Ex Parte Hackett

Patent Trial and Appeal Board

Apr 9, 2018

13746712 (P.T.A.B. Apr. 9, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/746,712 01122/2013
530 7590 04/11/2018
LERNER, DAVID, LITTENBERG,
KRUMHOLZ & MENTLIK
600 SOUTH A VENUE WEST
WESTFIELD, NJ 07090
FIRST NAMED INVENTOR
Steven S. Hackett
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.
STJUDE 3.0-200 1025
EXAMINER
DANG, ANH TIEU
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
04/11/2018 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):
eOfficeAction@ldlkm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEVEN S. HACKETT
Appeal2017-005134
Application 13/746,712
Technology Center 3700
Before RICHARD M. LEBOVITZ, JEFFREY N. FRED MAN, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a
permeable plug for a blood vessel. The Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
Statement of the Case
Background
"A frequent risk in medical procedures is the risk that the procedure
will give rise to the formation of potentially life-threatening debris in the
patient's bloodstream" (Spec. i-f 2). "For example, during coronary
interventions, plaque may become dislodged and/or thrombi may form, both
of which could migrate to the carotid arteries via the greater vessels,
1 Appellant identifies the Real Party in Interest as St. Jude Medical, Inc. (see
App. Br. 2).
Appeal2017-005134
Application 13/746,712
possibly blocking the carotid arteries and causing a stroke" (id.). "It has
been recognized that the risk of stroke associated with medical procedures
can be reduced by using a filter to protect those vessels which are at risk"
(id. ii 3).
The Claims
Claims 1-17 are on appeal. Independent claim 1 is representative and
reads as follows:
1. A permeable plug for a blood vessel, comprising:
a body formed from a filtering material having a
collapsed configuration and an expanded configuration, the
body in the expanded configuration being sized and shaped
to occupy substantially an entire cross-section of the blood
vessel, and the material of the body having a radial strength
sufficient to maintain the body's position within the blood
vessel in the presence of flowing blood when the body is in
the expanded configuration in the blood vessel, yet low
enough to avoid blood vessel damage in the event that the
body in the expanded configuration is dragged along the
blood vessel; and
at least one stud having a first end connected to the
body and a free end, the first end having a first cross-section
and the free end having a second cross-section that is larger
than the first cross-section.
The Issues
A. The Examiner rejected claims 1, 6, 7, and 12-14 under 35 U.S.C.
§ 103(a) as obvious over Domingo2 and Sos3 (Final Act. 4---6).
B. The Examiner rejected claims 2-5, 10, and 17 under 35 U.S.C.
§ 103(a) as obvious over Domingo, Sos, and Greenhalgh4 (Final Act. 6-8).
2 Domingo et al., US 2007/0186933 Al, published Aug. 16, 2007.
3 Sos, US 2009/0163926 Al, published June 25, 2009.
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Application 13/746,712
C. The Examiner rejected claim 8 under 35 U.S.C. § 103(a) as obvious
over Domingo, Sos, and Galdonik '062 5 (Final Act. 8-9).
D. The Examiner rejected claims 9 and 16 under 35 U.S.C. § 103(a) as
obvious over Domingo, Sos, and Galdonik '575 6 (Final Act. 9).
E. The Examiner rejected claim 11 under 35 U.S.C. § 103(a) as obvious
over Domingo, Sos, and McCartney7 (Final Act. 9-10).
F. The Examiner rejected claim 15 under 35 U.S.C. § 103(a) as obvious
over Domingo, Sos, McCartney, and Weiss8 (Final Act. 10-11).
A. 35 US.C. § 103(a) over Domingo and Sos
The Examiner finds Domingo teaches "an implant (abstract)
comprising a body ( 14) formed from a filtering material ... having a
collapsed configuration and an expanded configuration" and a "stud ... to
be coupled with a snare" (Final Act. 4, citing Domingo i-fi-1 6, 9 and Fig.
l lA). The Examiner finds Domingo teaches
the material of the body having a radial strength sufficient to
maintain the body's position within the blood vessel in the
presence of flowing blood when the body is in the expanded
configuration in the blood vessel, yet low enough to avoid
blood vessel damage in the event that the body in the
expanded configuration is dragged along the blood vessel.
(Final Act. 4, citing Domingo, abstract).
The Examiner acknowledges Domingo does not teach a device with
the "free end having a second cross-section that is larger than a first cross-
section of the first end" (Final Act 5), but finds Sos teaches a "body formed
4 Greenhalgh et al., US 2008/0119886 Al, published May 22, 2008.
5 Galdonik et al., US 7,879,062 B2, issued Feb. 1, 2011.
6 Galdonik et al., US 2009/0326575 Al, published Dec. 31, 2009.
7 McCartney, US 2006/0247572 Al, published Nov. 2, 2006.
8 Weiss, US 6,676,694 Bl, issued Jan. 13, 2004.
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Appeal2017-005134
Application 13/746,712
of a filtering material (13) and at least one stud (12) ... having a second
cross-section that is larger than the first cross section" (Final Act. 5).
The Examiner finds the combination of Domingo and Sos renders the
claims obvious because both references teach "art-recognized blood vessel
implant retrieval structures engaging snares at the time of the invention and
it has been held that mere substitution of art-recognized equivalents involves
routine skill in the art" (Final Act. 5).
The issue with respect to obviousness is: Does the evidence of record
support the Examiner's conclusion that Domingo and Sos suggest a plug
device body with
a radial strength sufficient to maintain the body's position
within the blood vessel in the presence of flowing blood
when the body is in the expanded configuration in the blood
vessel, yet low enough to avoid blood vessel damage in the
event that the body in the expanded configuration is dragged
along the blood vessel
as required by claim 1?
Findings of Fact
1. Domingo teaches "self-expanding flow restrictive elements may
be delivered to airways of the lung for performing endobronchial lung
volume reduction surgery" (Domingo i-f 6).
2. Domingo teaches: "Typically, the flow restrictive element is a
self-expanding flow restrictive stent comprising an elastic scaffold covered
by a gas impermeable barrier" (Domingo i-f 6).
3. Domingo teaches in "other cases, the flow restrictive element
comprises a one-way valve which allows air to be expelled from the isolated
lung segment but prevents air from entering said segment" (Domingo 6).
4. Figures 1 lA and 1 lB of Domingo are reproduced below:
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Application 13/746,712
FIG. 11A
Fl- ·~•·18 '· { "' ~: ~ . $. '""".-~ ~ ~· .
The loop 50 snaring a proximal end of the stent 14 is
shown in FIGS. llA and llB. The loop tightens down on
the proximal end of the stent snaring it. This action
maintains a hold of the stent to the delivery system. Tension
on the wire or string tightens the loop and maintains a hold
of the stent. Releasing the tension or applying compression
on the wire or string loosens the loop which allows the stent
to be released from the delivery system. The stent in FIGS.
llA and llB is completely unsheathed but the snare is
maintaining a hold of it.
(Domingo i-f 65).
5. Sos teaches "a universal capture assembly 12 of an expanded
device, such as, a vena cava filter 11. When deployed in the path of the
bloodstream, typically in the inferior vena cava, the filter 11 captures blood
clots of a predetermined size and prevents them from traveling further
toward the lungs" (Sos i-f 34 ).
Principles of Law
A prima facie case for obviousness "requires a suggestion of all
limitations in a claim," CFMT, Inc. v. Yieldup Int'! Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) and "a reason that would have prompted a person of
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Application 13/746,712
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does." KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
Analysis
Appellant contends "Domingo does not disclose Applicant's radial
strength feature" (App. Br. 5). Appellant contends
Domingo does not contemplate placing its element in a
blood vessel, let alone constructing such element from a
material having a radial strength sufficient to maintain the
element's position within a blood vessel in the presence of
flowing blood yet low enough to avoid blood vessel damage
in the event that the element is dragged along a blood vessel.
(Id.). Appellant contends "Domingo does not even mention placing its
'implant' in a blood vessel. Indeed, the word 'blood' appears only once in
Domingo, in paragraph [0003], as part of a general statement regarding the
many types of tubular structures within the human body" (App. Br. 6).
The Examiner responds "the claim requires the body to have a radial
strength, however, the recitation of the implant being positioned within the
blood vessel is a functional limitation, since the limitation is based on the
usage of the body of the device within a blood vessel" (Ans. 3). The
Examiner finds:
Since Domingo discloses an implant made of a material
having an expanded configuration, the implant has a radial
strength and is capable of maintaining the implants position
within an arbitrary blood vessel, since there are many
different sized blood vessels and blood flow rates within
different sized and types of bodies of different animals with
which the implant can be delivered to meet these functional
limitations.
(Ans. 3--4).
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Application 13/746,712
We agree with Appellant. While the radial strength is, in part, a
functional recitation, the functional recitation imposes particular structural
consequences on the blood vessel device, namely, the strength to maintain it
in the body position while not damaging the blood vessel if dragged along it.
In order to rely upon inherency, the Examiner needs to identify some reason
to believe that a particular implant composition within Domingo would
inherently satisfy the "radial strength" requirements in order to establish a
prima facie case of anticipation and allow Appellant an opportunity to rebut
this prima facie case. In the seminal case, In re Best, the Court approved
placing the burden on Appellants to demonstrate that the prior art did not
inherently possess the characteristics of the claimed product, but the prior art
in Best recited specific testable starting material compositions with which
the asserted inventive materials could be compared. See In re Best, 562 F.2d
1252, 1253, 1255 (CCPA 1977).
In this case, the Specification does identify specific materials from
which the body may be formed with the required radial strength (see, e.g.,
Spec. i-f 13). However, the Examiner does not demonstrate that a
composition in Domingo is identical or substantially similar to compositions
in the Specification with the recited "radial strength" requirement, nor does
the Examiner identify any teaching of a particular composition in Domingo
that would have been expected to inherently have the "radial strength"
requirement.
Therefore, because Domingo is drawn to placement of elements in the
lung (FF 1 ), where the fluid is air, not the more viscous fluid of blood as
recited in the claim, we agree with Appellant that in the absence of either
evidence that the "radial strength" requirement would necessarily have been
met by Domingo, or a specific prior art embodiment in Domingo which
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Appellant could test to verify or rebut the inherency position, the Examiner
has not established a prima facie case that the combination of Domingo and
Sos inherently satisfy the "radial strength" requirement of claim 1.
Conclusion of Law
The evidence of record does not support the Examiner's conclusion
that Domingo and Sos suggest a plug device body with
a radial strength sufficient to maintain the body's position
within the blood vessel in the presence of flowing blood
when the body is in the expanded configuration in the blood
vessel, yet low enough to avoid blood vessel damage in the
event that the body in the expanded configuration is dragged
along the blood vessel
as required by claim 1.
B.-F. 35 US.C. § 103(a)
The Examiner relies upon Domingo and Sos for each of these
rejections to teach the radial strength limitation of independent claim 1 (see
Final Act. 6-11 ). Having reversed the obviousness rejection of claim 1 over
Domingo and Sos for the reasons given above, we also find that the further
combinations with Greenhalgh, Galdonik '062, Galdonik '575, McCartney,
and Weiss do not render the rejected claims obvious for the same reason.
SUMMARY
In summary, we reverse the rejection of claims 1, 6, 7, and 12-14
under 35 U.S.C. § 103(a) as obvious over Domingo and Sos.
We reverse the rejection of claims 2-5, 10, and 17 under 35 U.S.C.
§ 103(a) as obvious over Domingo, Sos, and Greenhalgh.
We reverse the rejection of claim 8 under 35 U.S.C. § 103(a) as
obvious over Domingo, Sos, and Galdonik '062.
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We reverse the rejection of claims 9 and 16 under 35 U.S.C. § 103(a)
as obvious over Domingo, Sos, and Galdonik '575.
We reverse the rejection of claim 11under35 U.S.C. § 103(a) as
obvious over Domingo, Sos, and McCartney.
We reverse the rejection of claim 15 under 35 U.S.C. § 103(a) as
obvious over Domingo, Sos, McCartney, and Weiss.
REVERSED
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