Ex Parte Mauch et al

Patent Trial and Appeal Board

Jun 23, 2016

12706904 (P.T.A.B. Jun. 23, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
121706,904 02/17/2010 Kevin Mauch
28390 7590 06/27/2016
MEDTRONIC VASCULAR, INC
IP LEGAL DEPARTMENT
3576 UNOCAL PLACE
SANTA ROSA, CA 95403
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.
P34560US2 1584
EXAMINER
MILLER, CHERYLL
ART UNIT PAPER NUMBER
3738
NOTIFICATION DATE DELIVERY MODE
06/27/2016 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):
rs.vasciplegal@medtronic.com
medtronic_cv_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KEVIN MAUCH, MELISSA JEFFRIES,
RYAN BIENVENU, and MARIA ARREGUIN
Appeal2014-003470
Application 12/706,904
Technology Center 3700
Before EDWARD A. BROWN, BRANDON J. WARNER, and
LEE L. STEPINA, Administrative Patent Judges.
STEPINA, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134 from a rejection of claims 1-
3, 5-8, 10, and 17-20. 1 We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 Claims 4, 9, and 11-16 have been withdrawn. See Final Act. 1.
Appeal2014-003470
Application 12/706,904
CLAIMED SUBJECT MATTER
The claims are directed to a method for creating a venous valve from
autologous tissue. Claim 1, reproduced below, is illustrative of the claimed
subject matter:
1. A method of creating a venous valve of autologous tissue,
the method comprising the steps of:
transluminally advancing a delivery system having a valve
creation device mounted thereon to a target site within a vein;
and
deploying the valve creation device within the vein such
that the valve creation device in a preset closed configuration
forces opposing portions of a wall of the vein together such that
the opposing portions of the vein wall substantially close a lumen
of the vein and create a valve of autologous vein tissue that
substantially prevents retrograde blood flow through the valve,
wherein the valve creation device changes shape and assumes a
temporary open configuration in response to antegrade blood
flow through the vein such that the opposing portions of the vein
wall separate to allow blood flow through the created valve.
REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Laufer
Thornton
Armstrong
Chu
us 5,810,847
US 2003/0191479 Al
US 2006/0015171 Al
US 2007/0112423 Al
REJECTIONS
Sept. 22, 1998
Oct. 9, 2003
Jan. 19,2006
May 17, 2007
(I) Claims 1-3, 5, 6, 10, and 18-20 are rejected under 35 U.S.C.
§ 102(b) as anticipated by Thornton.
2
Appeal2014-003470
Application 12/706,904
(II) Claims 1-3, 5, 6, 10, and 18-20 are rejected under 35 U.S.C.
§ 102(b) as anticipated by Chu.
(III) Claims 1, 18, and 19 are rejected under 35 U.S.C. § 102(b) as
anticipated by Laufer. 2
(IV) Claims 7 and 8 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Thornton and Armstrong.
OPINION
Rejection (I)
The Examiner finds that Thornton discloses all the features recited in
claim 1 and, in particular, teaches "deploying the device within the vein
(fig.14b, 14c) so that the device (100) in a preset closed configuration forces
opposing portions (leaflets are opposed portions of vein wall) of a wall of
the vein together such that opposing portions (leaflets) substantially close a
vein lumen." Final Act. 4.
Appellants argue that Thornton "does not force opposing portions of
the vein wall together such that the opposing portions of the vein wall
substantially close the lumen of the vessel." Appeal Br. 3. Rather,
according to Appellants, "the closure device 100 of Thornton reduces the
distance between opposing walls of the vein such that the native valve
leaflets close the lumen, not the vein wall." Appeal Br. 3 (referring to
Appellants' Fig. 4 and Fig. 14C of Thornton). Appellants assert that the
Examiner's interpretation of claim 1, specifically, construing the recited
"portions of the vein wall" to include leaflets, is not consistent with
2 The Examiner withdrew a rejection of claim 17 as anticipated by Laufer.
Ans. 9; see also Final Act. 8-9.
3
Appeal2014-003470
Application 12/706,904
Appellants' Specification and is therefore unreasonably broad. See Appeal
Br. 3; see also Reply Br. 3.
In response, the Examiner states, "[t]he native leaflets are extensions
of the vein wall and thus are considered portions of the vein wall. It is noted
that the claims do not exclude (in any form of a negative limitation or
otherwise) the leaflets from being considered part of the vein wall." Ans. 9.
Additionally, under what the Examiner refers to as interpretation #2
(see Attachment 1 provided with the Answer), the Examiner finds that,
"even if the leaflets were to be excluded from being considered portions of
the vein wall, other portions of the vein wall positioned just proximally and
distally and radially of the leaflets are also forced closer together ... to
substantially close the lumen." Ans. 9--10 (referring to copies of Figs. 14A-
14C of Thornton annotated by the Examiner) (underlining added). Referring
to an annotated copy of Figure 14c of Thornton, the Examiner finds that
portions of the vein wall in Thornton are forced toward one another, "which
also in tum forces the leaflets together, which in tum closes the lumen.''
Ans. 10. The Examiner also determines that these non-leaflet portions
themselves "substantially close" the lumen as required by claim 1. Ans. 10.
We reproduce the Examiner's annotated copy of Figure 14C below.
4
Appeal2014-003470
Application 12/706,904
The Examiner's annotated copy of Figure 14C of Thornton depicts a
longitudinal cross-section of a valve closure device within a vessel.
Thornton i-f 24; see also Ans. 10.
In the Reply Brief, Appellants maintain their position with respect to
the difference between the wall of the vein and the leaflets. Reply Br. 1-2.
Additionally, in response to the Examiner's discussion of interpretation #2,
Appellants provide their own annotated versions of Figures 14A and 14C of
Thornton and argue, "[u]sing the Examiner's logic, a door that is 99% fully
open is 'substantially closed' because it is slightly more closed than a door
that is 100% open. Again, this is not a reasonable interpretation." Appeal
Br. 6. Appellants further argue, "claim 1 does not read that opposing
portions of the wall of the vein are forced 'closer towards one another' or
'closer together'. Instead, claim 1 recites that the preset closed configuration
of the valve creation device 'forces opposing portions of the wall of the vein
together."' Reply Br. 2. Appellants contend that claim 1 requires the
opposing portions of the wall to come into contact with each other, and the
Examiner improperly interprets claim 1 as merely requiring the vein walls to
5
Appeal2014-003470
Application 12/706,904
be forced towards each other such that another part of the vein (leaflets 3 8)
substantially close the lumen. See Reply Br. 3---6.
During patent prosecution, claims are given their broadest reasonable
interpretation consistent with the specification, reading the claim language
as it would be interpreted by one of ordinary skill in the art. See In re Am.
Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). We find
Appellants' construction of the "vein wall," as being distinct from the
leaflets, to be consistent with the Specification as understood by one of
ordinary skill in the art. We further note that Appellants' position reiterates
that the scope of the claims is limited to the recited "portions of the vein
wall" being exclusive of leaflets. Based on such a claim construction, and in
view of this claim scope, we agree with Appellants that the Examiner's
construction of "portions of the vein wall" is unreasonably broad in light of
Appellants' Specification and how the term would be understood by one of
ordinary skill in the art.
The Detailed Descnpt10n of the Invention in the Specification refers
to the "wall" as a subcomponent of the vein. See, e.g., Spec. i-f 43 (stating
"[t]he hooked configuration ensures that end portions 320, 324 remain on
the outer or exterior surface of the vein wall and prevent tips 328, 330 from
incidentally becoming dislodged and/ or pushed into the vein resulting in a
possible embolization"); i-f 44 (stating "when valve creation device 316 is
implanted within a vein as further described below the valve creation device
will operably force opposing sites or points on the vessel wall of a vein
together to create a new valve of autologous vein tissue"); see also Figs. 4,
4A; i-f 46 (stating "[p ]articularly, sharpened or pointed tips 328, 330 at the
ends of wire-like structure 317 pierce and penetrate through opposing
portions of the vessel wall of vein 400"); see also Figs. 4, 4A; i-f 49 (stating
6
Appeal2014-003470
Application 12/706,904
"[ w ]ith three sets of contact portions positioned around the circumference of
the vein more complete closure of the lumen of the vein may be had when
the opposing portions of the vessel wall are forced or gathered together by
each wire-like structure").
Appellants' Specification also refers to the valve as a subcomponent
of the vein. See, e.g., Spec. i-f 2 (stating "[ v Jeno us valves are found within
native venous vessels and are used to assist in returning blood back to the
heart in an antegrade direction from all parts of the body"). Further,
Appellants' Specification describes leaflets as a component of a native
valve. See, e.g., Spec. i-f 3 (stating "[ f]or example, the shape of the venous
valve may include leaflets or leaflets with sinuses"). Thus, as described by
Appellants' Specification, the wall of the vein and the native valve (and
leaflets forming this valve) are both subcomponents of the vein.
Appellants' Specification repeatedly refers to leaflets and the wall of
the vein separately from one another. See, e.g., Spec. i-fi-1 44--4 7, 51-59.
Appellants' Specification describes the leaflet as something that moves with
the wall, stating, "specifically, the vessel wall of vein 100 expands into a
pouch or bulge, such that the vessel has a knotted appearance when the
pouch is filled with blood. As the bulging progresses, vein 100 becomes
further enlarged and valve leaflets 106, 108 move farther apart." Spec. i-f 6
(referring to Fig. 2). Appellants' Specification does not appear to describe
the leaflets as being part of the wall, and the Examiner does not provide any
evidence that one of ordinary skill in the art would consider the leaflets to be
part of the wall. Moreover, Appellants' Specification discusses various
locations for the placement of valve creation device 316 (where the new
valve will be created) relative to the location of leaflets of an insufficient
native valve. See Spec. i-fi-1 45, 59, and 68. Furthermore, none of Appellants'
7
Appeal2014-003470
Application 12/706,904
drawings depict the closing action of a valve creation device in which
leaflets are the subcomponent of the vein that operates to restrict blood
flow-instead, it is always the wall of the vein itself that is shown to operate
to restrict blood flow. See Figs. 4, 5, 10, 11, 14--18, 19-24. Indeed, the
leaflets are not shown in any of these figures.
Appellants' Specification indicates that the use of leaflets when
creating a valve in a vein can cause problems, further stating, "[t]he
relatively simple construction of valve creation device 316 does not include
leaflets or hinged flaps that may thicken, tear or fail, avoids tissue ingrowth
of such leaflets, and also avoids pooling of blood within such leaflets that
may result in clots." Spec. i-f 44 (emphasis added). Although this passage
may not categorically exclude the use of valve creation device 316 near
native leaflets, this statement at least implies that the inclusion of leaflets as
part of a created valve presents disadvantages. As such, this passage is
consistent with, for example, Figures 4, 5, 10, 11, 14--18, 19-24.
Further, Appellants' Background of the Invention points out
disadvantages with previous remedies such as (i) prostheses that include
leaflets and (ii) valvuloplasty for repairing leaflets (valve cusps). See Spec.
,-r 7.
Evidence of how a skilled artisan would generally understand
particular words can also come from the prior art. "Prior art references may
be 'indicative of what all those skilled in the art generally believe a certain
term means ... [and] can often help to demonstrate how a disputed term is
used by those skilled in the art."' In re Cortright, 165 F.3d 1353, 1358 (Fed.
Cir. 1999) (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576
1584 (Fed. Cir. 1996)). "Accordingly, the PTO's interpretation of claim
terms should not be so broad that it conflicts with the meaning given to
8
Appeal2014-003470
Application 12/706,904
identical terms in other patents from analogous art." Id. The prior art
references cited by the Examiner support Appellants' above-noted claim
interpretation. For example, Thornton describes "cusps" (leaflets) as
meeting the wall of a blood vessel, rather than being a part of it. Thornton
if 30. Chu lists various problems with venous valves and lists stretched
leaflets and thin venous walls separately. See Chu if 6 (stating: "In addition
to common post-operative complications such as wound hematoma,
infection, lymphatic leak, and thrombosis, failure due to dilation, stenosis,
distorted and thickened valve tissue, overly stretched leaflets, thin venous
walls and other causes occur in a significant population of patients").
Further, Chu describes a distance "h" between walls of its vein and, as
shown in Figure 1 of Chu, this measurement bypasses leaflets 12. See Chu,
Fig. 1; if 64. In other words, when Chu measures a distance between walls
of the vein, Chu avoids taking into account the distance between the leaflets
(which is less than the distance between the walls of the vein). Similarly,
Laufer, referring to Figure 6, describes the wall of the vein and the leaflets
as separate items, stating, "[a ]s the legs of the clip close, the leaflets 70 of
the cusp 25 of the incompetent valve 30 are moved together. Likewise, the
walls 72 of the vein 20 are also drawn together." Laufer, col. 7, 11. 47-50.
In light of Appellants' Specification and the understanding by one of
ordinary skill in the art, we agree with Appellants' contention that the
Examiner's interpretation of claim 1 is unreasonably broad. This conclusion
is further supported by Thornton, Chu, and Laufer, which provide evidence
of how one of ordinary skill in the art would understand a leaflet to be
distinct from, and not a part of, a vein wall. This overly broad claim
interpretation led to the Examiner's finding (based on contact between
leaflets 3 8) that Thornton discloses deploying a valve creation device within
9
Appeal2014-003470
Application 12/706,904
a vein such that the valve creation device in a preset closed configuration
"forces opposing portions of a wall of the vein together such that the
opposing portions of the vein wall substantially close a lumen of the vein."
Under a proper interpretation of claim 1, as detailed above, the recited
"portions of the vein wall" exclude the leaflets. Accordingly, the
Examiner's above-noted finding is not supported by a preponderance of the
evidence.
Under the Examiner's interpretation #2, (i) movement of portions of
the vein (at locations near Thornton's leaflets 38) towards each other causes
the leaflets to close the lumen, and, in addition, (ii) movement of the
portions of the vein near the leaflets substantially closes the lumen because
the lumen is narrower after such movement. Ans. 9-10; see also
Attachment 1.
We do not agree with the Examiner on these points. First, claim 1
requires that "opposing portions of the vein wall substantially close a
lumen," not that the opposing portions of the vein wall cause something else
to close the lumen. Second, as is evident from Figures 14A-14C of
Thornton, the walls of the vein (excluding leaflets 3 8) do not substantially
close the lumen; rather, contact between leaflets 38 does. Accordingly, we
do not sustain the Examiner's rejection of claims 1-3, 5, 6, 10, and 18-20 as
anticipated by Thornton.
Re} ections (II and III)
The Examiner relies on each of Chu and Laufer for teaching structure
similar to the valve system taught by Thornton and relied upon in Rejection
(I). Final Act. 6-9; Ans. 11-13; see also Chu, Figs. 44--48; Laufer, Figs. 4--
7. Accordingly, Rejection (II), based on Chu, and Rejection (III), based on
10
Appeal2014-003470
Application 12/706,904
Laufer, suffer from the same deficiencies as Rejection (I), and we reverse
these rejections for the reasons discussed above with respect to Rejection (I).
Rejection (IV)
The Examiner's use of Armstrong does not remedy the deficiencies in
Rejection (I). See Final Act. 10. Accordingly, we do not sustain Rejection
(IV).
DECISION
The Examiner's rejection of claims 1-3, 5-8, 10, and 17-20 is
reversed.
REVERSED
11