Ex Parte Stangenes et al

Patent Trial and Appeal Board

Jul 31, 2017

13685250 (P.T.A.B. Jul. 31, 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.
13/685,250 11/26/2012 Todd R. Stangenes 0B-057102US/82410.1494 5441
55962 7590
Wiley Rein LLP
Patent Administration
1776 K Street, NW
Washington, DC 20006
EXAMINER
DANG, ANH TIEU
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
08/02/2017 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):
ptodocket @ wileyrein. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TODD R. STANGENES and SAURAV PAUL
Appeal 2015-005864
Application 13/685,2501
Technology Center 3700
Before: MICHAEL C. ASTORINO, NINA L. MEDLOCK, and
ROBERT J. SILVERMAN, Administrative Patent Judges.
SILVERMAN, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
The Appellants appeal under 35 U.S.C. § 134(a) from the Examiner’s
decision rejecting claims 1—8 and 14—16. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM and enter a NEW GROUND OF REJECTION under
37 C.F.R. § 41.50(b).
1 The Appellants identify St. Jude Medical, Atrial Fibrillation Division, Inc.
as the real party in interest. Appeal Br. 2.
Appeal 2015-005864
Application 13/685,250
ILLUSTRATIVE CLAIM
1. A medical device comprising:
an elongate tubular member having a lumen extending
therethrough in a longitudinal direction, wherein the elongate
tubular member comprises
a distal portion having a wall;
a port opening extending through the wall, the port
opening having a distal edge and a proximal edge; and
a guiding surface within the lumen of the elongate
tubular member, the guiding surface having a distal end,
wherein the distal end of the guiding surface extends
adjacent to the distal edge of the port opening; and
a flexible puncture member insertable through the lumen
of the elongate tubular member, the flexible puncture member
having a distal portion and a proximal portion,
wherein the flexible puncture member deflects upon
contacting the guiding surface to exit the elongate tubular
member through the port opening, and
wherein the distal portion of the flexible puncture
member is biased into an atraumatic shape along its direction of
travel from the elongate tubular member after exiting the
elongate tubular member by a distance sufficient to puncture
the interatrial septum.
REJECTIONS
I. Claims 1—8 and 14—16 are rejected on the ground of
nonstatutory double patenting as being unpatentable over claims 1—18 of
US 8,317,810 B2.
II. Claims 1—5 and 14—16 are rejected under 35 U.S.C. § 102(b) as
being anticipated by Selmon et al. (US 2006/0276749 Al, pub. Dec. 7, 2006,
hereinafter “Selmon”).
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Application 13/685,250
III. Claims 6—8 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Selmon and Simpson et al. (US 6,752,804 B2, iss.
June 22, 2004, hereinafter “Simpson”).
FINDINGS OF FACT
The findings of fact relied upon, which are supported by a
preponderance of the evidence, appear in the following Analysis.
ANALYSIS
Double-Patenting Rejection
The Appellants do not address the double-patenting rejection set forth
in the Final Office Action (pages 3—5). Accordingly, this rejection is
summarily sustained.
New Ground of Rejection and
Anticipation and Obviousness Rejections
The Appellants argue that claim 1 was rejected erroneously, because
Selmon does not teach the claimed “flexible puncture member” that is
“biased into an atraumatic shape,” “after exiting the elongate tubular
member by a distance sufficient to puncture the interatrial septum.” Appeal
Br. 8-10; see also Reply Br. 4. The argument turns upon whether Selmon’s
device teaches a “puncture member” with the recited “atraumatic shape.”
The Examiner maintains that the distal portion of Selmon’s cannula
attains an “atraumatic shape,” because it is “biased into a smooth curve”
after exiting from the tubular member that retained it, such that it “does not
puncture any tissue when the flexible puncture member continues to be
extended from the port opening.” Answer 2—3 (citing Selmon | 88).
According to the Appellants, “the shape of the claimed device
changes after puncturing the interatrial septum to a shape that, if it comes
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Application 13/685,250
into contact with tissue as it continues to advance (e.g., the atrial free wall),
it will not cause trauma thereto.” Appeal Br. 9. By contrast, Selmon’s
cannula 114 has an exposed and sharpened tip 116, protruding from lateral
opening 122 of a tubular member, and will “if it encounters tissue, render
trauma thereto.” Id. (citing Selmon, Fig. 9).
In order to understand the meaning of an “atraumatic shape” of a
puncture element and its “atraumatic” nature, we turn to the Appellants’
Specification, which explains:
Adoption of a pre-formed shape by distal end 120 [of the
flexible puncture member 118] is advantageous in several
respects. For example, the atraumatic, pre-formed shape helps
prevent inadvertent puncture of internal structures, for example
the left atrial free wall during transseptal procedures. In this
example, even if the flexible puncture member 118 is advanced
too far beyond the fossa ovalis, the atraumatic, preformed shape
will prevent inadvertent puncture of the left atrial free wall.
Spec. 1 54. Further, “although the distal end of the flexible puncture
member is described as adopting a helical, basket, or flower shape, one of
ordinary skill in the art will appreciate that other atraumatic, pre-formed
shapes may also be utilized to good advantage in connection with the present
invention.” Id. 171. The exemplary helical, basket, and flower “atraumatic,
pre-formed shapes” (id.) — which also serve to “anchor” the device, during
various procedures (id. | 54) — are shown in Figures 3 A—3C (id. ]Hf 35—37,
55, Figs. 3A—3C). Whatever “atraumatic” shape is employed, however, the
Specification indicates its critical feature — i.e., if the puncture member
were “advanced too far beyond” the intended site, “the atraumatic,
preformed shape will prevent inadvertent puncture” of other anatomical
features. Id. 1 54.
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Appeal 2015-005864
Application 13/685,250
Yet, ultimately, the Specification does not pronounce even the
disclosed helical, basket, and flower embodiments as “atraumatic” in an
absolute sense, such that they would prevent inadvertent puncture of any
anatomical structure in any situation. Rather, particular circumstances —
e.g., involving the device’s position relative to anatomical structures, the
delicacy of such anatomical structures, and the motion of the device — are
required to render the “distal portion of the flexible puncture member”
“atraumatic,” per claim 1. Although the portions of the Specification,
referenced above, primarily concern puncturing the interatrial septum, the
Specification also explains that “[t]he present invention pertains generally to
devices and methods for puncturing tissue within the body.” Spec. 12.
Indeed, even though claim 1 refers to “a distance sufficient to puncture the
interatrial septum,” the structural feature so recited is merely one of
dimension (“a distance”) that might apply in any number of
implementations, rather than only the context of surgery involving
puncturing the interatrial septum.
In view of such professedly general usage, it is not reasonably
possible to interpret the claim term “atraumatic” as having sufficient clarity
to satisfy 35 U.S.C. § 112,12 (pre-AIA) or 35 U.S.C. § 112(b) (AIA).2 See
In re Packard, 751 F.3d 1307, 1313 (Fed. Cir. 2014) (per curiam).
Accordingly, in the same manner that claim indefmiteness may moot
an obviousness rejection, see In re Steele, 305 F.2d 859, 862—63 (CCPA
1962), we apply the same principle in the present rejection of claim 1 under
2 Because the Application in this Appeal was filed after September 16,
2012, we understand that the AIA designation applies. See Leahy-Smith
America Invents Act, Pub. L. No. 112-29, § 4(c)-(e), 125 Stat. 284
(Sept. 16, 2011) (effective Sept. 16, 2012).
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Application 13/685,250
35 U.S.C. § 102(b), because a prior art rejection should not be sustained if
the hypothetical person of ordinary skill in the art would have to make
speculative assumptions concerning the meaning of claim language.
Therefore, we reverse the rejection of claim 1, pro forma, and — pursuant to
our authority under 37 C.F.R. § 41.50(b) — impose a New Ground of
Rejection, under 35 U.S.C. § 112(b), for not particularly pointing out and
distinctly claiming the subject matter that the Appellants regard as the
invention. It should be understood, however, that our decision in this regard
is based solely on the indefmiteness of the claimed subject matter. As such,
our decision does not reflect on the adequacy of the prior art evidence
applied in support of the rejection.
The same claim indefmiteness issue applies to independent claim 15
and to dependent claims 2—5, 14, and 16. Therefore, the rejection of these
claims under 35 U.S.C. § 102(b) is likewise reversed, pro forma, in view of
the New Ground of Rejection, under 35 U.S.C. § 112(b), based on claim
indefmiteness.
For the same reason, we reverse the rejection of dependent claims 6—8
under 35 U.S.C. § 103(a), pro forma, in favor of the New Ground of
Rejection, under 35 U.S.C. § 112(b), based on claim indefmiteness.
DECISION
We summarily AFFIRM the Examiner’s decision rejecting claims 1—8
and 14—16 on the ground of nonstatutory double patenting.
We REVERSE the Examiner’s decision rejecting claims 1—5 and 14-
lb are rejected under 35 U.S.C. § 102(b).
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Application 13/685,250
We REVERSE the Examiner’s decision rejecting claims 6—8 are
rejected under 35 U.S.C. § 103(a).
We ENTER A NEW GROUND OF REJECTION for claims 1-8 and
14—16 under 35 U.S.C. § 112(b), as indefinite.
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b). Section 41.50(b) provides that “[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review.” Section 41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the prosecution
will be remanded to the examiner. The new ground of rejection
is binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the
opinion of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the
claims, appellant may again appeal to the Board pursuant to this
subpart.
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in MPEP § 1214.01.
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Appeal 2015-005864
Application 13/685,250
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED; 37 C.F.R, $ 41.50(b)
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