Judge )
Appeal No. 97-0943 Page 13
Application No. 08/232,502
THOMAS C. WETTACH
CINDRICH & TITUS
FOUR GATEWAY CENTER
20TH FLOOR
PITTSBURGH, PA 15222
Appeal No. 97-0943
Application No. 08/232,502
Page 1
APPENDIX
1. A method for preparing a solution with at least one
drug for an infusion bag for providing continuous infusion
into a patient, comprising the following steps:
a. determining a dosage rate for a maximum dosage at
a standardized maximum rate of infusion for said drug;
b. establishing a standardized titration rate range
of infusion;
c. determining a required concentration of said at
least one drug based on a patient's weight, said dosage rate,
amount of said solution, and standardized rate range of
infusion; and
d. mixing said drug into a bag of said solution in
the concentration determined in Step C.
APPEAL NO. 97-0943 - JUDGE NASE
APPLICATION NO. 08/232,502
APJ NASE
APJ FRANKFORT
APJ CALVERT
DECISION: AFFIRMED;
37 CFR § 1.196(b)
Prepared By: Delores A. Lowe
DRAFT TYPED: 09 Feb 98
FINAL TYPED: