Ex Parte Gillis

Patent Trial and Appeal Board

May 28, 2013

11542221 (P.T.A.B. May. 28, 2013)

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.
11/542,221 10/04/2006 John R. Gillis 6777 4025
6858 7590 05/28/2013
BREINER & BREINER, L.L.C.
115 NORTH HENRY STREET
ALEXANDRIA, VA 22314
EXAMINER
SHAHNAN SHAH, KHATOL S
ART UNIT PAPER NUMBER
1645
MAIL DATE DELIVERY MODE
05/28/2013 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 PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JOHN R. GILLIS
__________

Appeal 2012-002780
Application 11/542,221
Technology Center 1600
__________

Before MELANIE L. McCOLLUM, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal
1
under 35 U.S.C. § 134 involving claims to a process
for automated evaluation of sterility test indicators. The Examiner rejected
the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm.

1
Appellant identifies the Real Party in Interest as SGM Biotech,
Inc. (App. Br. 2).
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Statement of the Case
Background
“This invention relates to automated procedures for monitoring
sterility test-indicators individually for results following intended exposure
of a test-ampoule to a selected microbial-biocidal treatment cycle” (Spec. 1 ¶
0002).
The Claims
Claims 1-9, 17, and 18 are on appeal. Claim 1 is representative and
reads as follows:
1. Process for automated-evaluation and authenticated
documentation of effectiveness, or absence thereof, of selected
individual microbial-biocidal treatment-cycles, comprising
A) providing a housing-structure, presenting
(i) individual test-cell receptacles, each for receiving an
individual biological indication (B-I) Test-Ampoule, for
(ii) evaluating, subsequent to intended exposure to a
designated microbial-biocidal treatment-cycle,
(iii) biocidal effectiveness, or absence thereof, of such
treatment-cycle on a B-I Test-Ampoule within an
individual housing-structure test-cell;
B) correlating
(i) size and configuration of an individual B-I
Test-Ampoule, with respect to
(ii) size and configuration of such an individual
receptacle,
(iii) inserting such Test-Ampoule into such correlated
size and configuration receptacle, for purposes of
C) biologically evaluating effectiveness following
completion of such selected microbial-biocidal treatment-cycle,
by
(i) automatically-controlling:
(a) heating within such housing-structure for
establishing incubation conditions,
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(b) establishing a selected incubation temperature
within such B-I Test-Ampoule, and
(ii) recording time of establishment of incubation
temperature, within
(iii) such correlated size and configuration B-1 Test
Ampoule, for
(a) evaluating intended microbial-biocidal results
within such Test-Indicator; or, alternatively -
(b) evaluating microbial-activity,
(iv) within such Test-Ampoule; and
(v) wherein each B-I Test-Ampoule in each test-cell is
evaluated by a separate source of radiant energy and a
photo-detector for said radiant energy.

The issues
A. The Examiner rejected claims 1-9, 17, and 18 under 35 U.S.C.
§ 103(a) as obvious over Bolea
2
and Gillis
3
(Ans. 4-5).
B. The Examiner rejected claims 1-9, 17, and 18 under 35 U.S.C. § 112,
first paragraph as failing to comply with the written description requirement
by incorporating new matter (Ans. 5-6).
A. 35 U.S.C. § 103(a) over Bolea and Gillis
The Examiner finds that
Bolea et al. teach a process and apparatus for automated-
evaluation and authenticated documentation of
effectiveness, or absence thereof, of selected individual
microbial-biocidal treatment-cycles, comprising providing a
housing-structure, presenting individual test-cell receptacles,
each for receiving an individual biological-indication (B-1)
test-Ampoule. (See abstract and claims). Bolea et al. teach
visible means such as fluorescence in response to biological

2
Bolea et al., US 6,025,189, issued Feb. 15, 2000.
3
Gillis, J., US 6,455,272 B1, issued Sep. 24, 2002.
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activity (see abstract). As to new added limitation in step(v),
Bolea also teaches separate source of energy that each B-1
test Ampoule is tested

(Ans. 4-5). The Examiner finds that “Bolea et al. do not teach Bromocresol
purple and spectroscopic quantitative measurement” (Ans. 5).
The Examiner finds that “Gillis teach Bromocresol purple, see claims
specially claim 3. Gillis teach spectroscopic quantitative measurement”
(Ans. 5).
The Examiner finds it obvious “to combine the teachings of Bolea et
al. and Gillis to obtain the instant invention because Bolea et al. teach an
apparatus which reads a plurality of biological indicators to determine the
efficacy of a plurality of sterilization cycles” (Ans. 5).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner‟s conclusion that Bolea and Gillis render claim
1 obvious?
Findings of Fact
1. Bolea teaches “a system for determining the efficacy of a
sterilization cycle. More specifically, the present invention relates to a
system for reading fluorescence from a biological sterility indicator in order
to determine the efficacy of the sterilization cycle” (Bolea, col. 1, ll. 15-19).
2. Bolea teaches that
An apparatus reads a plurality of biological indicators
contained in a biological indicator vessel (the indicator and
the vessel being collectively referred to as a BI) to determine
efficacy of a plurality of sterilization cycles. Each BI
exhibits fluorescence in response to biological activity
indicative of bacterial growth in the vessel. A plurality of BI
holders are each configured to receive one of the BIs. A
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carriage is controllably movable relative to the plurality of
BI holders to positions proximate each of the BI holders. A
radiation emitter is mounted on the carriage and is
positioned to impinge radiation on a BI received in a
selected BI holder. A fluorescence sensor is also mounted on
the carriage and is positioned to sense fluorescence
exhibited by the BI in the selected BI holder in response to
the radiation. A controller is coupled to the fluorescence
sensor to receive a fluorescence signal and to provide an
output signal indicative of the fluorescence sensed. The
controller is configured to control the position of the
carriage to intermittently position the carriage proximate
each of the BI holders then holding a BI. A memory is
coupled to the controller and is configured to receive and
store data indicative of the fluorescence of each BI based on
the fluorescence signals received by the controller.

(Bolea, col. 3, ll. 16-38.)
3. Bolea teaches that a “BI reading apparatus 10 includes housing
12, which provides a plurality of DI receiving wells 14” (Bolea, col. 4, ll.
24-26).
4. Bolea teaches that a “BI 22 is first placed in a sterilizer along
with the other devices or equipment to be sterilized. Then, the sterilization
cycle is performed. The sterilization cycle may typically include steam
sterilization, dry heat sterilization, or chemical or radiation sterilization
techniques.” (Bolea, col. 6, ll. 12-16.)
5. Bolea teaches that “[d]ifferent time frames, temperature
regimes and sterilization cycles require the use of different types of BIs, as is
known” (Bolea, col. 6, ll. 16-18).

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6. Bolea teaches that the
operator then, in one preferred embodiment, inputs into
reading apparatus 10 (preferably through operator interface
19) the particular type of BI being used as BI 22. This
accomplishes a number of things. First, the particular type of
BI being used indicates microprocessor 32 the correct set
point for the heater 48 or 50 associated with the reading well
14 into which the BI 22 will be placed. For instance, one
type of BI may require incubation at approximately 60° C.
while another type may require incubation at approximately
37° C. . . . In any case, microprocessor 32 preferably
controls the heaters to desired set points with closed loop
control

(Bolea, col. 6, ll. 20-32).
7. Bolea teaches that “based on the type of BI being used,
microprocessor 32 retrieves from memory corresponding fluorescent kinetic
behavior information for use in providing the efficacy output. The kinetic
information is preferably indicative of the fluorescent behavior of the
particular BI under circumstances in which the sterilization cycle to which it
was exposed has been efficacious and non-efficacious” (Bolea, col. 6, ll. 34-
40).
8. Bolea teaches that:
After the baseline reading is obtained, microprocessor 32
waits for a designated time out. The length of the time out
will correspond to the particular BI type being used, and
how fast spore growth activity is expected to occur . . . After
the desired time out, another florescence reading is taken
from the particular BI 22 . . . If microprocessor 32
determines that the second florescence reading exceeds the
baseline florescence reading by a statistically significant
amount, that means that a statistically significant amount of
biological activity (spore growth) has occurred in BI 22
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during the incubation cycle. Thus, the sterilization cycle has
not been efficacious. Microprocessor 32 therefore provides
an output to display panel 16 indicating that the sterilization
cycle has not been efficacious.

(Bolea, col. 8, ll. 14-42.)
9. Bolea teaches an embodiment where “a plurality of
independently controllable heaters are provided so that different types of
biological indicators can be incubated and read by a single system” (Bolea,
col. 3, ll. 43-46).
10. Figure 1 of Bolea is reproduced below:

“FIG. 1 is a perspective view of a biological indicator apparatus” (Bolea,
col. 3, ll. 56-57).
11. Bolea teaches that in “one preferred embodiment, a BI presence
sensor 52 is associated with each BI receiving well 14” (Bolea, col. 5, ll. 62-
63).
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12. Bolea teaches that “where the BI presence sensor is an electro-
optic sensor, such as an infrared detector, the radiation source of the detector
is shut off during fluorescence measurements” (Bolea, col. 16, ll. 6-9).
13. Bolea teaches that “in one preferred embodiment, as soon as
system 10 or system 14 is powered up, microprocessor 32 cycles through
each of the BI presence sensors to determine whether any of wells 14 are
populated with BIs” (Bolea, col. 16, ll. 14-17).
14. Bolea teaches a method where “the user must independably
[sic] chart the time when each BI was placed in the incubator, track the
duration that each BI is incubated, and record the results of the reading step
for each BI so as to chart the efficaciousness of each associated sterilization
cycle” (Bolea, col. 2, ll. 56-61).
15. Gillis teaches an indicator material which is bromcresol purple
(see Gillis, col. 12, l. 24).
16. Gillis teaches that “[m]ultiple early-load-release evaluations of
sterilizing effectiveness for both „dry‟ and „wet‟ sterilizer loads, are made
available by selective spectroscopic quantitative measurements of peak
absorption of electromagnetic radiation” (Gillis, abstract).
Principles of Law
Claim terms are interpreted using the broadest reasonable
interpretation in light of the Specification. See, e.g., In re Hyatt, 211 F.3d
1367, 1372 (Fed. Cir. 2000) (“[D]uring examination proceedings, claims are
given their broadest reasonable interpretation consistent with the
specification.”).
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“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Analysis
Claim interpretation is at the heart of patent examination because
before a claim is properly interpreted, its scope cannot be compared to the
prior art. In this case, the issue is drawn to the limitation “wherein each B-1
Test-Ampoule in each test-cell is evaluated by a separate source of radiant
energy and a photo-detector for said radiant energy” in claim 1, clause
(C)(v).
Appellant contends that Bolea does not teach “each test-cell is
evaluated by a separate source of radiant energy and a photo-detector
therefor” (App. Br. 10-11). Appellant contends that “[r]ather, Bolea
discloses a carriage for carrying one fluorescence signal and fluorescence
sensor for evaluating the multiple B-I holders. This carriage moves to each
specific B-I holder” (Reply Br. 3).
Clause (C)(v) in claim 1 does not impose any limitations on the source
of radiant energy or the type of photo detector. More importantly, clause
(C)(v) does not link itself to clause (C)(iii) by using either “said evaluation,”
“the evaluation,” or a different signal word indicating that the evaluation in
clause (C)(v) has antecedent basis in the “evaluating intended microbial-
biocidal results” or “evaluating microbial activity” of clause (C)(iii)(a) or
(C)(iii)(b). Appellant also does not identify, and we do not find, a specific
teaching in the Specification that limits the evaluation in clause (C)(v) to be
related to the evaluation in either clause (C)(iii)(a) or (C)(iii)(b).
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Therefore, claim 1 may broadly encompass performance of two
different evaluation steps, one step which simply requires “evaluating
intended microbial-biocidal results” and another step “wherein each B-I
Test-Ampoule in each test-cell is evaluated by a separate source of radiant
energy and a photo-detector for said radiant energy.”
Bolea teaches two different evaluation steps. As Appellant points out
(see App. Br. 9), Bolea teaches one step where a “fluorescence sensor is also
mounted on the carriage and is positioned to sense fluorescence exhibited by
the BI in the selected BI holder in response to the radiation” (Bolea, col. 3,
ll. 27-29; FF 2).
However, Bolea also teaches a second evaluation step where “a BI
presence sensor 52 is associated with each BI receiving well 14” (Bolea, col.
5, ll. 62-63; FF 11). Bolea teaches that “where the BI presence sensor is an
electro-optic sensor, such as an infrared detector, the radiation source of the
detector is shut off during fluorescence measurements” (Bolea, col. 16, ll. 6-
9; FF 12). Bolea teaches that “as soon as system 10 or system 14 is powered
up, microprocessor 32 cycles through each of the BI presence sensors to
determine whether any of wells 14 are populated with BIs” (Bolea, col. 16,
ll. 14-17; FF 13).
We agree with the Examiner that this second evaluation step
reasonably satisfies the requirements of clause (C)(v) in claim 1, since the BI
presence sensors, associated with each test location, are evaluated by their
own infrared detector and radiation source, which must be extinguished
during the first step evaluation using the fluorescence measurements (FF 11-
13).
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Appellant also contends that Bolea does not teach or suggest “an
apparatus which records the time of establishment of incubation temperature
within the B-I Test-Ampoule” (App. Br. 10).
We are not persuaded. Bolea teaches that after a “baseline reading is
obtained, microprocessor 32 waits for a designated time out. The length of
the time out will correspond to the particular BI type being used, and how
fast spore growth activity is expected to occur . . . . After the desired time
out, another florescence reading is taken from the particular BI 22” (Bolea,
col. 8, ll. 14-32; FF 8). Bolea also teaches a prior art method where “the
user must independably [sic] chart the time when each BI was placed in the
incubator, track the duration that each BI is incubated, and record the results
of the reading step for each BI so as to chart the efficaciousness of each
associated sterilization cycle” (Bolea, col. 2, ll. 56-61; FF 14).
Thus, given the teachings of Bolea, we conclude that either Bolea
teaches, or it would have been obvious over Bolea and Gillis, for the
baseline reading to occur when the BI was placed into the test cell (FF 8),
and to record the time of establishment in the microprocessor so that the
microprocessor would know when completion of the time out would occur
so as to be able to obtain the next fluorescence reading (FF 8). This is
consistent with the operation of known processes in the prior art (FF 14).
Conclusion of Law
The evidence of record supports the Examiner‟s conclusion that Bolea
and Gillis render claim 1 obvious.

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B. 35 U.S.C. § 112, written description
The Examiner finds that at “issue is the term „separate source‟. It is
the Examiner‟s opinion that the disclosure does not reasonably convey that
each „Test Ampoule‟ has its own separate source of radiant energy” (Ans.
6).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner‟s conclusion that the term “separate source”
represents new matter?
Findings of Fact
17. The Specification teaches that “[f]urther specific objects for
significantly-decreasing expected times for B-I evaluations of individual
Test-Ampoules are provided by utilizing selected radiant-energy-source
means and selected electrometric indicator means, for expediting evaluation
of microbial-status within a liquid nutrient-growth medium (NGM) which
remains sealed within an individual B-I Test-Ampoule” (Spec. 2-3 ¶ 0008).
18. The Specification teaches that “[m]ore specifically, augmenting
the rate of heating can decrease the time for evaluation of biocidal-status.
Also, present evaluations can be expedited utilizing transmitted radiant-
energy; radiant-energy technology teachings of the invention are described
in greater detail later herein” (Spec. 12 ¶ 00038).
19. The Specification teaches that a “microprocessor for each
radiant-energy analysis embodiment, is connected to measuring-components
within the housing-structure for reporting, signaling and recording purposes;
as well as, for radiant-energy analyses” (Spec. 17 ¶ 00049).

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20. Figure 4 of the Specification is reproduced below:

“FIGURE 4 is an enlarged schematic presentation for describing interacting
functional components arranged with respect to an individual-cell
with Test-Ampoule in place” (Spec 4 ¶ 00014).
21. The Specification teaches that the “schematic arrangement of
FIGURE 4 can be adapted for describing placement of colormetric radiant-
energy source and detector means; plus other functioning components,
which are interrelated with respect to each other, for decreasing the time
required for detecting a treatment-cycle failure, within a B-1 Test-Ampoule,
as held within an individual test-receptacle” (Spec. 15 ¶ 00045).
22. The Specification teaches that a “test-cell receptacle for each B-
I Test-Ampoule, and its heating means, are located within the housing-
structure; and, all measuring equipment is wired for functioning with each
respective test-cell receptacle; and, expedited radiant energy analyses,
enables decreasing the overall number of test-cells in a housing-structure
embodiment” (Spec 17 ¶ 00050).
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23. The Specification teaches “FIGURE 4 is an enlarged schematic
presentation for describing interacting functional components arranged with
respect to an individual-cell with Test-Ampoule in place, for decreasing the
time required, in accordance with the invention, for evaluating the
microbial-status of such B-1 Test-Ampoule” (Spec. 4 ¶ 00014).
Principles of Law
“[T]he written description requirement does not demand either
examples or an actual reduction to practice; a constructive reduction to
practice that in a definite way identifies the claimed invention can satisfy the
written description requirement” Ariad Pharmaceuticals, Inc. v. Eli Lilly and
Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010).
“[I]t is the specification itself that must demonstrate possession. And
while the description requirement does not demand any particular form of
disclosure, … or that the specification recite the claimed invention in haec
verba, a description that merely renders the invention obvious does not
satisfy the requirement” Id. (citations omitted).
Analysis
As we interpreted claim 1, clause (C)(v) above, the claim requires that
“each test-cell is evaluated by a separate source of radiant energy and a
photo-detector for said radiant energy” (Claim 1). While the Specification
discusses the use of radiant energy sources (FF 17-18) as well as measuring
components (FF 19), none of the locations cited by Appellant (see App. Br.
8; FF 17-22) provide descriptive support for multiple “separate” sources of
radiant energy for each distinct test cell as required by claim 1. “When no
such description can be found in the specification, the only thing the PTO
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can reasonably be expected to do is to point out its nonexistence.” Hyatt v.
Dudas, 492 F.3d 1365, 1370 (Fed. Cir. 2007).
Appellant contends that “Figure 4 illustrates one test-cell of the
multiple test-cells. In this Figure, there is shown a separate source of radiant
energy 28 and a separate photo-detector 30. Accordingly, the specification
clearly indicates that each test-cell includes a separate source of radiant
energy and a separate photo-detector for detecting said radiant energy”
(Reply Br. 2).
We are not persuaded. The brief description of Figure 4 states that
“FIGURE 4 is an enlarged schematic presentation for describing interacting
functional components arranged with respect to an individual-cell with Test-
Ampoule in place, for decreasing the time required, in accordance with the
invention, for evaluating the microbial-status of such B-1 Test-Ampoule”
(Spec. 4 ¶ 00014; FF 23). There is no teaching identified by Appellant that
supports the position that Figure 4 illustrates one test cell of a multi-cell unit.
Even if we agree with Appellants that Figure 4 illustrates a portion of a
multi-cell unit, the figure and accompanying text do not indicate whether
each test cell comprises its own radiant energy source and detector. While it
may be obvious that each test cell of Figure 4 could include its own radiant
energy source and detector, “a description that merely renders the invention
obvious does not satisfy the [written description] requirement.” Ariad, 598
F.3d at 1352.
Conclusion of Law
The evidence of record supports the Examiner‟s conclusion that the
term “separate source” represents new matter.
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SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C.
§ 103(a) as obvious over Bolea and Gillis. Pursuant to 37 C.F.R.
§ 41.37(c)(1)(vii)(2006), we also affirm the rejection of claims 2-9, 17, and
18 as these claims were not argued separately
We affirm the rejection of claims 1-9, 17, and 18 under 35 U.S.C.
§ 112, first paragraph as failing to comply with the written description
requirement by incorporating new matter.

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).

AFFIRMED

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