Ex Parte Nyhart

Board of Patent Appeals and Interferences

Mar 9, 2009

10045550 (B.P.A.I. Mar. 9, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ELDON H. NYHART, JR.
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Appeal 2008-6231
Application 10/045,550
Technology Center 3700
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Decided:1 March 9, 2009
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Before TONI R. SCHEINER, LORA M. GREEN, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s final rejection of claims 57-65 and 104-106.2 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).

Appeal 2008-6231
Application 10/045,550

STATEMENT OF THE CASE
The claims are directed to a method of delivering a compound. Claim
57 is the only independent claim on appeal, and reads as follows:
57. A method for providing a compound to a system comprising:
providing a compound releasably captured within a matrix material,
the compound being releasable upon receiving an energy input, a source of
energy, and a controller operatively connected to the source and using a
control signal to operate the source;
preparing a control signal using fractal mathematics;
placing the matrix material and captured compound in fluid
communication with the system; and
operating the controller with the control signal and providing energy
to the matrix material sufficient to release a portion of the compound into the
system.

The Examiner relies on the following evidence:
Altman US 6,086,582 July 11, 2000
Chupakhin US 6,028,068 Feb. 22, 2000
Donatsch US 4,789,673 Dec. 6, 1988
Ellinwood, Jr. US 4,146,029 Mar. 27, 1979

We reverse.
ISSUE
The Examiner finds that claims 57-59, 62, 64, 105, and 106 are
anticipated by Altman.
Appellant contends that Altman does not inherently teach a fractal
based control signal.
2 Claims 107-140 are also pending, but stand withdrawn from consideration
(App. Br. 1).
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Thus, the issue on Appeal is: Has the Examiner established by a
preponderance of the evidence that the control signal of Altman is
necessarily prepared using fractal mathematics?

FINDINGS OF FACT
FF1 The invention relates to a method of releasing a compound into an
intravenous environment (Spec. 1).
FF2 According to the Specification:
The method includes providing a compound releasably captured
within a matrix material, the compound being releasable upon
receiving an energy input. The method includes placing the
matrix material and captured compound in fluid communication
with a fluid which flows in a biological space of the biological
unit. Energy is provided to the matrix material sufficient to
release a portion of the compound, and the compound is
released into the biological unit in an irregular pattern.

(Id. at 4.)
FF3 The Specification discusses preparing a control signal using fractal
mathematics (id. at 32-36).
FF4 The Specification teaches that many natural systems exhibit structure
characterized by chaotic behavior, and that fractional Brownian motion
(fBm) may be used as a model for many random fractals found in nature (id.
at 32).
FF5 Thus, according to an embodiment of the invention, “the application
of energy to the catheter assembly is applied according to a 1-dimensional
algorithm to synthesize fBm fractal Brownian motion.” (Id. at 33.)
FF6 The Examiner rejects claims 57-59, 62, 64, 105, and 106 under 35
U.S.C. § 102(e) as being anticipated by Altman (Ans. 3).
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FF7 The Examiner cites Altman for teaching a method of providing a
compound to a system (id. at 4).
FF8 As to the control signal, the Examiner finds that Altman teaches a
controller that “senses electrical activity of the heart and responds by
injecting delivery of the drug or goes into monitoring mode depending on
the sensed electrical activity.” (Id. (citing Altman, col. 14, ll. 7-47; col. 14,
l. 66-col. 15, l. 47).)
FF9 The Examiner finds that the control signal of Altman is prepared by
using fractal mathematics. According to the Examiner:
It is being considered that the computer/controller is inherently
producing fractal mathematics since fractals are generated by an
iterative process - doing the same thing again and again. The
computer/controller has this factor built in. Fractals also have
the property that when you magnify them they still look much
the same. The device of Altman produces the same control
signal to release the compound. Further, if fractal mathematics
is considered to be calculations based on fractions, any integer
is considered to be a fraction or could be represented as a
fraction.

(Ans. 7.)
FF10 Specifically, Altman teaches an implantable transient drug delivery
catheter, wherein the catheter is implanted into a suitable site so as to deliver
antiarrhythmic agents as well as sense electrical activity near the device
(Altman, col. 14, l. 66-col. 15, l. 6).
FF11 The catheter of Altman is connected to an external controller and
power source (id. at col. 15, ll. 6-12). The device senses cardiac activity
through the surface of the drug delivery structure, and when the heart
experiences an arrhythmic event, “the controller identifies the event and the
energy source which delivers the drug to the heart.” (Id. at ll. 12-16.)
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FF12 The Examiner rejects claim 60 under 35 U.S.C. § 103(a) as being
obvious over the combination of Altman and Chupakhin (Ans. 4).
FF13 Chupakhin is relied upon for the limitation of the use of an anesthetic
as the therapeutic agent, with the system being a neurological system (id. at
4-5).
FF14 The Examiner rejects claim 61 under 35 U.S.C. § 103(a) as being
obvious over the combination of Altman and Donatsch (id. at 5).
FF15 Donatsch is relied upon for the limitation of the use of a
neurottransmitter as the therapeutic agent, with the system being a
neurological system (id.).
FF16 The Examiner rejects claim 63 under 35 U.S.C. § 103(a) as being
obvious over Altman (id. at 6).
FF17 The Examiner concludes that it would have been obvious to modify
the frequency to about 1Hz as it would be routine optimation (id.).
FF18 The Examiner rejects claims 65 and 104 under 35 U.S.C. § 103(a) as
being obvious over the combination of Altman and Elinwood, Jr. (id.).
FF19 Elinwood, Jr. is relied upon for teaching a programmable controller
for a medication system (id.).

PRINCIPLES OF LAW
It is axiomatic that in order for a prior art reference to serve as an
anticipatory reference, it must disclose every limitation of the claimed
invention, either explicitly or inherently. In re Schreiber, 128 F.3d 1473,
1477 (Fed. Cir. 1997). Under the principle of inherency, when the prior art
reference is silent as to the limitation asserted to be inherent, it need be clear
that the missing descriptive matter is necessarily present in the thing
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described in the reference, and that it would be so recognized by the
ordinary artisan. Continental Can Co. v. Monsanto Co., 948 F.2d 1264,
1268 (Fed. Cir. 1991).
Inherency, however, may not be established by
probabilities or possibilities. The mere fact that a certain thing
may result from a given set of circumstances is not sufficient.
(Citations omitted.) If, however, the disclosure is sufficient to
show that the natural result flowing from the operation as
taught would result in the performance of the questioned
function, it seems to be well settled that the disclosure should
be regarded as sufficient.

Id. at 1269 (quoting In re Oelich, 666 F.2d 578, 581 (CCPA 1981)).

ANALYSIS
Appellant argues that “Altman fails to teach a fractal based control
signal.” (App. Br. 3.) According to Appellant, while the Examiner’s
position is that “‘the computer/controller of Altman is inherently producing
fractal mathematics since fractals are generated by an iterative process –
doing the same thing again and again,’” merely “[s]howing that a computer
has an iterative process does not teach, necessitate, or inherently include that
fractal mathematics are thereby utilized.” (Id. at 4.)
We agree with Appellant. Altman does not teach or suggest the use of
fractal mathematics to prepare the control signal. Altman only teaches that
the controller releases drug when the heart experiences an arrhythmic event
(FF11). The Specification clearly differentiates fractal mathematics as a
particular mathematical model with distinct algorithms which are not simply
iterative (FF 4-5). In addition, while the Examiner asserts that Altman is
inherently using fractal mathematics as fractals are generated using an
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iterative process, the Examiner has not provided and evidence or scientific
reasoning that the ordinary artisan would conclude that any iterative process
necessarily uses fractal mathematics.

CONCLUSIONS OF LAW
We conclude that the Examiner has not established by a
preponderance of the evidence that the control signal of Altman is
necessarily prepared using fractal mathematics.
We are thus compelled to reverse the rejection of claims 57-59, 62,
64, 105, and 106 under 35 U.S.C. § 102(e) as being anticipated by Altman.
As the remainder of the rejections do not remedy the deficiencies of the
anticipation rejection, we are also compelled to reverse the remaining
rejections on appeal, that is, the rejection of claim 60 under 35 U.S.C. §
103(a) as being obvious over the combination of Altman and ; the rejection
of claim 61 under 35 U.S.C. § 103(a) as being obvious over the combination
of Altman and Donatsch; the rejection of claim 63 under 35 U.S.C. § 103(a)
as being obvious over Altman; and the rejection of claims 65 and 104 under
35 U.S.C. § 103(a) as being obvious over the combination of Altman and
Elinwood, Jr.
REVERSED

lp

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