Ex Parte Govari

Patent Trial and Appeal Board

Mar 29, 2017

12636064 (P.T.A.B. Mar. 29, 2017)

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.
12/636,064 12/11/2009 Assaf Govari BI05227USNP 1552
25570 7590 03/31/2017
Roberts Mlotkowski Safran Cole & Calderon, P.C.
7918 Jones Branch Drive
Suite 500
McLean, VA 22102
EXAMINER
RAM, JOCELYN D
ART UNIT PAPER NUMBER
3739
NOTIFICATION DATE DELIVERY MODE
03/31/2017 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):
lgallaugher@rmsc2.com
docketing@rmsc2.com
dbeltran @ rmsc2. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ASSAF GOVARI
Appeal 2015-007849
Application 12/636,064
Technology Center 3700
Before: EDWARD A. BROWN, LEE L. STEPINA, and
SEAN P. O’HANLON, Administrative Patent Judges.
BROWN, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Assaf Govari (Appellant)1 appeals under 35 U.S.C. § 134(a) from the
Examiner’s decision rejecting claims 1—6.2 We have jurisdiction under 35
U.S.C. § 6(b).
We REVERSE.
1 Biosense Webster (Israel) Ltd. is identified as the real party in interest.
Appeal Br. 1.
2 Claim 7 is cancelled, and claims 8—21 are withdrawn from consideration.
Appeal Br. 9—12 (Claims App.).
Appeal 2015-007849
Application 12/636,064
INVENTION
Claim 1 is representative of the claimed subject matter, and reads:
1. A medical device, comprising:
an insertion tube, having a longitudinal axis and having a
distal end adapted and configured for insertion through a body
passage into a cavity within a body of a patient without use of
any active steering mechanism therein;
an electrode, which is located on the distal end of the
insertion tube and is configured to contact tissue in the cavity;
and
a resilient member pre-formed in a curved shape, the
curved shape consisting of a single arcuate segment, which is
contained only within the distal end of the insertion tube and is
configured, when unconstrained, to cause the distal end to bend
away from the longitudinal axis in the curved shape and to
straighten the curved shape of the distal end of the insertion tube
toward the longitudinal axis when subjected to an inward radial
force, wherein the resilient member is configured to buckle when
the radial force exceeds a predetermined threshold to prevent the
puncturing of tissue due to excessive pressure.
Appeal Br. 8 (Claims App.).
REJECTIONS
Claims 1, 2, and 6 are rejected under 35 U.S.C. § 102(b) as anticipated
by Belhe (US 7,122,034 B2, issued Oct. 17, 2006).
Claims 3—5 are rejected under 35 U.S.C. § 103(a) as unpatentable over
Belhe and Avitall (US 2006/0253116 Al, published Nov. 9, 2006).
ANALYSIS
Claims 1, 2, and 6 as anticipated by Belhe
Claim 1 recites a medical device comprising “a resilient member pre­
formed in a curved shape . . . wherein the resilient member is configured to
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Application 12/636,064
buckle when the radial force exceeds a predetermined threshold to prevent
the puncturing of tissue due to excessive pressure.’ '' Appeal Br. 8 (Claims
App., emphasis added). The Examiner finds that Belhe discloses a resilient
member (i.e., wire 60) which inherently buckles when an inward radial
force, exerted by sheath 6, exceeds a predetermined threshold. Final Act. 3.
Continuing, the Examiner finds that it is inherent that Belhe’s resilient
support 60 “will break/buckle if too large a force is applied, as any material
has a predetermined breaking point.” Id. The Examiner notes that “the
predetermined threshold is not explicitly defined except that the resilient
member is configured to buckle to prevent the puncturing [of] tissue due to
excessive pressure.” Id. The Examiner determines that because Belhe
discloses that wire 60 can be made of nitinol, “which is the same material as
the resilient member 60 of the instant invention,” wire 60 “will have the
same material properties as the resilient member of the instant invention and
can be configured to buckle under the same force.” Id. (emphasis added).
Appellant contests the Examiner’s inherency position. Appeal Br. 3.
Particularly, Appellant contends that the Examiner does not provide the
required evidence at least tending to show that the claimed buckling of the
resilient member flows from Belhe’s disclosure. Id. Appellant contends that
the mere fact that its resilient member and Belhe’s are made from the same
material does not mean that both resilient members will buckle under the
same amount of force, that is, buckle to prevent puncturing of tissue due to
excessive pressure. Id. at 3^4. Appellant explains that the type of material
is just one factor when determining the amount of force it will take to buckle
the resilient member, and “[pjrobably the most important factor is the size
and configuration (length, width, thickness, cross-sectional area).” Id. at 4.
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Application 12/636,064
Continuing, Appellant explains that “[t]wo resilient members made of the
same material, but of different lengths, thicknesses, shape, or cross-sectional
areas will not necessarily buckle or fail under the same load.” Id.
Appellant’s contentions are persuasive. To anticipate a claim, a prior
art reference must disclose each and every claim limitation, either explicitly
or inherently. In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). “A
prior art reference may anticipate without disclosing a feature of the claimed
invention if that missing characteristic is necessarily present, or inherent, in
the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va.,
Inc., 602 F.3d 1325, 1336—37 (Fed. Cir. 2010). “Inherency, however, may
not be established by probabilities or possibilities. The mere fact that a
certain thing may result from a given set of circumstances is not sufficient.”
In re Oelrich, 666 F.2d 578, 581 (CCPA 1981).
Appellant’s Specification describes:
Member 60 may comprise, for example, a strut, rod or tube
made from a shape memory material, such as Nitinol....
Resilient member 60 may be made structurally weak enough to
buckle if the pressure against the catheter tip is greater than a
certain predetermined threshold, thus giving an extra measure
of safety against excessive pressure that could otherwise
puncture the vein or heart wall.
Spec. 11:27—12:9 (emphasis added).
As noted correctly by the Examiner, the term “predetermined
threshold” is not described in the Specification. However, claim 1 specifies
that “the resilient member is configured to buckle when the radial force
exceeds a predetermined threshold to prevent the puncturing of tissue due to
excessive pressure.” An ordinary meaning of “configured” is “to set up for
operation esp. in a particular way.” Merriam-Webster’s Collegiate
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Application 12/636,064
Dictionary 261 (11th ed. 2003). See also Aspex Eyewear, Inc. v. Marchon
Eyewear, Inc., 672 F.3d 1335, 1349 (Fed. Cir. 2012) (phrases such as
“configured to” are frequently used to have the meaning “designed to” or
“made to”). Consistent with Appellant’s Specification, we construe the
disputed claim language to mean that the resilient member is designed to, or
made to, “buckle when the radial force exceeds a predetermined threshold to
prevent the puncturing of tissue due to excessive pressure.”
The claimed resilient member is configured not to be able to
withstand an inward radial force greater than the predetermined threshold.
Rather, it will buckle when subjected to such force to prevent puncturing of
tissue in contact with the device that could otherwise occur due to excessive
pressure if such buckling of the resilient member did not occur. That is, the
resilient member is made structurally weak enough to buckle when subjected
to a radial force exceeding a threshold force to prevent such puncturing from
occurring.
We agree with Appellant that Belhe’s mere disclosure that wire 60
can be made from nitinol, alone, does not establish that Belhe’s wire 60 is
designed to, or made to, buckle when subjected to an inward radial force that
exceeds any predetermined threshold. Rather, as explained by Appellant,
other design considerations, including the size and configuration of the
resilient member, will affect the amount of force required to buckle the
resilient member. Indeed, the Examiner acknowledges that “the size and
configuration of the resilient member can effect [sic] the force under which
it will buckle.” Ans. 2. Even assuming that Belhe’s wire 60 will buckle “if
too large a force is applied,” this does not establish that Belhe’s wire 60 is,
necessarily, “configured to buckle when the radial force exceeds a
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Application 12/636,064
predetermined threshold to prevent the puncturing of tissue due to excessive
pressure.” For example, it is possible that Belhe’s wire may not buckle
unless it is subjected to a radial force that would result in “puncturing of
tissue due to excessive pressure.”
The Examiner states, “[i]f the prior art structure is capable of
performing the intended use, then it meets the claim. The resilient member
of Belhe, made of nitinol, can be configured to buckle to prevent the
puncturing of tissue.” Ans. 2 (emphasis added). However, claim 1 recites
that the resilient member “A configured to buckle,” not that it “can be
configured to buckle.” To the extent it is the Examiner’s position that
Belhe’s wire 60 could be configured to buckle, and, specifically, as recited in
claim 1, the Examiner provides no explanation why or how one of ordinary
skill in the art would modify Belhe to arrive at the claimed medical device.
Accordingly, we do not sustain the rejection of claim 1, and claims 2
and 6 depending therefrom, as anticipated by Belhe.
Claims 3—5 over Belhe and Avitall
The Examiner’s use of Avitall does not cure the deficiencies of the
rejection of claim 1, from which claims 3—5 depend. Final Act. 4—5.
Accordingly, we do not sustain the rejection of claims 3—5 as unpatentable
over Belhe and Avitall.
DECISION
The Examiner’s decision to reject claims 1—6 is reversed.
REVERSED
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