Ex Parte Moffarah et al

Patent Trial and Appeal Board

May 29, 2018

14048955 (P.T.A.B. May. 29, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/048,955 10/08/2013 Meir Moffarah
24737 7590 05/31/2018
PHILIPS INTELLECTUAL PROPERTY & STANDARDS
465 Columbus A venue
Suite 340
Valhalla, NY 10595
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.
2013P02513US 9853
EXAMINER
TON, MARTIN TRUYEN
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
05/31/2018 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):
patti. demichele@Philips.com
marianne.fox@philips.com
katelyn.mulroy@philips.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MEIR MOFF ARAH,
JEFFEREY BLEAM, and PETER E. WAGNER
(APPLICANT: AngioScore, Inc.)
Appeal2017-006616
Application 14/048,955 1
Technology Center 3700
Before DONALD E. ADAMS, RY ANH. FLAX, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 1-9 and 30
(Final Act. 2 2). Examiner entered a rejection under 35 U.S.C. § 103(a). We
have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
STATEMENT OF THE CASE
Appellants' disclosure "relates to the field of medical devices, more
specifically to medical devices intended to treat stenosis in the vascular
1 Appellants identify "ANGIOSCORE INC." as the real party in interest
(App. Br. 2).
2 Office Action mailed April 19, 2016.
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Application 14/048,955
system" (Spec. i-f 1 ). Appellants' claim 1 is representative and reproduced
below:
1. A method of dilating a stenosed region in a blood vessel, the
method comprising the steps of:
introducing an angioplasty catheter having a body and a
helical scoring structure having a distal end and a proximal end
carried over a balloon on the body, wherein the helical scoring
structure comprises
a plurality of helical elements that longitudinally
extend from the distal end to the proximal end, wherein
the plurality of helical elements are coupled together at
the distal end and the proximal end, [ ] and
a plurality of stabilizing struts, wherein each of the
stabilizing struts is spaced between and coupled to at
least two adjacent helical elements,
expanding the balloon to dilate the helical scoring
structure within the stenosed region within the blood vessel,
wherein the proximal end of the helical scoring structure moves
distally and the helical scoring structure shortens to
accommodate such distal movement of the proximal and of the
helical scoring structure as the balloon is expanded;
holding the expanded helical scoring structure in place to
disrupt the stenosis; and
deflating the balloon causing the helical structure to
collapse.
(App. Br. 11.)
The claims stand rejected as follows:
Claims 1-9 and 30 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Konstantino3 and Eaton. 4
3 Konstantino et al., US 2005/0021071 Al, published Jan. 27, 2005.
4 Eaton, US 2011/0152905 Al, published June 23, 2011.
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Application 14/048,955
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Appellants' Figure 2 is reproduced below:
FIG.2
Appellants' "Figure 2 is a schematic illustration of an exemplary helical
scoring structure embodiment in accordance with embodiments of
[Appellants'] invention" (Spec. i-f 33).
FF 2. Appellants disclose:
The dilatation device 10 includes a dilatation balloon [], which
may be any conventional angioplasty balloon such as
commonly used by interventional cardiologists or radiologists,
and a helical assembly 14 mounted over or attached to the
dilatation balloon []. The helical assembly 14 also includes at
least one stabilizing strut 11 that couples one longitudinal strut
to an adjacent longitudinal strut. ... For added stability, the
stabilizing struts 11 may be spaced evenly or unevenly along
the longitudinal axis of the helical assembly 14. Helical unit 14
may be attached ... to the catheter shaft proximate to proximal
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and distal ends of the balloon[] by collar-like attachments 15
and 16 (See Fig. 2).
(Spec. i-f 42; see also id. i-f 50 ("Helical unit 14 includes but is not limited to
three wires 19 that are attached to collars 15 and 16 at the proximal end and
distal end, respectively").)
FF 3. Examiner finds that Konstantino teaches Appellants' claimed
invention with the exception of a helical scoring structure that comprises "a
plurality of stabilizing struts, wherein each stabilizing strut is spaced
between and coupled to at least two adjacent helical elements" (Final Act. 4--
5).
FF 4. Konstantino's Figure 2 is reproduced below:
~14
15
FIG. 2
Konstantino's "FIG. 2 is a schematic illustration of an exemplary helical
scoring structure embodiment in accordance with embodiments of
[Konstantino' s] invention" (Konstantino i-f 48 (emphasis omitted)).
FF 5. Konstantino discloses:
The dilation device 10 includes a dilation balloon[], which may
be any conventional angioplasty balloon such as commonly
used by interventional cardiologists or radiologists, and a
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helical or spiral unit 14 mounted over or attached to dilation
balloon[, wherein] ... [h ]elical unit 14 ... may be attached to
the distal end and/or the proximal end of the dilation balloon[]
by collar-like attachment elements 15 and 16.
(Konstantino i-fi-1 77-78 (emphasis omitted); see also id. i1 85 ("Helical unit
14 includes three wires 19 that are attached to collars 15 and 16 at the
proximal end and distal end, respectively" (emphasis omitted)).)
FF 6. Konstantino' s Figure 1 7b is reproduced below:
25~
252
Fig. 17b
Konstantino' s Fig. 17b illustrates an embodiment of Konstantino' s
disclosure, wherein an attachment structure 258 is disposed between the
scoring structure 252 and the catheter body (see Konstantino i-fi-163---64; see
also id. i-f l 08).
FF 7. Konstantino discloses that scoring structure 252 is located external to
a balloon, wherein
as [the] balloon[] is expanded, external structure 252 expands
in circumference and contracts axially along the catheter body
[], creating axial force A on attachment structure 258.
Attachment structure 258, fixed to the catheter at its end 266,
axially stretches to accommodate the axial movement of the
external structure 252. External structure 252 also tends to
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rotate about the catheter body 256, causing a torsional force T.
The distal end [] of attachment structure 258 rotates through the
full range of motion of scoring structure 252 to accommodate
torsional force T, while proximal end 266 remains stationary
with respect to [the] catheter body [].
(Konstantino i-f 108 (emphasis omitted).)
FF 8. Konstantino discloses that "[t]he compliance of the balloon and the
scoring element( s) should be chosen to assure uniform expansion of the
balloon substantially free from 'dog-boning' as the combined structure
expands within a lesion" (Konstantino i-f 77; see id. (Konstantino discloses
that "[i]f a compliant or a semi-compliant balloon is used and the
compliance of the scoring element was not matched to comply with the
properties of the balloon, the expansion of the balloon-scoring element
system will not be uniform" and "[t ]his non-uniformity may impair the
efficacy of the scoring catheter and, in some cases, may result in poor
performance")).
FF 9. Eaton "relates generally to medical devices and more particularly to
balloon catheters" (Eaton i-f 1 ).
FF 10. Eaton's Figure 2 is reproduced below:
Eaton's "FIG. 2 is a side elevation view of the distal end of [Eaton's] scoring
balloon catheter in an expanded configuration" (Eaton i-f 21 ).
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FF 11. Eaton's
scoring structure 120 may be formed of a plurality of structural
members 122 connected by bends in an undulating pattern, and
appears much like a balloon or self-expanding stent. However,
unlike a self-expanding stent which has a fully expanded
relaxed configuration, the scoring structure 120 has a relaxed
configuration in which the diameter is reduced. Furthermore,
because the scoring structure's 120 relaxed position is at its
reduced diameter, it differs from a balloon expandable stent in
that upon being expanded by the dilation balloon 100, the
scoring structure 120 returns to its relaxed, reduced diameter
state, as described below in detail. Thus, the scoring structure
120 expands and contracts with the inflation and deflation of
the balloon 100 and is not capable of being implanted to
support a body lumen. Stated differently, the scoring structure
120 is not capable of acting as a stent.
(Eaton i-f 47; see also id. i-f 48 (Eaton's "structural members 122 are
connected in an undulating pattern to form ring structures 125 having a
substantially cylindrical shape," wherein "[e]ach of the ring structures 125
are connected by longitudinal connecting members 124, resulting in a
substantially continuous scoring structure 120 that extends substantially the
entire length and circumference of the working region").)
ANALYSIS
Based on the combination of Konstantino and Eaton, Examiner
concludes that, at the time Appellants' invention was made, it would have
been prima facie obvious to include Eaton's longitudinal connecting
members 124 in Konstantino' s helical scoring structure "to provide a
substantially continuous scoring structure that extends substantially the
entire length and circumference of the working region ... and to produce a
scoring pattern having a plurality of longitudinally staggered substantially
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straight-lines for engaging a calcified [lesion]" (Final Act. 5 (citing Eaton
i-fi-1 48 and 54)). In this regard, Examiner asserts that "Konstantino ...
[discloses] that the compliance of the scoring elements 'should be chosen to
assure uniform expansion',"
[t]he addition of the connecting members to the Konstantino
scoring structure[] [] may also contribute to stabilizing the
scoring structure, may still contribute to a continuous scoring
structure that extends the entire length of the working region,
particularly in instances where the scoring structure does not
make a full rotation [and] [a]lthough the scoring structure of[]
Konstantino may be capable of producing a continuous scoring
structure, a person having ordinary skill in the art would fully
recognize that the addition of the connecting members would
assist in creating a continuous scoring structure[] in other
scenarios when rotation of the scoring structure may be
difficult.
(Ans. 2-3.) We are not persuaded.
On this record, Examiner has, at best, established that separate
elements of Appellants' claim were known in the art.
Obviousness[, however,] requires more than a mere
showing that the prior art includes separate references covering
each separate limitation in a claim under examination. KSR
Int'! Co. v. Teleflex Inc., 550 U.S. 398, 418, 127 S.Ct. 1727,
167 L.Ed.2d 705 (2007). Rather, obviousness requires the
additional showing that a person of ordinary skill at the time of
the invention would have selected and combined those prior art
elements in the normal course of research and development to
yield the claimed invention. Id. at 421, 127 S.Ct. 1727.
Unigene Laboratories, Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir.
2011 ). As Appellants explain, "there is no disclosure in either [of
Konstantino or Eaton] teaching one of skill in the art [] the need to add the
connecting members 124 from Eaton to Konstantino in order [to] stabilize
the scoring structure in Konstantino during expansion" (App. Br. 8; see FF
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6). In addition, although Examiner asserts that Eaton's connecting members
provide a stabilizing function (see Final Act. 5), Examiner failed to identify,
and we do not find, a disclosure in Eaton to support Examiner's assertion.
See In re Kahn, 441F.3d977, 988 (Fed. Cir. 2006) ("rejections on
obviousness grounds cannot be sustained by mere conclusory statements;
instead, there must be some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness"). At best,
Eaton's connecting members 124 provide a connection between the plurality
of structural members 122 of Eaton's scoring structure 120 (see FF 10-11),
which would otherwise be unconnected. Konstantino' s device does not
share this configuration. In contrast, the wires 19 of Konstantino' s scoring
structure 14, 252 extend longitudinally and "may be attached to the distal
end and/or the proximal end of the dilation balloon[] by collar-like
attachment elements 15 and 16" (see FF 4--7). Examiner failed to
adequately explain why a person of ordinary skill in this art would have
found it prima facie obvious to use Eaton's connecting members to connect
the wires ofKonstantino's scoring structure. See Kahn, 441 F.3d at 988.
Further, as Appellants explain, Eaton's "connecting mechanism [124]
... limits the expansive capability of [Eaton's] scoring structure 120 to that
of the radial direction" (App. Br. 7; see FF 9-11). In contrast, Konstantino's
"scoring structure [14, 252] ... includes helical elements connected at their
proximal and distal ends, thereby providing the scoring structure with the
capability of expanding and collapsing both radially and axially" (App. Br.
8; see FF 6-7). Examiner failed to explain how Eaton or Konstantino, alone
or in combination, teach a person of ordinary skill in this art "how to add the
connecting members 124 from Eaton to Konstantino in a way that will allow
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the scoring structure in Konstantino to expand radially and contract[]
axially" (App. Br. 8; see id. (Appellants contend that neither of Eaton or
Konstantino, alone or in combination, provide such a teaching); see
generally FF 6-7).
We recognize Examiner's assertion that "a person having ordinary
skill in the art would fully recognize that the addition of the connecting
members would assist in creating a continuous scoring structure[] in other
scenarios when rotation of the scoring structure may be difficult" and, thus,
"[t]he addition of the connecting members to the Konstantino scoring
structure, [] may also contribute to stabilizing the scoring structure, [and]
may still contribute to a continuous scoring structure that extends the entire
length of the working region" (Ans. 2-3). As Appellants explain, however,
Examiner's rationale is "speculative" (Reply Br. 3). We agree. See Kahn,
441 F .3d at 988.
To be complete, we agree with Appellants' contention that
Konstantino's disclosure regarding the prevention of "'dog-boning' and
promoting uniform radial expansion ... does not necessarily imply that the
distance between helical elements remains the same" (Reply Br. 6; see FF 8;
cf Ans. 3).
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness. The rejection of claims 1-9 and 30
under 35 U.S.C. § 103(a) as unpatentable over the combination of
Konstantino and Eaton is reversed.
REVERSED
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