Ex Parte Dubey et al

Patent Trial and Appeal Board

Nov 5, 2012

11544261 (P.T.A.B. Nov. 5, 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.
11/544,261 10/06/2006 Dharmesh Dubey 1133-3CIP2 8513
7590 11/05/2012
Christopher & Weisberg, P.A.
Suite 2040
200 East Las Olas Boulevard
Ft. Lauderdale, FL 33301
EXAMINER
NGUYEN, HUONG Q
ART UNIT PAPER NUMBER
3736
MAIL DATE DELIVERY MODE
11/05/2012 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 PATENT TRIAL AND APPEAL BOARD
____________

Ex parte DHARMESH DUBEY
and TIM BAIRD
____________

Appeal 2010-006901
Application 11/544,261
Technology Center 3700
____________

Before STEFAN STAICOVICI, JAMES P. CALVE, and
SCOTT A. DANIELS, Administrative Patent Judges.

CALVE, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134 from the rejection of claims
1, 3-9, and 11-15. App. Br. 1. Claims 2, 10, and 16-18 have been cancelled.
Id. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
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Application 11/544,261

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CLAIMED SUBJECT MATTER
Claim 1 is illustrative of the claimed subject matter on appeal:
1. A cervimetry device for measuring cervical dilation,
comprising:
an elongate body defining a proximal end, a distal end,
and a longitudinal axis;
a distal pressure sensor at the distal end operable to
measure an axial pressure along the longitudinal axis;
an expandable element coupled to the distal end of the
elongate body;
an array of movable elements disposed about the
expandable element;
an inflation source in communication with the
expandable element; and
a control element for controlling the inflation source and
indicating a cervical dilation measurement, wherein the distal
pressure sensor is in communication with the control element.

REJECTIONS
Claims 1, 4, 8, 9, 14, and 15 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Foltz (US 2005/0055043 A1; pub. Mar. 10, 2005),
Dwyer (US 3,312,222; iss. Apr. 4, 1967), Bonutti (US 6,451,042 B1; iss.
Sep. 17, 2002), and Biehl (US 6,425,899 B1; iss. Jul. 30, 2002).
Claims 3 and 13 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Foltz, Dwyer, Bonutti, and Biehl, further in view of
Varghese (US 2004/0210136 A1; pub. Oct. 21, 2004).
Claims 6, 11, and 12 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Foltz, Dwyer, Bonutti, and Biehl, further in view of
Mansour (US 2005/0049509 A1; pub. Mar. 3, 2005).
Claims 1, 5-8, 11, and 12 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Mansour, Dwyer, Bonutti, and Biehl.
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Claim 13 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Mansour, Dwyer, Bonutti, and Biehl, further in view of Varghese.
ANALYSIS
Claims 1, 4, 8, 9, 14, and 15 as unpatentable over Foltz, Dwyer, Bonutti,
and Biehl
Appellants argue claims 1, 4, 8, 9, 14, and 15 as a group. App. Br. 6-
11. We select claim 1 as representative. See 37 C.F.R. 41.37(c)(1)(vii)
(2011). The Examiner found that Foltz discloses a cervimetry device that
measures cervical dilation and has an elongate body, expandable elements
40, 60 coupled thereto, an inflation source 91, and a control element 90 to
control the inflation source and indicate a dilation measurement. Ans. 3.
The Examiner found that Dwyer uses an array of movable elements 2 for
cervical dilation, and Bonutti teaches that it is well known to dispose such an
array 478 about an expandable element 474 to expand the movable elements.
Ans. 3. The Examiner found that Biehl discloses an obstetrical device that
contacts a fetal head and has pressure sensors 19 that detect the pressure of
the contact surface on the fetal head to prevent injury to a baby’s head. Ans.
4. The Examiner determined that it would have been obvious to modify the
device of Foltz, Dwyer, and Bonutti to include at least one pressure sensor
on a contact portion of the device to prevent injury to a baby’s head from too
much pressure from the contact portion, which would be at the distal end of
the device. Ans. 4, 18. The Examiner reasoned that while Biehl measures
pressure in a different direction than the claimed device, when the teachings
of Biehl are combined with Foltz, Dwyer, and Bonutti, ordinary ingenuity
would dictate that a pressure sensor would be placed at the distal end to
measure axial pressure along the longitudinal axis of the device because
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Dwyer teaches longitudinal movement and contact with the fetal head would
occur at the distal end during such movement. Ans. 18.
Appellants argue that the Examiner has not provided a reasonable
basis to combine a device designed to grasp and pull a fetus’s head (Biehl)
with technology for arthroscopic surgery (Bonutti) and a cup designed to
avoid grasping and pulling a fetus’s head (Dwyer). Reply Br. 8. Appellants
also argue that a skilled artisan would not expect a successful outcome when
combining Biehl, Bonutti, and Dwyer, and the Examiner has failed to
provide any rationale as to why the combination of these devices would be
successful. App. Br. 8-9. These arguments do not persuade us of error in
the Examiner’s findings and determination of obviousness. The Examiner
relied on Foltz to disclose a cervimetry device with a longitudinal axis and
expandable element. The Examiner relied on Dwyer to teach an array of
movable elements disposed circumferentially to promote cervical dilation,
and Bonutti to teach that it is well known to dispose movable elements about
an expandable element 474 to promote expansion of the elements. Ans. 3.
The Examiner determined that it would have been obvious to combine these
teachings with Foltz to improve Foltz by using an array of movable elements
and an expandable element to expand the movable elements more effectively
for use as a cervimetry device. Ans. 3-4. The Examiner combined specific
elements of each device according to their known functions for predictable
results to improve Foltz as a cervimetry device.
Appellants argue that there is no reason to modify Dwyer’s device,
which is a cup that surrounds a baby’s head but does not grasp the baby,
with a pressure sensor from Biehl’s device, which intentionally grasps a
baby’s head, or Bonutti’s device, which is used for dissecting tissue. App.
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Br. 8. Appellants also argue that the modified device would not detect an
axial pressure along a longitudinal axis as claimed because Biehl measures
contact pressure between the contact surface of the forcep blades and the
baby’s head, which is substantially perpendicular to the longitudinal axis.
App. Br. 9-10 (citing fig. 2). Appellants also assert that neither Biehl nor
Dwyer contacts or is intended to contact the top of the fetus’s head where
axial pressure is measured and the Examiner has gleaned this feature from
Appellants’ disclosure. Reply Br. 8. These arguments do not persuade us of
error in the Examiner’s reasons for combining Foltz, Dwyer, and Bonutti as
discussed supra. The Examiner found that a skilled artisan would include
Biehl’s pressure sensor on a distal end of the modified device of Foltz with
Dwyer’s array of elements to measure axial pressure and prevent injury to a
baby’s head during use of the device. This finding is supported by a rational
underpinning in that Dwyer’s device is inserted into the uterus and opened
so that the array of elements 2 forms a cup 1 between the fetal head and
lower segment of the uterus and cervix so traction can be applied to
stimulate uterine contraction and cervical dilatation. Col. 2, ll. 4-11; fig. 5.
A pressure sensor at the distal end of the device would prevent injury to a
fetus’s head from contact or undue pressure when the device is emplaced in
a uterus and used to dilate the cervix. See Ans. 18; Dwyer, fig. 5.
Appellants also argue that Biehl and Bonutti are non-analogous art.
Appellants argue that Biehl discloses forceps that grasp a fetus’s head during
childbirth and would not have logically commended itself to an inventor of a
device to measure cervical dilation before childbirth because grasping a
fetus’s head is the opposite of the present invention, which is designed to be
minimally invasive and sensitive to the fetus’s body, in particular the skull.
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App. Br. 7. Appellants also argue that Biehl is from a different field of
endeavor even though both devices are inserted into the female reproductive
region because they are used for very different purposes. Reply Br. 6-7. We
agree with the Examiner that Biehl is reasonably pertinent to the problem of
designing a medical device for measuring and performing cervical dilation
without injury to a fetus.1 Ans. 16; see Spec. 5, para. [0029]. Appellants use
a distal pressure sensor 46 to provide feedback to a physician to aid in the
proper axial positioning of their device by detecting contact with the cervix
and head 56 of a baby. Spec. 7-8, paras. [0033, 0041]. Proper positioning
also prevents damage to the uterus when the device is used to dilate a cervix.
Spec. 13, para. [0045]; fig. 8. Biehl measures pressure applied to a baby’s
head by forcep blades 8, 9 and warns a physician when a maximum pressure
has been reached. Col. 4, ll. 3-19 and 38-50. Appellants and Biehl are both
concerned with sensing pressure of an obstetric device on a fetus’s head to
ensure that the device is properly positioned and to prevent injury to a fetus
through improper use and positioning of the devices.
Appellants argue that Bonutti is non-analogous art because Appellants
are concerned with effecting cervical dilation without damaging the fetus,
whereas Bonutti is concerned with “moving tissue” for arthroscopic surgery,
which is a different problem solving area. Reply Br. 7; App. Br. 7-8. We
agree with the Examiner that Bonutti is reasonably pertinent to the problem

1 Although the Examiner characterizes this finding as relating to Appellants’
field of endeavor, the finding actually pertains to the problem confronted by
Appellants of inserting a medical device into the female reproductive region
while preventing damage to a fetus’s head. Ans. 16 (para. 36). This basis
becomes more apparent in the next paragraph where the Examiner discusses
Bonutti as being analogous art and refers to cervical dilation as Appellants’
field of endeavor. Ans. 16 (para. 37).
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of designing a medical device that measures and performs a cervical dilation
addressed by Appellants. Ans. 16. Appellants use an expandable element
38 to expand an array of movable elements 24 to measure cervical dilation
(para. [0043) and to provide a safe, uniform cervical dilation where a desired
dilated condition has not occurred (para. [0045]). Bonutti uses an inflatable
bladder 474 to move an array of expanding fingers 478 radially outwardly to
move tissue as desired for arthroscopic surgery without damaging the moved
tissue. Col. 15, ll. 7-16; col. 2, ll. 23-26; figs. 38, 39. Both devices use an
expandable array to move tissue so that other medical procedures may occur.
We sustain the rejection of claims 1, 4, 8, 9, 14, and 15.
Claims 3 and 13 as unpatentable over Foltz, Dwyer, Bonutti, Biehl, and
Varghese
Independent claim 13 recites a cervimetry device with similar features
as claim 1, including at least one pressure sensor coupled to at least one of
the array of movable elements. The Examiner relied on Varghese to disclose
this feature and Foltz, Dwyer, Bonutti, and Biehl to disclose the other claim
elements including a distal pressure sensor. Ans. 8-10. Appellants argue
that Foltz, Dwyer, Bonutti, Biehl, and Varghese do not disclose a distal
pressure sensor that measures axial pressure along a longitudinal axis. App.
Br. 11-12. This argument is not persuasive for the reasons discussed supra
for claim 1. We sustain the rejection of claims 3 and 13.
Claims 6, 11, and 12 as unpatentable over Foltz, Dwyer, Bonutti, Biehl, and
Mansour
Appellants argue that claims 6, 11, and 12 are allowable because they
depend from claim 1. App. Br. 12. Because we sustain the rejection of
claim 1, this argument is not persuasive and we sustain the rejection of
claims 6, 11, and 12.
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Claims 1, 5-8, 11, and 12 as unpatentable over Mansour, Dwyer, Bonutti,
and Biehl
Appellants argue claims 1, 5-8, 11, and 12 as a group. App. Br. 12-
13. We select claim 1 as representative. The Examiner found that Mansour
discloses a cervimetry device with an elongated body, expandable element,
and control but lacks an array of movable elements. Ans. 11. The Examiner
relied on Dwyer to disclose an array of movable elements for dilation and
Bonutti to disclose an array of movable elements 478 disposed about an
expandable element 474. Ans. 11. The Examiner found that Biehl teaches
an obstetrical device with pressure sensors 19 to detect the pressure between
the contact surface and fetal head to prevent injury to a baby’s head. Ans.
12. The Examiner determined that it would have been obvious to include a
pressure sensor as taught by Biehl on a distal contact end of the device of
Mansour, Dwyer, and Bonutti to prevent injury to a baby’s head from too
much pressure and to enable control of the device in response to a measured
contact pressure between the device and fetal head. Ans. 12.
Appellants argue that Dwyer, Bonutti, and Biehl fail to disclose a
distal pressure sensor for the reasons discussed supra and Mansour fails to
disclose this feature. App. Br. 12. We agree with the Examiner that this
feature is obvious for the reasons set forth in the Answer at page 12. We
sustain the rejection of claims 1, 5-8, 11, and 12.
Claim 13 as unpatentable over Mansour, Dwyer, Bonutti, Biehl, and
Varghese
Appellants argue that independent claim 13 recites “a distal pressure
sensor . . . operable to measure an axial pressure along the longitudinal axis”
and Mansour, Dwyer, Bonutti, Biehl, and Varghese all fail to disclose this
feature. App. Br. 13. We agree with the Examiner that it would have been
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obvious to modify the device of Mansour, Dwyer, Bonutti, and Varghese
with the teachings of Biehl to include at least one pressure sensor on a distal
end of the contact portion of the device where the device contacts a fetal
head to measure an axial pressure along the longitudinal axis of the device
and effectively prevent injury to the baby’s head from too much pressure
from contact. Ans. 15. We sustain the rejection of claim 13.
DECISION
We AFFIRM the rejection of claims 1, 3-9, and 11-15.
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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