Ex Parte Arora

Board of Patent Appeals and Interferences

May 20, 2009

10131778 (B.P.A.I. May. 20, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________
Ex parte ARUN ARORA
____________________
Appeal 2009-003435
Application 10/131,778
Technology Center 3600
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Decided1: May 21, 2009
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Before MURRIEL E. CRAWFORD, JOESPH A. FISCHETTI, and
KEVIN F. TURNER, Administrative Patent Judges.

TURNER, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF CASE
Appellant seeks our review under 35 U.S.C. § 134 of the Final
Rejections of claims 11-16. We have jurisdiction under 35 U.S.C. § 6(b).

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).

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SUMMARY OF THE DECISION
We AFFIRM.
THE INVENTION
Appellant’s claimed invention relates to a method for converting drug
prescriptions to a universal reference range common to a plurality of drug
prescriptions (Spec. p. 4, ll. 12-14).
Independent claim 11, which is deemed to be representative,
reads as follows:
11. A method for converting drug dosages to
prevent overdose, comprising the steps of:
defining a common medication reference range;
assigning dosages of first and second drugs to
respective values within the common medication
reference range;
prescribing a particular dosage of the first drug;
identifying a value within the common medication
reference range for the particular dosage; and
permitting prescription fulfillment with a dosage of
the second drug which corresponds the dosage of the first
drug using the common medication reference range.

THE REJECTION
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Francis 6,978,286 B2 Dec. 20, 2005
Andersson 5,934,273 Aug. 10, 1999

The Examiner rejected claims 11-16 under 35 U.S.C. § 103(a) as
being obvious over Francis in view of Andersson.
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Rather than repeat the arguments of Appellant or the Examiner, we
make reference to the Briefs and the Answer for their respective details.
Only those arguments actually made by Appellant have been considered in
this decision. Arguments that Appellant did not make in the Briefs have not
been considered and are deemed to be waived. See 37 C.F.R.
§ 41.37(c)(1)(vii).

ISSUES
1) Has Appellant shown that the Examiner erred in establishing that
Francis and Andersson disclose or suggest the feature of assigning dosages
of first and second drugs to respective values within the common medication
reference range, as recited in independent claim 11?
2) Has Appellant shown that the Examiner erred in establishing that
Francis and Andersson disclose or suggest the feature of permitting
prescription fulfillment with a dosage of the second drug which corresponds
the dosage of the first drug using the common medication reference range, as
recited in independent claim 11?

FINDINGS OF FACT
The record supports the following findings of fact (FF) by a
preponderance of the evidence.
1) Francis is directed to “[a] handheld medication dosage
calculator (100) and method for comparing an inputted, ordered
medication dosage with a known medication dosage range in a
database. . . .” (Abs.) Francis discloses converting the drug amount
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available into an equivalent number that is in a desired unit of
measurement. (col. 7, ll. 46-59).
2) Francis discloses that, “Conversions to the desired unit of
measurement will be automatically performed by the computing
mechanism 250 and displayed on the display screen 204 for the
handheld medication dosage calculator…” (col. 7, ll. 52-59).
3) Francis discloses “[w]hile calculating the dose, the quantity
of the selected drug ordered is checked against the recommended
range limits for the particular drug selected from the drug database
file.” (col. 15, ll. 32-35).
4) Andersson is directed to a system for dispensing a clinically
effective dose of an inhalable, pharmaceutically active compound.
Andersson discloses that, “…in any assessment of efficiency
comparing different drugs, equipotent doses of pharmaceutically
active compounds should be directly compared.” (col. 5, ll. 4-6).
5) Andersson discloses that, “…these recommended doses can
be reduced when the system of the invention, rather than an MDI,
(Metered Dose Inhaled) [sic] is used to dispense the drugs. For
example, the metered dose of each of salbutamol, budesonide and
terbutaline may be reduced by a factor of two, compared to the
metered dose dispensed from an MDI for an equivalent clinically
therapeutic effect, in accordance with the present invention.” (col. 5,
ll. 3-14).
6) Appellant describes a “common medication reference range”
as, “[b]y converting the dosage ranges or the acquired values 120 for
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Isordril and Plendril to a common medication reference range 140 the
risk of overdose in minimized.” (Spec. p. 12, ll. 11-12).
7) We take “a common medication reference range” as being a
medication dosage which has been converted from some value into a
common, defined dosage in order to prevent overdose.

PRINCIPLES OF LAW
“Section 103 forbids issuance of a patent when ‘the differences
between the subject matter sought to be patented and the prior art are such
that the subject matter as a whole would have been obvious at the time the
invention was made to a person having ordinary skill in the art to which said
subject matter pertains.’” KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 406
(2007). The question of obviousness is resolved on the basis of underlying
factual determinations including (1) the scope and content of the prior art,
(2) any differences between the claimed subject matter and the prior art, (3)
the level of skill in the art, and (4) where in evidence, so-called secondary
considerations. Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17-
18 (1966). See also KSR, 550 U.S. at 407 (“While the sequence of these
questions might be reordered in any particular case, the [Graham] factors
continue to define the inquiry that controls.”)
In KSR, the Supreme Court held that “[t]he combination of familiar
elements according to known methods is likely to be obvious when it does
no more than yield predictable results.” Id. at 416. The Court explained:
When a work is available in one field of endeavor, design
incentives and other market forces can prompt variations of it,
either in the same field or a different one. If a person of
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ordinary skill can implement a predictable variation, § 103
likely bars its patentability. For the same reason, if a technique
has been used to improve one device, and a person of ordinary
skill in the art would recognize that it would improve similar
devices in the same way, using the technique is obvious unless
its actual application is beyond his or her skill.
Id. at 417.
The operative question in this “functional approach” is thus “whether
the improvement is more than the predictable use of prior art elements
according to their established functions.” Id. In rejecting claims under 35
U.S.C. § 103(a), the examiner bears the initial burden of establishing a prima
facie case of obviousness. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir.
1992). See also In re Piasecki, 745 F.2d 1468, 1472 (Fed. Cir. 1984). Only
if this initial burden is met does the burden of coming forward with evidence
or argument shift to the Appellants. Id. at 1472. Obviousness is then
determined on the basis of the evidence as a whole and the relative
persuasiveness of the arguments. See Oetiker, 977 F.2d at 1445; See also In
re Piasecki, 745 F.2d at 1472.

ANALYSIS
Appellant argue claims 11-16 as a group2. We treat claim 11 as
representative. See 37 C.F.R. § 41.37(c)(1)(vii).

2 A statement which merely points out what a claim recites will not be
considered an argument for separate patentability of the claim. See, 37
C.F.R. § 41.37(c)(vii).
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ISSUE 1
Appellant argues that Francis and Andersson, “whether taken alone or
in combination, fail to disclose or suggest the feature of assigning dosages of
first and second drugs to respective values within the common medication
reference range, as recited in independent claim 11.” (App. Br. 4).
However, Francis discloses outputting an equivalent amount of the
drug in a preferred unit of measurement that is converted to the desired unit
of measure and displayed on the screen (FF 1, 2). Francis further discloses
that while calculating the dosage of the selected drug ordered, it is checked
against the recommended range limits for the particular drug selected from
the drug database file (FF 3). With regard to the “common medication
reference range,” since the claim does not provide clear boundaries as to the
scope of what a common medication reference range consists of, and the
Specification provides no clear definition (FF 6), we construe the limitation
according to its broadest reasonable interpretation as a medication dosage
which has been converted from some value into a common, defined dosage
in order to prevent overdose (FF.7). Thus, in performing these steps, Francis
assigns dosages of drugs to respective values within the common medication
reference range.
Even assuming that Francis does not explicitly disclose “assigning
dosages of first and second drugs to respective values within the common
medication reference range,” a person of ordinary skill in the art would
appreciate from a reading of Francis and Andersson, that when assigning
dosages of first and second drugs, equipotent doses of pharmaceutically
active compounds should be directly compared (FF 3, 4). Thus, a person of
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ordinary skill in the art would have known this from Andersson and applied
this technique to Francis when outputting an equivalent amount of the drug
in order to assign the dosages to respective values within the common
medication reference range. Therefore, Appellant’s argument is not
persuasive as to error in the rejection.

ISSUE 2
Appellant argues that Francis and Andersson, “whether taken alone or
in combination, also fail to disclose or suggest the feature of permitting
prescription fulfillment with a dosage of the second drug which corresponds
to the dosage of the first drug using the common medication reference range,
as recited in independent claim 11.” (App. Br. p. 5). Specifically, Appellant
argues, “Andersson et al, do not teach or suggest the use of Drug B instead
of Drug A. As such, there is no drug conversion as recited in claim 11.”
(App. Br. p. 7). Appellant additionally argues, “[t]he main point of
Andersson et al. is that less of one particular drug is required when using the
allegedly efficient inhaler system taught by Andersson et al.” (Rep. Br. p. 4)
We disagree with Appellant’s characterization of Andersson and find
that there would have been a drug conversion in Andersson. (FF 4, 5).
Andersson specifically discloses reducing by a factor of two, the dosage
required for an equivalent clinically therapeutic effect (FF 5) and that “…in
any assessment of efficiency comparing different drugs, equipotent doses of
pharmaceutically active compounds should be directly compared.” (FF 4).
This comparison of different drugs and subsequent reduction in dosages
would have required a conversion between the dosages of the different drugs
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in order to arrive at the reduced dosage. Thus, a person of ordinary skill in
the art would know from Andersson to apply this comparison and
conversion technique to Francis since Francis too determines medication
dosages checked against the recommended range limits for the particular
drug. (FF 1, 2, 3) Therefore, Appellant’s argument is not persuasive as to
error in the rejection.

CONCLUSION OF LAW
We conclude that Appellant has not shown that the Examiner erred in
rejecting claims 11-16 under 35 U.S.C. § 103(a) as being unpatentable over
Francis in view of Andersson.

DECISION
We AFFIRM the rejection of claims 11-16.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

rvb
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