Ex Parte Vining

Patent Trial and Appeal Board

Apr 30, 2018

14459365 (P.T.A.B. Apr. 30, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/459,365 08/14/2014
110 7590 05/01/2018
DANN, DORFMAN, HERRELL & SKILLMAN
1601 MARKET STREET
SUITE 2400
PHILADELPHIA, PA 19103-2307
David J. Vining
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
4803-P04440US2 3866
EXAMINER
ABOUELELA, MAY A
ART UNIT PAPER NUMBER
3736
MAILDATE DELIVERY MODE
05/01/2018 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 DAVID J. VINING
Appeal2017-003666 1
Application 14/459,365
Technology Center 3700
Before FRANCISCO C. PRATS, JOHN G. NEW, and TA WEN CHANG,
Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to apparatuses
for insufflating a patient's colon to allow scanning. The Examiner rejected
the claims for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b)(l).
We reverse.
1 Appellant states that the "real parties in interest in this appeal is University
of Maryland, Baltimore, the Assignee for the above-referenced patent
application, and Bracco Diagnostics, Inc., a Licensee of the above-
referenced patent application." Appeal Br. 1.
Appeal2017-003666
Application 14/459,365
STATEMENT OF THE CASE
The Specification explains that performing a colonoscopy involves
insufflating the patient's colon with gas, and then scanning the colon, after
which, "image analysis is performed by a physician and/or computer-aided
diagnosis to diagnose polyps, cancer or other abnormalities in the bowel."
Spec. i-f 3. The Specification explains further that improperly insufflating the
colon "may produce misleading images and errors in diagnosis because of
the potential of collapsed bowel segments mimicking or masking true
lesions." Id. i-f 5.
To address that issue, the Specification discloses an apparatus that
ensures proper insufflation by determining that the insufflating gas is within
predetermined ranges of pressure and volume. Id. i-fi-111-12.
Claim 1 illustrates the appealed subject matter and reads as follows:
1. An apparatus configured to prepare a patient's colon for
insufflation and scanning, the apparatus comprising:
a pressure transducer configured to detect a pressure
level of gas within a patient's colon;
a flow meter configured to detect a volume level of gas
delivered to the patient's colon;
circuitry configured to monitor a period of time over
which the pressure level is detected and maintained within a
predetermined range of pressures;
a processor configured to receive an indication of the
pressure level detected by the pressure transducer, an indication
of the period of time over which the pressure level is detected,
and an indication of the volume level detected by the flow
meter, wherein the processor is further configured to determine
whether the pressure level is within the predetermined range of
pressures for a predetermined period of time and whether the
volume level is within a predetermined range of volumes; and
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Application 14/459,365
a signaling unit configured to provide an output
indicating that a scan is valid in an instance in which the
pressure level is determined to be within the predetermined
range of pressures for the predetermined period of time and the
volume is determined to be within the predetermined range of
volumes.
Appeal Br. 14.
The following rejections are before us for review:
(1) Claims 1, 2, 4, 6-8, 10, 12, 14--18, and 20, under 35 U.S.C.
§ 103(a) as being unpatentable over Kraft-Kivikoski2 and Sampson3 (Final
Act. 2-6); and
(2) Claim 9, under 35 U.S.C. § 103(a) as being unpatentable over
Kraft-Kivikoski, Sampson, and Kaufman4 (Final Act. 6-7).
DISCUSSION
As stated inin re Oetiker, 977F.2d1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability ....
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), although the
Supreme Court emphasized "an expansive and flexible approach" to the
obviousness question, id. at 415, the Court also reaffirmed the importance of
determining "whether there was an apparent reason to combine the known
2 US 6,402, 714 B 1 (issued June 11, 2002).
3 US 6,554,780 Bl (issued Apr. 29, 2003).
4 US 2002/0045153 Al (published Apr. 18, 2002).
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Application 14/459,365
elements in the fashion claimed by the patent at issue." Id. at 418 (emphasis
added).
Ultimately, therefore, "[i]n determining whether obviousness is
established by combining the teachings of the prior art, the test is what the
combined teachings of the references would have suggested to those of
ordinary skill in the art." In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir.
1995) (internal quotations omitted).
In the present case, having carefully considered the arguments and
evidence advanced by Appellant and the Examiner, Appellant persuades us
that the Examiner has not shown by a preponderance of the evidence that the
cited references would have rendered obvious the subject matter recited in
Appellant's independent claims. In particular, we are not persuaded that the
Examiner has explained adequately why the combination of Kraft-Kivikoski
and Sampson would have suggested, to an ordinary artisan, apparatuses and
processes having all of the features and steps required by Appellant's
independent claims 1, 10, and 18. More particularly, we are not persuaded
that the Examiner has explained adequately why the cited references would
have suggested using the measured total volume of insufflated gas as an
indication of whether a colon scan was valid, or as an indication as to
whether the insufflating gas should be vented.
Appellant's claim 1, as seen above, recites an apparatus configured to
determine not only whether the pressure of the gas delivered to a patient's
colon has remained within a predetermined pressure range during a
predetermined period of time, but also whether the volume of gas delivered
to the colon is within a predetermined range. Appeal Br. 14.
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Application 14/459,365
Independent claim 10, similarly, recites a process which includes not
only the step of determining whether the pressure of the gas delivered to a
patient's colon has remained within a predetermined pressure range during a
predetermined period of time, but also whether the volume of gas delivered
to the colon is within a predetermined range. Id. at 15-16.
Independent claim 18 recites an apparatus that includes an automated
pressure relief valve which is configured to be actuated to vent a patient's
colon when the volume of insufflated gas exceeds a predetermined volume
threshold. Id. at 17.
Turning to the prior art, Kraft-Kivikoski describes methods for
insufflating air into a body cavity for performing surgical procedures. Kraft-
Kivikoski, 1:6-21. Kraft-Kivikoski discloses that the accuracy of the
reading of intracavity pressure may be improved by intermittently delivering
insufflating gas into the patient, and optimizing the duration of the
interruption periods during which no gas is introduced. See, e.g., id. at 8:66-
9:5 ("Once the apparatus detects [a potential gas obstruction], it increases,
for example, doubles the interruption phase, so that a volume of pressurized
[gas] accumulated upstream from the needle substantially dissipates
therethrough. Only at the end of this increased interruption phase a
measurement of the intracavity pressure is made.").
As the Examiner found, and as required by Appellant's claims 1, 10,
and 18, Kraft-Kivikoski discloses that its device includes a pressure
transducer configured to measure the intracavity (i.e., intra-colon) gas
pressure. Id. at 7:61---65 ("A pressure gauge 27 indicates the insulation
pressure upstream of the Veress needle 12 and, at the times when the flow
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Application 14/459,365
indicator 23 shows a zero flow rate (also, see FIG. 8), the pressure indicated
by the gauge 27 corresponds to the intracavity pressure.").
As the Examiner found, and as required by Appellant's claims 1, 10,
and 18, Kraft-Kivikoski discloses that its device also includes a flow meter
that determines the total amount of gas that has been insufflated into the
patient. Id. at 7:44--47 (describing a "flow transducer 22 that provides an
electronic signal proportional to flows of the pressurized fluid varying
between 0 and 40 Standard Liters Per Minute"); see also id. at 7:55-57
("[T]he total flow of pressurized fluid is determined and indicated on an
electric indicator 25 having a scale graduated in liters.").
Kraft-Kivikoski explains that "[k]nowledge of the total flow of fluid is
necessary since if the insufflation apparatus or the body cavity allows
pressurized fluid to leak, the measurement of the rate of flow cannot be
indicative of the patient's condition." Id. at 7:57---61.
As the Examiner found, and as required by Appellant's claim 18,
Kraft-Kivikoski's device includes "a relief valve 24 relieving pressures
above 55 mmHg." Id. at 7:48--49.
As the Examiner found, Kraft-Kivikoski does not describe
determining that, as an indication of a valid scan, the pressure and volume of
insufflated gas remain within predetermined ranges as recited in Appellant's
claims 1 and 10. Nor does Kraft-Kivikoski describe actuating its pressure
relief valve in response to a determination that the volume of insufflated gas
has exceeded a predetermined threshold, as recited in Appellant's claim 18.
Sampson, however, discloses that when performing surgical
procedures involving gas insufflation, it is important to determine whether
the insufflated body cavity has a perforation. Sampson, 1: 17--43.
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As the Examiner found, Sampson discloses that the presence or
absence of a perforation in a body cavity (and thereby a determination
whether an associated surgical procedure is acceptable) can be ascertained
by determining whether the pressure of insufflated gas remains within a
predetermined range over time, as recited in Appellant's claims 1, 10, and
18, and discloses outputting the result of that determination, as recited in
Appellant's claims 1 and 10:
Microprocessor 34 ... determines if pressure in the body cavity
BC has failed to achieve a predetermined threshold (indicating
a perforation in the body cavity) or if it has and maintained the
threshold for a predetermined time period (indicating that the
body cavity has no perforation). In this capacity, the
microprocessor or programmable logic device serves as a
feedback means that activates a notification signal to alert a
user if the pressure monitored by the pressure sensor fails to
rise and remain above a predetermined level during a
predetermined amount of time. The micro[]processor may
initiate various forms of notification signals, such as visual or
auditory signals.
Id. at 5:27--40.
However, even assuming for the sake of argument that an ordinary
artisan would have been motivated to modify Kraft-Kivikoski's devices and
methods to incorporate Sampson's pressure-based signaling to verify the
presence or absence of perforations when performing an insufflation
procedure, Appellant persuades us that the Examiner has not explained
sufficiently why the cited references suggest also using the total volume of
delivered gas as an indication of a valid scan, or as a trigger for actuating the
pressure relief valve, as Appellant's claims require.
In response to Appellant's arguments in that regard, the Examiner
cites Sampson's disclosure of a "flow control orifice 80, positioned
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Application 14/459,365
downstream of [pressure] regulator 78, [which] limits flow in [gas] line 14 to
100 +/-10 sec/min (standard cc/min)." Sampson, 5:7-9. Based on this
disclosure, the Examiner reasons:
Since Sampson's invention teaches performing a body cavity
assessment (20, Col.2, lines 34-42, as best seen in Fig. I and
Fig.3-4) to detect body cavity perforation, where the body
cavity assessment includes a pressure test, as explained in
(Col.6, line 40 to Col.7, line 15). And also Sampson's
invention teaches orifice 80 is maintaining/limiting flow in line
14 to 100 +/-10 sec/min (Col.5, lines 7-9, as best seen in Fig.3)
during the body cavity assessment (Col.4, line 65-Col.5, line 8),
so under the broadest reasonable interpretation the body cavity
assessment taught by Sampson's invention depends on both
volume and pressure.
Ans. 4.
We are not persuaded. Rather, we agree with Appellant that
Sampson's disclosure of a passive device (flow control orifice 80) that limits
the insufflating gas to a particular flow rate is not a description of a flow
meter that determines whether the volume of insufflated gas is within a
predetermined range, as required by each of Appellant's independent claims
1, 10, and 18. Stated differently, that Sampson's invention, based on its
teaching of a passive flow control device, might "depend[] on both volume
and pressure" (Ans. 4), does not equate to a positive teaching in the
reference of a flow meter that determines whether the volume of insufflated
gas is within a predetermined range, as Appellant's claims require.
We acknowledge, as noted above, that Kraft-Kivikoski teaches the
importance of a flow meter that measures the total volume of gas insufflated
during a procedure. Kraft-Kivikoski, 7:55---61. The Examiner, however,
does not explain why an ordinary artisan would have modified Sampson's
device to use total volume, in addition to intracavity pressure, as an
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indication of the presence of perforations in an insufflated body cavity. In
the absence of a sufficient evidence-based explanation in that regard, we
agree with Appellant that the Examiner's rejection of independent claims 1,
10, and 18 cannot be sustained. Accordingly, we reverse the Examiner's
rejection of independent claims 1, 10, and 18, and their dependent claims,
over Kraft-Kivikoski and Sampson.
As to the Examiner's other rejection, the Examiner cited Kaufman
only as evidence that the features in dependent claim 9 would have been an
obvious variation of the apparatus suggested by the combination of Kraft-
Kivikoski and Sampson, recited in independent claim 1. Final Act. 6-7.
Because the Examiner does not explain, therefore, how Kaufman remedies
the deficiencies, discussed above, of Kraft-Kivikoski and Sampson as to
claim 1, we reverse the Examiner's rejection of claim 9 as well.
SUMMARY
For the reasons discussed, we reverse both of the Examiner's
obviousness rejections.
REVERSED
9