Ex Parte Popp

Board of Patent Appeals and Interferences

Jan 30, 2012

12313804 (B.P.A.I. Jan. 30, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/313,804 11/25/2008 Shane M. Popp 5073
7590 01/30/2012
SMP Logic Systems
Intellectual Property Department
3460 Barry Avenue
Los Angeles, CA 90066
EXAMINER
GARLAND, STEVEN R
ART UNIT PAPER NUMBER
2121
MAIL DATE DELIVERY MODE
01/30/2012 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte SHANE M. POPP
____________

Appeal 2012-001071
Application 12/313,804
Technology Center 2100
____________

Before CARLA M. KRIVAK, THOMAS S. HAHN, and
BRADLEY W. BAUMEISTER, Administrative Patent Judges.

KRIVAK, Administrative Patent Judge.
Dissenting-In-Part Opinion filed by BAUMEISTER, Administrative Patent
Judge.

DECISION ON APPEAL
Appellant appeals under 35 U.S.C. § 134(a) from a final rejection of
claims 1-18. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.

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STATEMENT OF THE CASE
Appellant’s claimed invention is a method for monitoring a
pharmaceutical manufacturing process (Abstract).
Independent claim 1 is reproduced below.
1. A method for monitoring a pharmaceutical manufacturing process
using at least a dry heat sterilizer, said method comprising:
a) deriving an algorithm implemented in computer executable
instructions that performs data analysis on said
pharmaceutical manufacturing process using at least a dry
heat sterilizer:
b) performing “logic analysis” on said algorithm;
c) performing “software safety code analysis” on said
algorithm;
d) performing “software safety design analysis” on said
algorithm;
e) performing “software safety requirements analysis” on said
algorithm;
f) performing “software safety test analysis” on said algorithm;
g) integrating the said algorithm into a pharmaceutical
manufacturing process whereby actual monitoring of the
manufacturing process is attained.

REJECTIONS
The Examiner rejected claims 1-6 under 35 U.S.C. § 103(a) based
upon the teachings of Hickey (US 2004/0123864 A1), IEEE (IEEE
Standard for Software Safety Plans, IEEE Std. 1228-1994, 1994, pp. i-v, 1-
17), and Aikus (US 5,603,894).
The Examiner rejected claims 7-18 under 35 U.S.C. § 103(a) based
upon the teachings of Duhaime (US 5,901,879), Hickey, IEEE, and Schmidt
(US 2004/0006486 A1).

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ANALYSIS
Claims 1-6
The Examiner finds Hickey teaches pharmaceutical production
(Hickey ¶ [0126]; Ans. 5). The Examiner further finds Appellant’s claim 1
does not specify a type of manufacturing process, rather it only requires
using a dry heat sterilizer during a portion of the process. The Examiner
finds support for this assertion in column 12, lines 46-65 of Appellant’s
patent.
1
(Ans. 7)
Appellant contends the “Examiner’s reference to the instant
specification at col. 12, lines 46-65 does not provide a broad definition of
what can be regarded as a pharmaceutical manufacturing process” (App. Br.
9; Reply Br. 2-3). Appellant points out, this portion of the Specification
“relates to the type of hardware devices that may be used in a
pharmaceutical manufacturing process” in that it lists the types of hardware
that can be used (Reply Br. 2; App. Br. 9). Appellant further asserts
Hickey’s paragraph [0126] does not disclose pharmaceutical manufacturing.
Rather, this paragraph teaches dispensing dry powder substances in a
manufacturing process, not the manufacture of the dry powder
(pharmaceutical) (App. Br. 8, 10; Reply Br. 3). We agree with Appellant
that Hickey does not teach a pharmaceutical manufacturing process; it
teaches a manufacturing process of a device (paragraph [0001]), and is, thus,
outside the scope of the present invention (App. Br. 14). Therefore, claim 1,
and dependent claims 2-6, is not obvious over the combination of Hickey,
IEEE, and Aikus.

1
Appellant’s patent, US 7,444,197 B2 to Popp, from which this Reissue
arises, is referenced throughout this Opinion.
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Claims 7-18
Appellant argues claims 7-18 together as a group (App. Br. 14-19;
Reply Br. 8-11). Independent claim 7 is selected as representative of this
group. See 37 C.F.R. § 41.37(c)(1)(vii).
The Examiner finds Duhamie discloses all the elements of Appellant’s
independent claims 7 and 13 except Duhamie does not specifically disclose a
computer using a computer program, a software safety plan for insuring the
software safety, and using time stamps and an audit trail. The Examiner
relies on Hickey, IEEE, and Schmidt for these elements, respectively. (Ans.
9-10)
Appellant argues Duhamie uses mixing tanks to inject water to dilute
a solid powder, thus, merely diluting an already produced medication.
Therefore, Appellant asserts, Duhamie is not directed to a pharmaceutical
manufacturing process. (App. Br. 17; Reply Br. 4) Further, Appellant
asserts IEEE teaches developing a software plan and does not relate to
integrating an algorithm into a pharmaceutical manufacturing process. We
do not agree.
The Examiner cites column 4, line 43 to column 5, line 6 of Duhamie
as disclosing a pharmaceutical manufacturing system using a pure water
formula and employing an algorithm implemented on computer executable
instructions (Ans. 13). Particularly, column 4, lines 51-54 of Duhamie states
data is collected on “the medicine to be produced” or “the quantity of liquid
required to make a particular medicinal mixture.” Further, Appellant
expressly defines “[d]rug product” as “a finished dosage form, for example,
tablet, capsule, solution . . .” (emphasis added) (col. 8, ll. 37-42). Thus,
Appellant’s argument that “Duhamie makes no mention of manufacturing”
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is without merit as Duhamie discloses producing a medicine or medicinal
mixture (App. Br. 17).
Further, Duhamie discloses a computer 34 (e.g., Fig. 1).
Data collection means (not shown) are used to collect data and
transmit it to the computer 34 concerning either the quantity of
water to be dispensed, or the medicine to be produced; in the
latter case, a computerized data base must be accessed to
determine the quantity of liquid required to make a particular
medicinal mixture.
(col. 4, ll. 49-54). As such, Duhaime provides “an algorithm implemented in
computer executable instructions that performs analysis on data compiled
from said pharmaceutical manufacturing process using at least a pure water
system,” as required by claim 7.
Accordingly, combining Duhamie with Hickey’s control system,
which also provides “process controls by the monitoring, feedback, analysis,
and adjustment of the operation inputs to the process to provide more
reliable and repeatable processes,” discloses a computer performing
analysis, as claimed. IEEE teaches implementing a software safety plan
(“software safety requirements analysis”), as recited in Appellant’s claims
and as defined in Appellant’s patent (col. 7, ll. 34-36).
Schmidt was cited for disclosing a time stamped audit trail and can be
used in a “production process” (Ans. 14; Schmidt Abstract and ¶ [0053]).
Appellants have provided no evidence or arguments rebutting this assertion
other than stating Schmidt does not relate to pharmaceutical manufacturing
(App. Br. 17). Appellants have, therefore, not demonstrated the Examiner
erred in finding claims 7-18 obvious over the combination of Duhamie,
Hickey, IEEE, and Schmidt.
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DECISION
The Examiner’s decision rejecting claims 1-6 is reversed.
The Examiner’s decision rejecting claims 7-18 is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R.§ 1.136(a)(1)(iv)(2010).

AFFIRMED-IN-PART

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BAUMEISTER, Administrative Patent Judge, DISSENTING-IN-PART
I join the Majority in affirming the Examiner’s rejection of claims 7-
18. I respectfully dissent from the Majority’s reversal of the Examiner’s
obviousness rejection of claims 1-6.
The Majority reverses the rejection of claims 1-6 based upon
resolving the narrow issue argued by the Examiner and Appellant – whether
Hickey teaches a pharmaceutical manufacturing process. I agree with the
Majority that Hickey cannot be reasonably interpreted as teaching a
pharmaceutical manufacturing process. However, this fact is not dispositive
of whether the cited prior art renders the claims obvious.
“Before considering the rejections . . ., we must first [determine the
scope of] the claims . . . .” In re Geerdes, 491 F.2d 1260, 1262 (CCPA
1974). In the present case, Appellant provides the following express
definitions of the terms used in limitations b) though f) of claim 1:
“[L]ogic analysis” means evaluates the safety-critical
equations, algorithms, and control logic of the software
design. . . .
“[S]oftware safety code analysis” means verification that
the safety-critical portions of the design are correctly
implemented in the code.
“[S]oftware safety design analysis” means verification
that the safety-critical portion of the software design correctly
implements the safety-critical requirements and introduces
no new hazards.
“[S]oftware safety requirements analysis” means analysis
evaluating software and interface requirements to identify
errors and deficiencies that could contribute to a hazard.
“[S]oftware safety test analysis” means analysis
demonstrating that safety requirements have been correctly
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implemented and that the software functions safely within its
specified environment.
(Spec. col. 6, ll. 44-45; col. 7, ll. 27-40).
These definitions make clear that each of the noted claim terms only
require evaluating, verifying, or analyzing the software design. No
requirement exists in the claims or the Specification’s definitions that these
steps be performed by additional or separate software. As such, step a) of
claim 1 reads on providing computer hardware and/or software
(“implementing in computer executable instructions”) that performs data
analysis on a pharmaceutical manufacturing process using at least a dry heat
sterilizer. Steps b) though f) read on either (1) mentally verifying that this
computer code that performs step a) is written so as to perform as intended,
or, at least, (2) debugging this computer code. Step g) requires using the
computer that implements the algorithm in the verified or debugged code for
monitoring a pharmaceutical manufacturing process.
Turning to the cited art, Aikus discloses a method and apparatus for
sterilizing a pharmaceutical composition (Abstract). In that the
pharmaceutical is not ready for consumption until it is sterilized, Aikus can
be said to be directed to “a pharmaceutical manufacturing process” as recited
by claim 1. To achieve the sterilization, Aikus employs a heat exchanger
(Abstract) that can be based upon either radiant energy or electrical energy
(resistive heating) (col. 3, ll. 35-39). Aikus’s method entails measuring
temperatures in the heat exchanger; calculating a coefficient of heat transfer
for the sterilization system using temperature measurements; calculating a
degree of sterilization; and adjusting the temperature of the heat exchanger
to minimize degradation of the pharmaceutical composition (Abstract).
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These measurements and calculations are performed by a computer (col. 9,
ll. 27-39). The disclosure of a computer that operates for an intended
purpose includes an inherent or implicit disclosure that the computer’s
software has been validated and debugged. Alternatively, even assuming
arguendo that such an additional disclosure is not inherently or implicitly
contained within the express disclosure of a computer, it nonetheless would
have been obvious to one of ordinary skill in the art at the time of the
invention to have debugged computer software and verified that the
computer works as intended. This is all that the language of claim 1
requires. As such, Aikus, alone, discloses, or at least renders obvious, all of
the limitations required by claim 1.
For these reasons, I would affirm the Examiner’s obviousness
rejection of claims 1-6. See In re Meyer, 599 F.2d 1026, 1031 (CCPA 1979)
(noting that obviousness rejections can be based on references that happen to
anticipate the claimed subject matter).

kis