Ex Parte Swann

Patent Trial and Appeal Board

Oct 25, 2016

12577112 (P.T.A.B. Oct. 25, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/577,112 10/09/2009
131006 7590 10/27/2016
Bayer HealthCare LLC (ESU)
Patent Department
attn: Aseem V. Mehta, U.S. Chief Patent Counsel
2 T.W. Alexander Drive, P.O. Box 12014
Research Triangle Park, NC 27709
Betsy Swann
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.
ESU05002 US 3548
EXAMINER
CARREIRO, CAITLIN ANN
ART UNIT PAPER NUMBER
3772
NOTIFICATION DATE DELIVERY MODE
10/27/2016 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):
uspoccs@bayer.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BETSY SW ANN
Appeal2015-001481
Application 12/577, 112
Technology Center 3700
Before JENNIFER D. BAHR, LINDA E. HORNER, and
BRANDON J. WARNER, Administrative Patent Judges.
HORNER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Betsy Swann (Appellant) seeks our review under 35 U.S.C. § 134 of
the Examiner's decision rejecting claims 20-32, which are all of the pending
claims. We have jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
Appeal2015-001481
Application 12/577, 112
CLAIMED SUBJECT MATTER
Appellant's clairned subject matter relates to "'methods and
apparatuses for endometrial ablation and intrafallopian tube contraceptive
devices." Spec., para. 1. Claims 20 and 25 are independent. Claim 25~
reproduced below, is illustrative of the subject matter on appeaL
25. A sterilization device comprising:
a sheath having a proximal end and a distal end;
a shaft slidably disposable within the sheath; and
an ablation element connected to the shaft to ablate uterine
tissue, the ablation element comprising an electrode array portion
and a pair of non-conductive portions, the ablation element being
expandable to conform to a uterus such that each non-conductive
portion occupies a different comer region of the expanded
ablation element in contact with a different ostium of a pair of
fallopian tubes such that the electrode array portion does not
come into contact with the ostia.
Independent clairn 20 is directed to a method of sterilizing
reproductive tissue, and similarly recites, in pertinent part:
expanding the ablation element to conform to the uterus
with the pair of non-conductive portions occupying a pair of
comer regions of the expanded ablation element adjacent a pair
of ostia of a pair of fallopian tubes such that the electrode array
does not contact the ostia.
EVIDENCE
The Examiner relied upon the following evidence:
Ryan
Tran
Payne
US 2005/0182397 Al Aug. 18, 2005
US 2005/0274384 Al Dec. 15, 2005
US 2008/0154256 Al June 26, 2008
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Application 12/577, 112
REJECTIONS
Appellant appeals from the Final Action, dated November 19, 2013
("Final Act."), which includes the following rejections:
1. Claim 25 under 35 U.S.C. § 103(a) as unpatentable over Payne and
Ryan.
2. Claims 20-24 and 26-32 under 35 U.S.C. § 103(a) as unpatentable
over Payne, Ryan, and Tran.
ANALYSIS
First Ground of Rejection
Independent claim 25 calls for an "'ablation element being expandable
to conform to a uterus such that each non-conductive portion occupies a
different corner region of the expanded ablation element in contact with a
different ostium of a pair of fallopian tubes such that the electrode array
. i · . · · . h I . " i1. ' R 1 . ., (.(__, l . portwn coes not come mto contact wzt _ t'le ostza. r.,_ppea1 _ L _ / , _._aims
App.) (emphasis added).
The Exarniner found that Payne discloses:
[A]n ablation element (RF head 303 in figures lOE and llA)
connected to the shaft (as shown in figures lOE and llA) to
ablate uterine tissue (see page 9 [0115]), the ablation element
comprising an electrode array (on the RF applicator - see page 1
[0007]) and a pair of non-conducting portions (non-conductive
regions 344 as best shown in figure llB) which are each
positioned adjacent a tubal ostium for a fallopian tube (see page
9 [O 115] which discloses that the RF applicator head 303 (which
includes the pair of nonconductive portions 344) is positioned at
a tubal ostium 110).
Final Act 6-7. The Examiner acknowledged that '"Payne does not ...
disclose that the ablation element is expandable to confonn to a uterus with
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Appeal2015-001481
Application 12/577, 112
each non-conductive portion occupying a different comer region of the
expanded ablation element in a different ostium of a pair of fallopian tubes
such that the electrode array does not come into contact with the ostia." Id.
at 7. However, the Examiner found:
Ryan discloses an ablation device 10 which includes a
distendable bladder 102 which is inflated to conform to a body
cavity such as a uterus (page 2 [0029]) whereas shown i.e. in
figures 1-2, at least one resistive element is coupled to the outer
surface of the bladder (116a-c in figures 1-2) but any number of
resistive elements can be used and they could be positioned at
any desired location on the outer surface of the balloon (page 3
[0032]).
Id. (emphasis added). The Examiner determined:
It would have been obvious to one having ordinary skill in the
art, at the time of the invention, to modify the device of Payne so
that the ablation element is expandable to conform to a uterus, as
in Ryan, in order to allow for sufficient contact between the
device and the endometrial lining so that the maximum amount
of coverage is possible (page 1 [0005]). Furthermore, it also
would have been obvious to modifY the device of Payne so that
each non-conductive portion occupies a different corner region
of the expanded ablation element in a different ostium of a pair
of fallopian tubes such that the electrode array is not in contact
with the ostia, as in Ryan, in order to allow for targeted
heating/ablation (page 1 [0005]).
id. at 7----8 (emphasis added).
Appellant argues that the Examiner's proposed modification of
Payne's device so that the electrode array of the expanded ablation element
does not contact the ostia is "contrary to the teaching of P£lJ:.'lL0." and '"is the
result of impennissible hindsight." Appeal Br. 11. In particular, Appe11ant
asserts that "Pavne requires the electrode pairs 340a---340d to be positioned
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Appeal2015-001481
Application 12/577, 112
within the tubal ostium in order to perform its intended function of ablating
the uterine tissue within the tubal osthun 110." Id. (boldface omitted).
According to Appellant, '"Pavne is explicit that the electrodes are placed at
the tubal ostium in order to ablate uterine tissue within the tubal ostimn
1 Hl" Reply Br. 3; see id. at 2 (pointing to paragraph 115 of Payne). For the
reasons that follow, we agree with Appellant that the Examiner's proposed
modification of Payne's device based on the teachings of Ryan is not
supported by adequate reasoning based on rational underpinnings. See KSR
int 'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (quoting In re Kahn, 441
F.3d 977, 988 (Fed. Cir. 2006)).
Payne discloses a device, and coffesponding method of using said
device, for female sterilization that includes "RF applicator head 303 ...
[with] an electrode caffier having one or more bipolar electrodes." Payne,
para. 114. Payne discloses that "RF applicator head 303 is introduced
transcervically into the uterine cavity and positioned at a tubal ostium 110,"
\vherein "[t]ransmitting RF energy through the RF applicator head 303
ablates the uterine tissue 106, 108 and the tissue within the tubal ostium
110!' Id. at 115 (emphasis added). According to Payne, "[f]ollowing the
destmction of the tissue at the tubal ostium 110, the healing response
occludes the tubal ostiurn 110 and the adjacent portion of the fallopian tube
104 resulting in sterilization." Id. Thus, Payne's sterilization device uses
electrodes for targeted ablation of tubal ostium tissue so that scan-ing
occludes the fallopian tube.
Ryan discloses device 100 for ablating a body cavity, such as a uterus,
including distendable bladder 102 "designed such that, when in the inflated
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Appeal2015-001481
Application 12/577, 112
state, ... distendable bladder [102] substantially approximates the interior of
the body cavity." Ryan, para. 29. Device 100 includes '"multiple resistive
elements 116a, 116b, ll6c ... positioned at desired locations about the
outer surface of ... distendable bladder [102]." Id., para. 32. Ryan further
discloses "'that any number of resistive elements could be used, and that they
could be placed at any desired location on the outer surface of the
[ distendable bladder l 02]." Id.
\Ve are persuaded by Appellant that the Examiner has failed to
articulate adequately why one having ordinary skill in the art would have
been Ied to modify the expanded ablation element in the device of the
proposed combination of Payne and Ryan such that the electrodes of the
expanded ablation element do not contact the tubal ostia. Although Ryan
evidences that electrodes could be placed at any desired location on an
expandable ablation device (Ryan, para. 5), this is an insufficient
explanation of a reason to modify Payne's device, which specifically targets
tubal ostia tissue for ablation, such that the electrodes do not contact the
tubal ostia, as called for in claim 25. For these reasons, we do not sustain
the rejection of claim 25 under 35 U.S.C. § 103(a) as unpatentable over
Payne and Ryan.
Second Ground qfRejection
Claims 20-24 and 26-32 are subject to the second ground of rejection
as being unpatentable over Payne, Ryan, and Tran. As noted supra,
independent claim 20, similar to claim 25, calls for expanding the ablation
element such that the electrode arrav does not contact the ostia. Claims
,/
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21-24 depend from claim 20. Claims 26-32 depend frorn independent
claim 25.
The rejection of claims 20----24 and 26---32 relies upon the same
proposed combination of Payne and Ryan that we found deficient in the
analvsis of claim 25 discussed suvra. See Final Act 3---6, 8----10. The
~ L
Examiner did not rely on any disclosure of Tran, nor articulate any
additional reasoning, that would remedy this deficiency. Accordingly, we
do not sustain the rejection of claims 20-24 and 26-32, under 35 U.S.C.
§ 103(a) as unpatentable over Payne, Ryan, and Tran.
DECISION
The decision of the Examiner to reject claims 20-32 is REVERSED.
REVERSED
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