Ex Parte Stone et al

Patent Trial and Appeal Board

May 1, 2018

13764911 (P.T.A.B. May. 1, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/764,911 02/12/2013
71996 7590 05/03/2018
SHUMAKER & SIEFFERT, P.A
1625 RADIO DRIVE, SUITE 100
WOODBURY, MN 55125
FIRST NAMED INVENTOR
Richard T. Stone
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.
P0041356.USU2 1024
EXAMINER
CERIONI, DANIEL LEE
ART UNIT PAPER NUMBER
3736
NOTIFICATION DATE DELIVERY MODE
05/03/2018 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
pairdocketing@ssiplaw.com
medtronic _neuro _ docketing@cardinal-ip .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RICHARDT. STONE and KEITH A MIESEL 1
Appeal2017-002188
Application 13/764,911
Technology Center 3700
Before ERIC B. GRIMES, JEFFREY N. FRED MAN, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a system
for determining the oscillation frequency of the bladder in order, for
example, to treat urinary tract dysfunction. The claims have been rejected as
obvious and as directed to patent-ineligible subject matter. We have
jurisdiction under 35 U.S.C. § 6(b ).
We reverse.
1 Appellants identify the Real Party in Interest as Medtronic plc. Appeal Br. 3.
Appeal2017-002188
Application 13/764,911
STATEMENT OF THE CASE
The Specification states that "[ s Jome patients suffering from injury or
disease that affects bladder function may not be able to void or have reduced
levels of sensation when the bladder is full." Spec. 1: 19--20. The
Specification discloses that
[a] bladder fullness level of a patient may be indicated by an
oscillation frequency of the bladder of the patient. The bladder
may mechanically oscillate in response to the occurrence of
non-micturition contractions of the bladder, which are
contractions not associated with urine release. The frequency at
which the bladder oscillates, e.g., following a non-micturition
contraction, may be correlated to the bladder fullness level. It
is believed that the oscillation frequency of the bladder
decreases with bladder fullness.
Id. at 1 :24--29.
Claims 1-11, 23-27, 33--45, and 58---63 are on appeal. Claim 1 is
illustrative and reads as follows:
Claim 1: A system comprising:
a sensor configured to generate a signal indicative of mechanical
oscillation of a bladder of a patient; and
a processor configured to receive the signal from the sensor,
determine an oscillation frequency of the bladder based on the signal, and
take a responsive action based on the oscillation frequency.
Claims 23, 33, and 58 are also independent. Claim 33 is similar to
claim 1 but requires the processor to be configured to "determine, based on
the oscillation frequency of the bladder, a function that indicates the change
in volume of the bladder of the patient per unit time, and determine a current
bladder volume based on the function," rather than "take a responsive action
based on the oscillation frequency," as recited in claim 1. Claim 23 is
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similar to claim 1 but is phrased in means-plus-function format. Claim 5 8 is
also phrased in means-plus-function format and requires means for both
determining a bladder volume and taking a responsive action.
The claims stand rejected as follows:
Claims 1-11, 23-27, 33--45, and 58---63 under 35 U.S.C. § 101 as
"being directed to or encompassing a human organism" (Ans. 2);
Claims 1-11, 23-27, 33, 35-38, 40--45, 58, and 60---63 under 35
U.S.C. § I03(a) as obvious based on Gerber2 and Kantorovich3 (Ans. 27);
and
Claims 34, 39, and 59 under 35 U.S.C. § I03(a) as obvious based on
Gerber, Kantorovich, and Simon4 (Ans. 45).
I
The Examiner has rejected all of the claims on appeal under 35 U.S.C.
§ 101 as "being directed to or encompassing a human organism." Ans. 2.
The Examiner reasons, for example, that
[ f]or claim 1, "a sensor configured to generate a signal
indicative of mechanical oscillation of a bladder of a patient" is
broad enough to encompass the human finger or hand and "a
processor configured to receive the signal from the sensor,
determine an oscillation frequency of the bladder based on the
signal, and take a responsive action based on the oscillation
frequency" is broad enough to encompass the human brain.
Applicants' specification is consistent with such interpretations
because Applicants' specification indicates that the claimed
2 US 2007/0027494 Al, Feb. 1, 2007.
3 US 2007/0123774 Al, May 31, 2007.
4 US 2012/0101326 Al, Apr. 26, 2012.
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Application 13/764,911
sensor may, for example, be a pressure sensor and does not give
an explicit structure to the processor.
Id. at 2-3. The Examiner relies on similar reasoning with respect to the
other claims on appeal. See id. at 3-7.
Appellants argue, with respect to claim 1, that
the Examiner has not shown that: (1) a human finger or hand
may detect mechanical oscillation of a bladder, such that the
human finger or hand is configured to generate a signal
indicative of the mechanical oscillation of the bladder; or (2) a
human brain may be able to receive such a signal and determine
an oscillation frequency from such a signal.
Appeal Br. 13. With respect to the recited processor, Appellants also argue
that "the Examiner's statement that Appellant's specification 'does not give
explicit structure to the processor' is incorrect," and point to the
Specification's ,r 7 5 as describing various types of mechanical processors.
Id. (footnote omitted). Appellants rely on the same argument with respect to
independent claim 33. Id. at 20-21.
With regard to the means-plus-function claims, Appellants argue that
the Examiner has not shown a human organism to be a
"corresponding structure ... described in the specification [ or
an] equivalent[] thereof." Thus, even if a person of ordinary
skill in the art would understand that a processor "may also
include something else," as asserted by the Examiner, the
Examiner has not shown that the claims interpreted under 3 5
U.S.C. § 112, sixth paragraph read on a human organism when
properly interpreted.
Id. at 18 (footnote omitted, alterations in original). See also id. at 27 (same
argument relied on with respect to independent claim 58).
We agree with Appellants that the Examiner has not shown that the
claims read on a human being. All of the independent claims require either a
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"a sensor configured to generate a signal indicative of mechanical oscillation
of a bladder of a patient" ( claims 1 and 33) or "means for receiving, from a
sensor, a signal indicative of mechanical oscillations of a bladder of a
patient" ( claims 23 and 5 8).
The Specification states that a sensor can be implanted in a patient to
generate a signal indicative ofbladder oscillation frequency. Spec. 2:1-2.
The Specification states that "[s]ensor 12 may be implanted at any suitable
location in patient 16 and relatively close to bladder 14, e.g., such that as
bladder 14 moves during the mechanical oscillations, sensor 12 itself or a
sensing element of sensor 12 moves or so that sensor 12 may sense an
electrical parameter of patient 16 that changes as a function of the
mechanical oscillations." Id. at 8:23-26. The Specification states that
"[s]ensor 12 may include, for example, an acoustic or pressure sensor, a
flexible printed circuit comprising pressure sensitive ink, a piezoresistor, a
piezoelectric crystal, a capacitive sensor, a load cell, a force sensor, a
displacement sensor or another type of analog resistance or voltage based
sensor." Id. at 8:19-22.
The Examiner has not pointed to any description in the Specification,
or evidence from any other source, to support the position (Ans. 51) that the
function of the sensor recited in the claims on appeal could be carried out by
a human being placing their hand or finger on an area above the bladder in
order to sense the oscillation frequency of the bladder. Rejections must be
supported by a preponderance of the evidence of record. See In re Oetiker,
977 F.2d 1443, 1445 (Fed. Cir. 1992): "[T]he examiner bears the initial
burden, on review of the prior art or on any other ground, of presenting a
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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."
We reverse the rejection under 35 U.S.C. § 101 because it is not
supported by a preponderance of the evidence of record.
II
The Examiner has rejected claims 1-11, 23-27, 33, 35-38, 40-45, 58,
and 60-63 as obvious based on Gerber and Kantorovich, and has rejected
claims 34, 39, and 59 as obvious based on Gerber, Kantorovich, and Simon.
The same issue is dispositive for both rejections.
With respect to claim 1, the Examiner finds that Gerber discloses "a
sensor ... configured to generate a signal indicative of distance between the
sensor and the opposite wall of a bladder of a patient." Ans. 27. The
Examiner finds that Gerber also discloses a processor configured to receive
the sensor's signal, determine the distance between the sensor and the
opposite bladder wall, and take responsive action based on the distance. Id.
The Examiner finds that Gerber does not disclose a sensor that
indicates bladder oscillation frequency or a processor that determines
bladder oscillation frequency and takes responsive action based on it. Id.
The Examiner finds, however, that "Kantorovich teaches measuring the
distance from bladder monitoring device (30) to a back bladder wall (70) to
track oscillations in the wall position and/or thickness." Id.
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The Examiner concludes that it would have been obvious
to modify Gerber such that the signal is indicative of
mechanical oscillation of a bladder of a patient and that the
processor is configured to determine an oscillation frequency of
the bladder based on the signal, and take a responsive action
based on the oscillation frequency ... because Kantorivich [sic]
teaches that determining distance to a bladder wall can be used
to track oscillations of the bladder based on the wall position.
A skilled artisan would have been motivated to make such a
modification for the obvious advantage of determining whether
there was an interruption of a urination event (see para [0227]
of Kantorivich ).
Id. at 28. The Examiner relies on similar findings and reasoning with
respect to the other independent claims. See id. at 34--35, 39-40, 43--44.
With respect to claim 1, Appellants argue, among other things, that
[t]he Examiner has not shown that a person having ordinary
skill in the art would have understood Kantorovich to have
described a nexus between a bladder oscillation frequency and
"an interruption of a urination event." Thus, the Examiner has
not shown that modifying Gerber's device in the manner
proposed by the Examiner would have resulted in Gerber's
device "determining whether there was an interruption of a
urination event" based on a bladder oscillation frequency.
Appeal Br. 31-32.
We agree with Appellants that the Examiner has not provided
adequate reasoning, supported by the evidence, to conclude that it would
have been obvious to combine Gerber and Kantorovich in the manner
claimed.
Gerber discloses "a sensing device that is implantable to sense bladder
conditions, as well as a neurostimulation system and method that make use
of such a sensor for alleviation of urinary incontinence." Gerber ,r 5. "The
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internal bladder condition may be indicative of bladder filling, expansion or
contraction, or pH, and may be used to control electrical neurostimulation."
Id. "Bladder conditions may be sensed using any of a variety of sensors,
such as sensors that measure impedance, pH, pressure, distance or other
parameters." Id. ,r 20.
In the embodiment cited by the Examiner, Gerber describes a sensor
that uses ultrasound to determine the distance between a transceiver on the
end of the sensor and the opposite bladder wall. Id. ,r,r 57-58. "The distance
indicates the size of bladder 14, and hence the amount of stretching of the
bladder due to the present urine fill level." Id. ,r 58.
As bladder 14 fills with urine, the entire bladder will distend to
increase the size of the bladder. Therefore, the distance
measured by transceiver 46 is indicative of an expanding or
contracting bladder. If bladder 14 begins to reduce in size
without patient 12 requesting a voiding event, stimulator 18
may increase stimulation to the urinary sphincter or pelvic floor
muscles to stop the leaking of urine.
Id. ,I 59.
Kantorovich discloses "measuring one or more parameters of a human
urinary bladder using a frequency modulated ultrasonic signal." Kantorovich
,r 16. The detected signals can be "used to determine a distance between near
and far bladder walls. Optionally, this distance is used to estimate bladder
fill level and/or other bladder parameters .... [such as] bladder wall thickness
or bladder wall compliance." Id. ,r 17.
Kantorovich states that its Figure 9 A "is a graph 900 showing
measurement results taken in real time during urination." Id. ,r 226. The
graph includes lines indicating the distances from a device to each of the
forward and back bladder walls, and a line indicating the inter-wall distance.
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Id. Kantorovich states that a "reference 912 indicates oscillations in the
bladder geometry, possibly indicating post-urination muscle relaxation." Id.
Kantorovich states that its Figure 9B "is a graph 920 showing
measurements associated with a partial urination event," and includes lines
indicating the same distances as in Figure 9A. Id. ,r 227. In Figure 9B, a
"series of oscillations 924 possibly indicate (forced) relaxation of the
bladder as a result of interruption of the urination event." Id.
Kantorovich states that its device can be "used for uses other than
preventing or assisting urination." Id. ,r 244. Among those possible uses,
"oscillations in wall thickness and/or wall positions are tracked." Id. ,r 246.
In one embodiment, a "tracked parameter is compared to a template, for
example a template derived from a same user or a different user or group of
users. Different templates or different frequencies, number of oscillations
and/or amplitudes may indicate diseased or normal conditions." Id. ,r 247.
Thus, Gerber describes a system for treating incontinence that tracks
the distance between the walls of the bladder to determine the urine fill
level, and can take action in response to the sensed size (i.e., fill level).
Kantorovich discloses a similar system, and discloses that oscillations can be
caused either by post-urination muscle relaxation or by forced relaxation of
the bladder because of interrupted urination. Kantorovich also discloses that
its device can be used to track oscillations in wall positions, among other
things, and that frequencies of oscillations that are different from a template
might indicate "diseased or normal conditions." Kantorovich ,r 24 7.
The Examiner, however, has not pointed to any disclosure in
Kantorovich that would indicate to a person of ordinary skill in the art that
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sensing the frequency of mechanical oscillations of the bladder wall, as
recited in claim 1, would be useful in Gerber's system. The passages of
Kantorovich cited by the Examiner do not indicate, for example, that the
frequency of bladder wall oscillation is a useful indicator of the urine fill
level of the bladder, or provide any other basis for concluding that
oscillation frequency would be a useful parameter to track in Gerber's
system.
We therefore agree with Appellants that the Examiner has not
established a nexus between Gerber's system and Kantorovich's disclosure
of measuring bladder wall oscillation. We reverse the rejection of claims 1-
11, 23-27, 33, 35-38, 40-45, 58, and 60-63 as obvious based on Gerber and
Kantorovich.
With regard to claims 34, 39, and 59, the Examiner relies on Simon
only for the additional limitation of the dependent claims. Ans. 45--49. We
therefore reverse the rejection of claims 34, 39, and 59 as obvious based on
Gerber, Kantorovich, and Simon for the same reason discussed above with
respect to claim 1.
SUMMARY
We reverse all of the rejections on appeal.
REVERSED
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