Ex Parte Sands

Board of Patent Appeals and Interferences

May 7, 2012

11620238 (B.P.A.I. May. 7, 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.
11/620,238 01/05/2007 Daniel L. Sands SME0002.US 8923
41863 7590 05/07/2012
TAYLOR IP, P.C.
P.O. Box 560
142. S Main Street
Avilla, IN 46710
EXAMINER
YOO, REGINA M
ART UNIT PAPER NUMBER
1775
MAIL DATE DELIVERY MODE
05/07/2012 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 SOLSTICE MEDICAL, LLC
____________________

Appeal 2011-007157
Application 11/620,238
Technology Center 1700
____________________

Before FRED E. McKELVEY, RICHARD E. SCHAFER, and
RICHARD TORCZON, Administrative Patent Judges.

SCHAFER, Administrative Patent Judge.
DECISION ON APPEAL
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Solstice Medical, LLC (Applicant) appeals an examiner’s decision rejecting
Claims 1-12. 35 U.S.C. §§ 6 and134. Applicant’s appeal challenges two findings
by the Examiner as to the teachings of the prior art. Because we do not see that the
Examiner erred in making those findings, we affirm.
The invention
The invention relates to an improvement in autoclave systems used to
sterilize reusable surgical instruments. The system includes a case to hold the
instruments; an autoclave to perform sterilization, and a controller to control the
autoclave sterilization process. The system relies on Radio Frequency
Identification (RFID) tags to wirelessly transmit signals representing a
“sterilization parameter” associated with one or more of the instruments to the
controller. Written Description1, 3:0009. 2 The tags may be attached to the
instruments or to the case. Written Description, 3:0009. The controller monitors
and automatically regulates at least one “physical parameter” of the autoclave
cycle based upon the data sent by the RFID tag. Written Description, 3:0009. The
controller may include electrical hardware and/or software suitable for
automatically controlling, for example, the time and temperature of the autoclave
cycle for adequate sterilization. Written Description , 4:0019. In one embodiment
of the system, the controller identifies instruments that are unsuitable for high
temperature sterilization or not intended to be reused and automatically prevents
the sterilization process:

1 All references to the Written Description are to the original copy filed on January 5, 2007, and
not to the version subsequently published on July 12, 2007.
2 In the notation #:#, the first number represents the column or page and the second number is the
line or the paragraph, respectively. Thus, Written Description, 2:0008 refers to page 2,
numbered paragraph 0008.
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In the event that instrument 14 is a disposable or heat sensitive
instrument, then RFID tag 30 provides a stop cycle output
signal which prevents controller 24 from initiating the
autoclaving process.
Written Description, 6:0024.
Claim 1, the sole independent claim is reproduced below:
1. An autoclave system for sterilizing surgical instruments,
comprising:
a sterilization case;
at least one surgical instrument within said case;
at least one RFID tag associated with said case,
each said RFID tag providing a wireless output
signal representing a sterilization parameter
associated with at least one said surgical
instrument; and
an autoclave for receiving said sterilization case,
said autoclave including a controller defining a
means for selectively controlling at least one
physical parameter of an autoclave cycle of said
autoclave, dependent upon said wireless output
signal from said RFID tag.
Brief, 16 (Claims Appendix) (emphasis added).
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Rejections
In the Answer the Examiner maintained the following rejections:
1. Claims 1-8 and 11-12 under 35 U.S.C. § 103(a) as unpatentable over the
combined teachings of Donati3 and Root.4
2. Claims 9-10 under 35 U.S.C. 103(a) as being unpatentable over the
combined teachings of Donati, Root and Chung.5
The Prior Art
Applicant does not argue the separate patentability of the subject matter of
dependent Claims 9 and 10, arguing instead that that subject matter is patentable
for the same reasons as Claim 1. Brief, 13. It is not necessary, therefore, to
discuss the Chung reference.
Donati
Donati discloses a system for providing information about surgical
instruments contained in a sealed sterilization case. Donati, 1:0002. The
instruments and the case may be sterilized by autoclaving. Donati, 1:0003 and
5:0050. Each surgical instrument includes an RFID tag that contains or is
associated with information related to that instrument. Donati, 2:0017. An
additional RFID tag may be attached to the exterior of the case to transmit data
about the instruments within the case. Donati, 4:0038-39. A wide assortment of
data may be transmitted by the RFID tags:
[T]he type of data transmitted by the RFID tags 7 and 8 and
case RFID tag 5 to the reader 2 may include the identification
of the medical instruments 6 to which the RFID tags 7 and 8 are
attached, the contents of the entire sterilization case 1, the

3 U.S. Patent Application Publication No. 2006/0145871.
4 U.S. Patent Application Publication No. 2004/0024290.
5 U.S. Patent Application Publication No. 2006/0055552.
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surgical technique associated with a particular medical
instrument 6 or group of medical instruments contained within
the sterilization case 1, surgical implants with which the
instrument 6 is to be used, the manufacturing history of a
particular medical instrument 6, how many times the instrument
6 has been sterilized, or any other relevant data associated with
the instruments, group of instruments, or case. Alternatively,
the RFID tags 7 and 8 may respond with a signal or signature
that keys or correlates to such information in a database in the
computer system or on a network such as the Internet or a local
network. One may see that a number of different types of data
may be conveyed with or keyed to information conveyed using
RFID tags 7 and 8 and case RFID tag 5. In the preferred
embodiment, the RFID tags 7 and 8 transmit or respond with
data that corresponds to the identification of a particular
medical instrument 6 and the case RFID tag 5 transmits data
corresponding to the identification and contents of a particular
sterilization case 1.
Donati, 4:0040.
Donati does not disclose a controller for the autoclave process.
Root
Root describes a system for monitoring and controlling the status and use of
reusable medical instruments, such as endoscopes. See generally, Root, 1:0004 -
5:0059. The instruments may include integral sensors and indicator systems.
Root, 7:0090. Root teaches that the sensors and indicators may be the
complimentary components of a passive induction system such as the Texas
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Instrument TIRIS® system. Root, 12: 0121. We understand the TIRIS® to be a
RFID system.
Root’s system includes a controller used for controlling the sterilization
process. Root, 13:0129 – 0132. Root describes a sterilization chamber that houses
a variety of sensors and devices for monitoring and controlling the sterilization
process. Root, 11-12:0117. These include equipment identity sensor 2100,
sterilization adjustment device 2200, a sterilization match sensor 2250, a
sterilization pressure sensor 2700, sterilization temperature sensor 2800, timer
2900 and communication device 2950. Root, 11-12:0117. The communication
device 2950 may be a wireless transmitter. Root, 12:0117. The communication
device transmits that information from the sensors to processor 1144. Root,
12:0117.
In one embodiment, Root describes controlling sterilization to avoid damage
to the instrument or make sure appropriate sterilization conditions are used. Thus,
Root’s system ascertains whether the instrument and sterilization equipment and
conditions are properly matched. Root, 12:0119. To this end, a match indicator
1165, embedded in the instrument, may include information read by sterilization
match sensor 2250. Root, 12:0120. Indicator 1165 and sensor 2250 may be
complementary components of the RFID TIRIS® system. Root, 12:0121. When
the medical equipment to be sterilized and the sterilization chamber do not match
the control system sends a signal to shut down the sterilization. Root, 12: 0122.
Root also teaches control and modification of the sterilization conditions
during the sterilization process. Thus, signals from the pressure sensor 2700,
temperature sensor 2800 and timer 2900 may be used to monitor and adjust the
sterilization conditions:
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pressure sensor 2700, temperature sensor 2800 and/or timer
2900 can be used to monitor and adjust the steam pressure,
steam temperature, and time of exposure (e.g., sensors 2700,
2800, and/or 2900 are used to control the conditions used
during sterilization of endoscope 1000) to assist in sterilizing
endoscope 1000 [under] appropriate conditions.
Root, 13:0132. The adjustments may be automated. Root, 13: 0131 (“In general,
pressure regulator 1145 can be manually controlled, automated, or both.”) and
13:0132 (“Sensors 2700, 2800, and/or 2900 can be manually operated, automated,
or both.”).
Issues
The Examiner found that Donati teaches the subject matter of Claim 1
except for the use of a controller for selectively controlling at least one physical
parameter of the autoclave cycle based upon the wireless signal from a RFID tag.
Answer, 6. The Examiner further found that Root shows that it was known in the
art to use a controller that adjusts the sterilization cycle based upon data sent by
RFID tags in order to ensure that the instrument is appropriate for the sterilization
device avoiding improper or ineffective sterilization conditions. Answer 6-7. The
Examiner concluded that it would have been obvious to combine Root’s controller
with Donati’s autoclave system. Answer, 7. The Examiner reasoned that one
skilled in the art would add the controller to ensure that the medical instrument
would not be damaged and to avoid ineffective sterilization conditions. Answer, 7.
Applicant argues that neither Donati nor Root disclose, teach or suggest a
RFID tag providing a wireless output signal representing a “sterilization
parameter.” Brief, 11-12. Applicant also argues that neither reference discloses,
teaches or suggests an autoclave having a controller that controls at least one
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physical parameter of the autoclave cycle based upon a signal received from the
RFID tag. Brief, 12.
The Examiner found that the wireless signals described by Donati include
signals representing sterilization parameters. Answer, 11. Referring to Donati at
4:0040, the Examiner specifically identifies the number of times the instrument
was sterilized, the number of instruments sterilized and the identification of the
medical instrument as sterilization parameters. Answer, 11. With respect to
Applicant’s argument that Root does not teach controlling a physical parameter for
the sterilization parameter, the Examiner found that whether the sterilization takes
place at all is a physical parameter of the sterilization cycle. Answer, 11-12. The
Examiner specifically notes Root’s teaching that controller 1144 controls whether
the sterilization cycle occurs or not based upon the signal from RFID tag 1165 and
match sensor 2250. Answer, 12. See Root, 12:0121 -0122.
Analysis
Claim 1
Sterilization Parameter
The Examiner found that both Donati and Root taught wirelessly
transmitting data representing sterilization parameters and specifically identified
that data. Thus, the Examiner identified the number of times the instruments were
sterilized, the identification of the instrument and the contents of the sterilization
case as “sterilization parameters” Answer, 7. With respect to the identification of
the instrument, the Examiner found that instrument identification was a
sterilization parameter used to keep an accurate record of the instrument’s history.
Answer, 11.
We think the Examiner’s findings are reasonable based upon the record
presented. Each of the factors recited by the Examiner appears to be reasonably
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pertinent to identifying the appropriate sterilization conditions. While Applicant
has argued, for example, that the identification of the instrument is not a
sterilization parameter, it has not provided an explanation why one having ordinary
skill in the art would not have considered instrument identification to be a
sterilization parameter. Applicant has not proffered a definition of “sterilization
parameter” in its specification, by way of extrinsic evidence, or by argument.
While the specification is directed to one having ordinary skill in the art and does
not have to define terms known to those working in the field, neither the Examiner
nor the members of this Board are persons of ordinary skill in the art. Where it
appears that the prior art teachings are facially within the scope of a word or phrase
and the applicant disagrees, the applicant is in the best position to explain the
meaning of the phrase and why the prior art does not come within its scope. We
have not been directed to any evidence or provided any reasoning explaining why
the data that identifies the instrument, the number of times an instrument has been
sterilized, or the sterilization status of the instrument would not be considered to be
sterilization parameters by one having ordinary skill in the art.
Selectively controlling at least one physical parameter of the
autoclave cycle dependent on the wireless signal from an
RFID tag
The Examiner found that Root describes controlling a physical parameter of
the autoclave cycle based upon a wireless signal from a RFID tag. Specifically,
the Examiner found that Root teaches sending a signal that identifies the
instrument to the controller which determines whether the sterilization chamber is
appropriate for sterilizing the particular instrument and whether the sterilization
should proceed. Answer, 12. The Examiner held that whether the sterilization
should proceed or not is a physical parameter of the sterilization cycle. Answer,
11-12. Applicant disagrees, but other than identifying time and temperature as
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physical parameters, provides no explanation why preventing sterilization from
proceeding when that sterilization would be inappropriate, is not a physical
parameter of the sterilization cycle.
Applicant has not directed us to evidence, or even provided an argument, on
the meaning “physical parameter” would have to one having ordinary skill in the
art. Applicant has only provided the contention that controlling whether the
sterilization cycle proceeds is not a physical parameter. Brief, 12. Additionally,
Applicant’s written description appears to be inconsistent with its contention. In
one of Applicant’s embodiments, the controller identifies instruments that are
unsuitable for high temperature sterilization or not intended to be reused and
automatically prevents the sterilization process from going forward:
In the event that instrument 14 is a disposable or heat sensitive
instrument, then RFID tag 30 provides a stop cycle output
signal which prevents controller 24 from initiating the
autoclaving process.
Written Description, 6:0024. We see no meaningful distinction between
Applicant’s embodiment and Root’s teaching of preventing sterilization if there is
a mismatch between the instrument and the sterilization conditions. Root,
12:0122.
Conclusion
Beyond the two issues discussed above, Applicant has not otherwise
challenged the basis for the Examiner’s holding that the subject matter of Claim 1
would have been obvious over the combined teachings of Donati and Root. Since
we do not see error in the challenged bases for that conclusion, we affirm the
rejection of Claim 1.
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Claims 2-12
With respect to Claims 2-12, Applicant relies on the arguments made with
respect to Claim 1. Brief, 13. We affirm the rejection of Claims 2-12 for the
reasons stated with respect to Claim 1.
DECISIONS
We affirm the Examiner’s decision rejecting Claims 1-8 and 11-12 as
unpatentable under 35 U.S.C. § 103(a) over the combined teachings of Donati and
Root and of Claims 9-10 as unpatentable under 35 U.S.C. § 103(a) over the
combined teachings of Donati, Root and Chung.
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