Ex Parte KER¿NEN

Patent Trial and Appeal Board

May 31, 2016

12850539 (P.T.A.B. May. 31, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/850,539 08/04/2010
37374 7590 06/03/2016
INSKEEP INTELLECTUAL PROPERTY GROUP, INC
2281W.190TH STREET
SUITE 200
TORRANCE, CA 90504
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.
21948-557 1041
EXAMINER
PRESTON, REBECCA STRASZHEIM
ART UNIT PAPER NUMBER
3738
NOTIFICATION DATE DELIVERY MODE
06/03/2016 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):
inskeepstaff@inskeeplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte OLLI KERANEN
Appeal2014-003838
Application 12/850,539
Technology Center 3700
Before MICHAEL L. HOELTER, ANNETTE R. REIMERS, and
MARK A. GEIER, Administrative Patent Judges.
REIMERS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Olli Keranen (Appellant) appeals under 35 U.S.C. § 134(a) from the
Examiner's decision to reject under 35 U.S.C. § 102(e): (1) claims 1-7, 11,
13, and 14 as anticipated by Sahatjian (US 2005/0010275 Al; pub. Jan. 13,
2005); and (2) claims 1, 8-10, and 14 as anticipated by Sharkawy (US
7,186,265 B2; iss. Mar. 6, 2007), and under 35 U.S.C. § 103(a) claims 1-3,
7, 11, 13, and 14 as unpatentable over Tremulis (US 2003/0069593 Al; pub.
Apr. 10, 2003) and Moaddeb (US 2005/0288781 Al; pub. Dec. 29, 2005).
Claim 12 has been cancelled. Appeal Br. 2. We have jurisdiction under 35
U.S.C. § 6(b).
We REVERSE.
Appeal2014-003838
Application 12/850,539
CLAIMED SUBJECT MATTER
The claimed subject matter "relates to heart valve repair techniques
and annuloplasty devices." Spec. i-f 2; Figs. 4a, 4b, 5. Claims 1 and 14 are
independent.
Claim 1 is illustrative of the claimed subject matter and recites:
1. A heart valve annuloplasty system for improving the
function of a heart valve comprising:
a first loop-shaped support, which is configured to abut a
first side of said heart valve,
a second loop-shaped support, which is configured to abut
a second side of said heart valve opposite to said first side such
that said heart valve is trapped between said first looped-shaped
support and said second loop-shaped support;
said second loop-shaped support having an outer boundary
which is greater than an outer boundary of said first loop-shaped
support
said first loop-shaped support and said second loop-shaped
support each being formed from a magnetic material, such that,
when subjected to an externally applied magnetic field, said first
loop-shaped support and said second loop-shaped support, \vhen
arranged on radially displaced opposing sides of the heart valve,
are attracted to each other by said magnetic field for holding said
first loop-shaped support and said second loop-shaped support
on opposing sides of the heart valve.
ANALYSIS
Anticipation by Sahaljian
Claims 1-7, 11, 13, and 14
Independent claim 1 calls for, in relevant part, a first loop-shaped
support and a second loop-shaped support "each being formed from
magnetic material" and "when arranged on radially displaced opposing sides
of the heart valve, are attracted to each other by said magnetic field for
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Application 12/850,539
holding said first loop-shaped support and said second loop-shaped support
on opposing sides of the heart valve." Appeal Br. 20, Claims App.
(emphasis added).
The Examiner finds that Sahatjian teaches the limitations of claim 1
including the limitations directed to the first loop-shaped support and the
second loop-shaped support each being formed from a magnetic material
and being attracted to each other by the magnetic field. See Final Act. 3-5.
In particular, the Examiner finds:
The entire system (stent 100) maybe [sic] formed from (include)
a magnetic material (magnetic particles), such that when the first
and second loop shaped supports (the loop within portions 140,
160) will move towards each other (as they transition from a
delivery to a deployed configuration) when exposed to an
externally applied magnetic field.
Id. at 4 (citing Sahatjian, i-f 77).
The Examiner clarifies her interpretation of the limitations "formed
from" and "attracted to each other" in the Answer as follows:
First, "formed form" has not been assigned a special definition,
as such, [the] Examiner is interpreting "formed from" as an
equivalent to "comprising" meaning it is open ended and merely
requires the loop shaped/ curved shaped supports (the loop
within portion 140 closest to portion 160, and the loop within
portion 160 closest to portion 140) to include some magnetic
material (magnetic particles). Second, during the implantation/
expansion process the loop shaped/ curved shaped supports (the
loop within portion 140 closest to portion 160, and the loop
within portion 160 closest to portion 140) are exposed to an
external magnetic field which helps promote the loop shaped/
curved shaped supports (the loop within portion 140 closest to
portion 160, and the loop within portion 160 closest to portion
140) assume it's deployed state; in the deployed state the loop
shaped/ curved shaped supports (the loop within portion 140
closest to portion 160, and the loop within portion 160 closest to
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Application 12/850,539
portion 140) are prevented from moving further from each other
(i.e. are attracted to each other).
Ans. 6
In specific response to the Examiner's findings that the
Sahatjian stent is "formed from" magnetic material and that portions
140 and 160 of stent 100 would be attracted to one another when
exposed to an externally applied magnetic field, Appellant contends:
The stent disclosed by Sahaljian is made of (i.e. formed
from) a polymer tube or rod . . . The polymer may include a
magnetic heating agent ... such as magnetic particle[s] ... that
are susceptible to heating by magnetic hysteresis effects. The
heating softens the stent, allowing for a balloon to expand the
stent. There is no evidence to suggest that the magnetic particles
are present in sufficient amounts for the plastic rod or tube
containing them to be magnetic. Neither is there any evidence to
suggest that, when subjected to an externally applied magnetic
field, any part of the stent can be attracted to any other part of the
stent. The only movement of one part of the stent relative to
another part of the stent is the radial expansion of the stent by a
balloon located inside the stent. This expansion inherently
moves parts of the stent away from each other, not towards each
other and not by way of an externally applied magnetic field.
Appeal Br. 11 (citing to Sahatjian i-fi-19, 14, 77, and 92; claim 18). As forthe
Examiner's assertion that the portions 140 and 160 of stent 100 "are
prevented from moving further from each other (i.e. are attracted to each
other)" in the deployed state, Appellant contends that: "[t]his interpretation
... appears to be unreasonable on its face." Reply Br. 10.
Appellant's arguments are persuasive. First, the Sahatjian stent is
formed from polymer material (Sahatjian i-fi-1 79, 92), which may include
magnetic particles that are susceptible to heating by magnetic hysteresis (id.
at i1 77). Heating softens the stent to facilitate its radial expansion by an
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Application 12/850,539
expansion balloon. Id. at iii! 68, 69, 7 5. Hence, coils 140, 160 of the
Sahatjian stent move away from one another upon the application of a
magnetic field and inflation of the expansion balloon. They are not attracted
to each other upon expansion. Second, as noted by Appellant, there is no
evidence in Sahatj ian to suggest that the magnetic particles are present in
sufficient amounts for the plastic rod or tube containing them to be
magnetic, or when subjected to an externally applied magnetic field, any part
of the stent is attracted to any other part of the stent. See Appeal Br. 11.
Third, the Examiner supplies no evidence or technical reasoning to support
the contention that coils 140, 160 of Sahatjian's stent 100 being prevented
from moving further from each other in the deployed state necessarily means
that the coils are being "attracted to" each other. See Ans. 6. We agree with
Appellant that such a statement is unreasonable.
Thus, by failing to show that Sahatjian teaches several limitations of
claim 1, the Examiner has not established by a preponderance of the
evidence that Sahatjian anticipates the system recited in claim 1.
Accordingly, we do not sustain the Examiner's rejection of claims 1-
7, 11, and 13 as anticipated by Sahatjian.
Additionally, similar limitations in independent claim 14 resulted in
the same unsupported findings by the Examiner discussed above with
respect to independent claim 1. See Final Act. 3-5. For similar reasons set
forth above for independent claim 1, we likewise do not sustain the
Examiner's rejection of claim 14 as anticipated by Sahatjian.
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Application 12/850,539
Claims 1, 8-10, and 14
Anticipation by Sharkawy
The Examiner finds that Sharkawy teaches the limitations of claim 1.
In particular, the Examiner finds "that the supports (magnetic materials 26,
28) [of Sharkawy] are capable of being positioned such that they abut
opposite sides of valve leaflets/ trapping native leaflets." Final Act 6.
Appellant contends that the trapping of heart valve tissue by specific
structural components, namely, between the loop-shaped supports, is not "all
functional language" and is positively recited structure. See Appeal Br. 13.
Appellant further contends that
Sharkawy discloses that magnets 26 and 28 have polarities
wherein a [magnetic field] between the two causes valve
mechanism 12 and securing mechanism 14 to couple with each
other, collectively defining a securing or locking mechanism .
. . and the magnets are in direct contact with each other ....
The docking ring 14 is sized to fit inside (within) the annulus
and to exert a radially compressive force against the inside wall
of the annulus (the portion remaining after valve excision[)].
Reply Br. 13 (citing Sharkawy, col. 10, 11. 19-38, 54--58; col. 11, 11. 3---6);
see also Appeal Br. 14. In addition, Appellant contends that "the
[Sharkawy] device is configured to compress against the annulus from the
inside after the leaflets are cut away. There is no evidence to suggest that
the magnets 26 and 28, designed for direct contact, would hold together if
separated by the thickness of the annulus." Reply Br. 13.
In regard to the relationship between magnets 26, 28 Sharkawy states:
In either embodiment, when operatively positioned within a
native valve annulus, the two magnets 26 and 28 directly contact
each other in a head-to-toe or a top-to-bottom arrangement and
form a magnetic bond sufficient to provide a fluid-tight seal
between the two and sufficient to maintain the seal during normal
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Application 12/850,539
valve and cardiac motion.
Sharkawy, col. 11, 11. 3-9 (emphasis added).
At the outset, we agree with Appellant that the trapping of heart valve
tissue between the loop-shaped supports constitutes positively recited
structure in claim 1 because it specifies a physical arrangement of the two
loop-shaped supports relative to one another (i.e., they must be configured in
a manner that permits the trapping of the heart valve tissue). Against this
background, we note that magnets 26, 28 of Sharkawy are in direct contact
with each other and do not trap valve tissue therebetween, and that the
Examiner has failed to establish by a preponderance of the evidence that
heart valve tissue is necessarily trapped between magnets 26, 28 of
Sharkawy. See Final Act. 6; see also Ans. 7; Appeal Br. 13; Reply Br. 13.
As such, we do not sustain the Examiner's rejection of claims 1 and
8-10 as anticipated by Sharkawy.
Additionally, similar limitations in independent claim 14 resulted in
the same unsupported findings by the Examiner discussed above with
respect to independent claim 1. See Final Act. 5---6. For similar reasons set
forth above for independent claim 1, we likewise do not sustain the
Examiner's rejection of claim 14 as anticipated by Sharkawy.
Obviousness over Tremulis and Moaddeb
Claims 1-3, 7, 11, 13, and 14
The Examiner finds that Tremulis "discloses the invention
substantially as claimed" (Final Act. 6) except that Tremulis "does not
disclose the loop-shaped supports/ curve-shaped supports to be made from a
magnetic material that are attracted to each other" (Id. at 7). The Examiner
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finds that Moaddeb teaches
an annuloplasty ring made from shape memory material ... and
a conductive coil (magnetic material) .... The conductive coil
(magnetic material) allows the ring to absorb more energy/ heat
causing the shape memory material to better transition to the
memorized shape, the energy source maybe an externally applied
magnetic field.
Id. (emphasis added) (citing Moaddeb, i-fi-1 71, 77). The Examiner concludes
that:
It would have been obvious to one having ordinary skill in
the art at the time the invention was made to include the
conductive coil (magnetic material), as taught by Moaddeb et al.,
in the shape memory material making the loop-shaped supports/
curve-shaped supports (rings 12, 14), as disclosed by Tremulis et
al., such that the system may be activated, to transition shapes,
by a known alternative/ external energy source within the
annuloplasty art.
Id. (emphasis added).
According to Appellant "neither of the cited references teaches an
annuloplasty system comprising two supports that are attracted to one
another by application of an external magnetic field." Appeal Br. 17.
Regarding Tremulis, Appellant states:
The Tremulis annuloplasty device is disclosed as being
made from plastics, shape memory material, silicone and other
materials, ... The shape memory material may be activated from
a first to a second clamping state by use of heat. Tremulis does
not disclose the use of an external magnetic field to attract a first
and a second loop-shaped support or for any other purpose.
Id. at 18 (citing Tremulis, i1 49).
As for Moaddeb, Appellant asserts: "Moaddeb discloses the use of a
magnetic field to contract or decrease the diameter of a ring-shaped device
by a direct ferromagnetic shape memory effect and by heating a
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Application 12/850,539
conventional shape memory material." Id. (citing Moaddeb, iii! 12, 13).
Appellant further notes that neither Tremulis nor Moaddeb disclose "an
annuloplasty device or any other device made from a material that would be
responsive to an externally applied magnetic field to induce attraction
between two support rings." Id. Appellant concludes: "[c]ombining the
teachings of Moaddeb and Tremulis could not result in two loop shapes that
attract each other as claimed because neither reference teaches attraction.
The references only teach shape change, which is distinct from [attraction]."
Id. at 19.
The Examiner responds:
Upon exposure to a magnetic field the magnetic material
(conductive coils), as taught by Moaddeb et al., within the loop
shaped/ curved shaped supports (rings 12, 14), as disclosed by
Tremulis et al., will cause the loop shaped/ curved shaped
supports (rings 12, 14) to move toward each other, toward their
[memorized] shape (i.e. the loop shaped/ curved shaped supports
(rings 12, 14) will be attracted to each other). The loop shaped/
curved shaped supports (rings 12, 14) moving/ being attracted to
their [memorized] shape (which happens to be closer together) is
a result of (i.e. is caused by) stimulus from the external magnetic
field.
Ans. 9.
According to Appellant, however: "the result of the suggested
modification of Tremulis according to Moaddeb would involve the
application of an external magnetic field to heat a memory shape material
and induce a change in shape rather than to attract two parts of the device
toward one another." Reply Br. 14. Appellant continues:
The Examiner asserts that a change in shape of a device
comprising two supports such that the two supports move closer
to one another satisfies the feature recited in claims 1 and 14 of
the two supports being "attracted to" one another. ... Appellant
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Application 12/850,539
Id.
respectfully submits that the Examiner's interpretation of
"attracted to" is not reasonable based upon the plain language
meaning of attraction in the context of an applied magnetic field.
Appellant's arguments are persuasive. The Examiner acknowledges
that Moaddeb teaches an annuloplasty ring that uses an externally applied
magnetic field to cause the shape memory material of the ring "to better
transition to the memorized shape." Final Act. 7. The Examiner also
acknowledges that combining Moaddeb with Tremulis would cause the
Tremulis loop-shaped supports/curve-shaped supports (rings 12, 14) "to
transition shapes." Id. Only after Appellant likewise points out that neither
Tremulis nor Moaddeb teaches magnetic attraction, only shape change (see
Appeal Br. 1 7-19) does the Examiner suggest that the combined
Tremulis/Moaddeb device would result in attraction between the rings 12, 14
of Tremulis by virtue of their being moved toward their memorized shape
(see ii .. ns. 9). Hov,rever, as correctly noted by ii .. ppellant, t\vo things merely
moving closer to one another does not mean that they are attracted to one
another in a magnetic sense. See Reply Br. 14.
The Examiner has thus not provided articulated reasoning based on
rational underpinnings sufficient to support a prima facie case of
obviousness of claim 1 with respect to the limitation of magnetic supports
being attracted to each other by a magnetic field. Accordingly, we do not
sustain the Examiner's rejection of claims 1-3, 7, 11, and 13 as unpatentable
over Tremulis and Moaddeb.
Additionally, similar limitations in independent claim 14 resulted in
the same unsupported findings and conclusions by the Examiner discussed
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Application 12/850,539
above with respect to independent claim 1. See Final Act. 6-7. For similar
reasons set forth above for independent claim 1, we likewise do not sustain
the Examiner's rejection of claim 14 as unpatentable over Tremulis and
Moaddeb.
DECISION
We REVERSE the decision of the Examiner to reject claims 1-11, 13,
and 14.
REVERSED
cda
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