Ex Parte Hickle

Patent Trial and Appeal Board

Jul 31, 2013

11783342 (P.T.A.B. Jul. 31, 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.
11/783,342 04/09/2007 Randall S. Hickle 82021-0027 CON 5325
7590 08/01/2013
Dorsey L. Baker
4603 Eleventh Street
Lubbock, TX 79416
EXAMINER
SCHELL, LAURA C
ART UNIT PAPER NUMBER
3767
MAIL DATE DELIVERY MODE
08/01/2013 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 RANDALL S. HICKLE
____________

Appeal 2012-001233
Application 11/783,342
Technology Center 3700
____________

Before ERIC B. GRIMES, ERICA A. FRANKLIN and
ANNETTE R. REIMERS, Administrative Patent Judges.

REIMERS, Administrative Patent Judge.

DECISION ON APPEAL

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STATEMENT OF THE CASE1
Randall S. Hickle (Appellant) appeals under 35 U.S.C. § 134(a) from
the Examiner’s decision to reject claims 18-20, 22-27, 29 and 31-37. Claims
1-17, 21, 28 and 30 have been canceled. Claims 18, 24, 36 and 37 are before
us for review.2 We have jurisdiction under 35 U.S.C. § 6(b). An oral
hearing was conducted on July 18, 2013. We AFFIRM.
THE INVENTION
Appellant’s invention relates to “automated drug infusion devices.”
Spec. 1, para. [0004]; fig. 1A. Claims 18, 24, 36 and 37 are independent.
Claim 18 is illustrative of the subject matter on appeal and is
reproduced below:
18. A system for safely and efficiently facilitating
sedation and/or pain management of a patient by a non-
anesthetist without general anesthesia during a medical
and/or surgical procedure, said system comprising:
an intravenous drug delivery infusion device
capable of controlling flow of a sedative and/or analgesic
drug to said patient during said procedure,
a monitor for receiving and collecting data
concerning said patient's ventilator condition,
an electronic controller interconnected to said
delivery device to said monitor to regulate an infusion
rate of said drug;

1 Appellant identifies the Real Party in Interest as Scott Laboratories, Inc.
(App. Br. 3).
2 Appellant indicates in the Appeal Brief that “[d]ependent claims 19, 20,
22-23, 25-27, 29, 31-35 are not presented for consideration by the Board for
the reason that they will be deemed allowable and patentable upon any
decision that the independent claims are allowable.” (App. Br. 3) (citation
omitted).

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a pre-packaged disposable kit comprising at least
one disposable item selected from the group of: a drug
cassette, a prepackaged sedative, a prepackaged pain
management drug, infusion tubing, EKG pads, skin
electrodes, IV catheters, and an oro-nasal respiratory set
for interconnection between the patient and the monitor;
and
said disposable kit being packaged and marked to
insure quality, identification and/or safety for use with
said system.

THE EVIDENCE
The Examiner relies on the following references in rejecting the
appealed claims:
Foster US 5,947,284 Sep. 7, 1999
Phoon US 2002/0013640 A1 Jan. 31, 2002
Hanson US 2002/0099334 A1 Jul. 25, 2002
Georgieff US 6,511,453 B2 Jan. 28, 2003

Appellant presents additional evidence in the Declaration filed
under 37 C.F.R. § 1.132 of Randall S. Hickle,3 filed Aug. 25,
2010.4

THE REJECTIONS
The following rejections are before us for review:
1. Claims 18 and 36 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Georgieff and Hanson.
2. Claims 24 and 37 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Georgieff, Hanson, Phoon and Foster.

3 The Declarant, Dr. Randall S. Hickle, is also the inventor in the instant
application.
4 Hereafter the “Hickle Declaration.”

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ANALYSIS
Rejection 1 - Obviousness over Georgieff and Hanson - Claims 18 and 36
Appellant does not present separate arguments for independent claims
18 and 36. App. Br. 10-27. Accordingly, Appellant has argued claims 18
and 36 as a group for purposes of the rejection of those claims under
§ 103(a). Claim 18 is representative of the group and is selected for review,
with claim 36 standing or falling with claim 18. See 37 C.F.R.
§ 41.37(c)(1)(vii)(2011).
The dispute between Appellant and the Examiner is rooted in claim
interpretation. Appellant asserts that claim 18 includes the limitation “by a
non-anesthetist” and that neither Georgieff nor Hanson discloses this
limitation (App. Br. 10-18, 22, 25-26; Reply Br. 3-9, 11). The Examiner
responds that the phrase “by a non-anesthetist” does not limit the claim
(Ans. 20-22), and the combination of Georgieff and Hanson meet the
corresponding limitation(s) in claim 18 (Ans. 5-7; 20-21).
We begin, therefore, by interpreting claim 18. The body of claim 18
requires the claimed system to include an intravenous drug delivery device,
a monitor, an electronic controller interconnected to the delivery device and
monitor and a pre-packaged disposable kit (App. Br. 28, Clms. App’x.). The
body of the claim does not require the system to be operable by any
particular individual. Rather, the claim requires only a system including an
intravenous drug delivery device, a monitor, an electronic controller
interconnected to the delivery device and monitor and a pre-packaged
disposable kit. See In Re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir.
2000)(“broadest reasonable interpretation consistent with the specification”)
(citations omitted).
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The preamble of claim 18 states that the claimed system is “for safely
and efficiently facilitating sedation and/or pain management of a patient by a
non-anesthetist.” (App. Br. 28, Clms. App’x.). This claim language states
the intended use of the claimed system, and Appellant has not provided any
persuasive evidence or sound reasoning for concluding that the intended use
further limits the structural components of the system that are stated in the
body of the claim. That is, Appellant has not explained why a system that
meets the structural limitations in the body of claim 18 could not be used by
a non-anesthetist. Since the preamble language does not limit the scope of
the claim, the preamble is not a claim limitation. See Rowe v. Dror, 112
F.3d 473, 478 (Fed. Cir. 1997) (“[W]here a patentee defines a structurally
complete invention in the claim body and uses the preamble only to state a
purpose or intended use for the invention, the preamble is not a claim
limitation.”) (citations omitted).
Appellant argues, however, that the preamble is limiting because
Appellant, during prosecution, repeatedly expressed his “clear reliance” on
the preamble of the claim for patentability (Reply Br. 4).
This argument is not persuasive. Appellant has not explained how
the preamble limits the structural components (i.e., intravenous drug
delivery device, monitor, electronic controller and pre-packaged disposable
kit) in the system beyond the limitations stated in the body of the claim.
Assertions of “clear reliance” on the preamble as indicating an intended use
do not suffice. See Rowe v. Dror, 112 F.3d at 478.
Claim 18 therefore defines a system comprising an intravenous drug
delivery device, a monitor, an electronic controller interconnected to the
delivery device and monitor and a pre-packaged disposable kit. We agree
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with the Examiner that the combination of Georgieff and Hanson discloses
the structural limitations of claim 18 (Ans. 5-7, 20-22; see also Advisory
Action mailed February 2, 2011, 2). Appellant has not presented any
persuasive arguments or objective evidence to the contrary.
Appellant further contends that Georgieff fails to disclose a patient’s
ventilator/physiological condition (Reply Br. 9-10). Specifically, Appellant
asserts that “Georgieff makes absolutely no disclosure of a flow meter or a
capnometer nor of any other method of measuring volum[e] of air” (id. at 9).
We disagree.
Georgieff discloses that “[a] device for (monitored) analgesia/sedation
can be useful especially in the context of intensive care and after heart
operations. This device comprises a perfuser, optionally a means of
measuring the exhaled xenon, and a pulsoximeter.” Georgieff, col. 7, ll. 42-
46 (emphasis added). Accordingly, we agree with the Examiner that
Georgieff discloses a monitor for a patient’s ventilator/physiological
condition (Ans. 6).
Appellant also contends that “Georgieff makes no disclosure of a
prepackage[d] kit that is properly marked to assist the non-anesthesiologist
in safely and efficiently utilizing a sedation and/or pain management
system” (App. Br. 18).
Appellant’s argument is not persuasive. First, as discussed supra, the
phrase “by a non-anesthetist” states the intended use of the claimed system.
Further, the Examiner relied on Hanson for disclosure of the prepackaged kit
(Ans. 7). Finally, claim 18 requires only that the kit be “marked to insure
quality, identification and/or safety for use with said system” and Appellant
has not shown that Hanson’s kit does not meet this limitation, or that the
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recited marking – printed matter – is functionally related to its substrate. Cf.
In re Gulack, 703 F.2d 1381, 1385 (Fed. Cir. 1983) (“Where the printed
matter is not functionally related to the substrate, the printed matter will not
distinguish the invention from the prior art in terms of patentability.”).
Appellant further argues that Hanson (1) “contains no disclosure of a
kit to be used to enable safety and efficiency in patient sedation and/or
anagelsia by a non-anesthestist [sic]” (App. Br. 16); and (2) “contains not a
shred of disclosure relating to its combination with a sedation system” (App.
Br. 18).
Appellant’s arguments are not persuasive. First, as discussed supra,
the phrase “by a non-anesthetist” states the intended use of the claimed
system and is not a claim limitation. Additionally, we agree with the
Examiner that “the secondary references [cannot] be attacked individually,
as they were used in the rejection in combination with the primary reference
of Georgieff” (Ans. 23). See In re Merck & Co., 800 F.2d 1091, 1097 (Fed.
Cir. 1986) (citing In re Keller, 642 F.2d 413, 425 (CCPA 1981) (one cannot
show nonobviousness by attacking references individually where the
rejections are based on combinations of references). The Examiner has set
forth specific citations to the references relied upon (see Ans. 5-7, 23-24),
and has explained why the skilled artisan would modify Georgieff with
Hanson (see Ans. 7, 23-24). As such, we find that the Examiner has
provided a reason with rational underpinnings to support the conclusion of
obviousness. Appellant has not provided any persuasive evidence of error
regarding the Examiner’s stated reasoning or conclusion of obviousness.
Further, we recognize Appellant’s contentions regarding Georgieff
and an asserted Food and Drug Administration (FDA) non-approval of
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Appellant’s invention (App. Br. 20-21). We are, however, not persuaded.
Considerations about safety are entertained by the FDA, not the Patent and
Trademark Office. See In re Brana, 51 F.3d 1560, 1567 (Fed. Cir. 1995). In
this case, while there could conceivably be public health and safety
considerations that would discourage the use by a non-anesthetist of the
sedation system suggested by Georgieff in view of Hanson, we do not agree
that such considerations come into play when obviousness is at issue and
there is no evidence that the suggested sedation system would not work if
operated by a non-anesthetist. For the foregoing reasons, the prior art
suggests a sedation system; whether such a sedation system would be
approved or marketed to the public is another question unrelated to its
patentability.
Lastly, regarding Appellant’s arguments concerning the level of
ordinary skill in the art (App. Br. 19-20), the Examiner made findings as to
the scope and content of the prior art and differences between the prior art
and the claimed invention under Graham v. John Deere Co., 383 U.S. 1
(1966). Though the Examiner did not make a specific finding regarding the
level of skill in the art, Appellant has not argued that the proposed
modifications were beyond the level of skill in the art, and we consider the
applied prior art (Georgieff and Hanson) to be reflective of the level of skill
in the art. See In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (“The
person of ordinary skill in the art is a hypothetical person who is presumed
to know the relevant prior art.” (citing Custom Accessories, Inc. v. Jeffrey-
Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986)).
Accordingly, for the foregoing reasons, we sustain the Examiner’s
rejection of claim 18 and of claim 36, which falls with claim 18.
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Rejection 2 - Obviousness over Georgieff, Hanson, Phoon, and Foster -
Claims 24 and 37
Regarding the additionally cited references (Phoon and Foster),
Appellant presents arguments similar to those discussed above in reference
to Georgieff and Hanson (i.e., neither reference discloses use by a non-
anesthetist and arguing the references individually (see App. Br. 16, 18-19)).
We are not persuaded by these arguments. Accordingly, we also sustain the
Examiner’s rejection of claims 24 and 37 as unpatentable over Georgieff,
Hanson, Phoon, and Foster.
DECISION
We AFFIRM the decision of the Examiner as to claims 18, 24, 36 and
37.
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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