Ex Parte Batiste et al

Patent Trial and Appeal Board

Sep 8, 2016

13212129 (P.T.A.B. Sep. 8, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/212, 129 08/17/2011
32856 7590 09/08/2016
WEIDE & MILLER, LTD,
7251 W. LAKE MEAD BL VD.
SUITE 530
LAS VEGAS, NV 89128
FIRST NAMED INVENTOR
Stanley Batiste
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.
VASOFL.0025P 5631
EXAMINER
SCHALL, MATTHEW WAYNE
ART UNIT PAPER NUMBER
3738
MAILDATE DELIVERY MODE
09/08/2016 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STANLEY BATISTE and STEVEN ACHSTEIN
Appeal2014-008583
Application 13/212,129
Technology Center 3700
Before JOHN C. KERINS, AMANDA F. WIEKER, and
SEAN P. O'HANLON, Administrative Patent Judges.
O'HANLON, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Stanley Batiste and Steven Achstein (Appellants) 1 appeal under 35
U.S.C. § 134 from the Examiner's decision rejecting claims 1-15, 22, and
23. 2 We have jurisdiction over this appeal under 35 U.S.C. § 6(b ).
SUMMARY OF DECISION
We AFFIRM-IN-PART.
1 According to Appellants, the real party in interest is Dr. Stanley Batiste.
App. Br. 2.
2 Claims 16-21 have been canceled. Id. at 38.
Appeal2014-008583
Application 13/212, 129
SUMMARY OF INVENTION
Appellants' disclosure "relates to vascular bypass grafts and, in
particular, to surgically implanted grafts which increase blood flow and
reduce clotting." Spec. i-f 2. Claim 1, reproduced below from page 35
(Claims Appendix) of the Appeal Brief, is illustrative of the claimed subject
matter:
1. A vascular connector comprising:
a primary graft stem fabricated from a substantially
hollow member, the primary graft stem having a first end and a
second end, the first end configured to connect to a first blood
vessel and define an interior passage that is external to the first
blood vessel for blood flow out of the first blood vessel,
through the interior passage of the primary graft stem and out
the second end, the second end configured to connect to the first
blood vessel; and
a venous outflow stem fabricated from a substantially
hollow member, the venous outflow stem connected to and
extending outward from an opening in the primary graft stem to
create a fluid passage from the interior passage of the
substantially hollow primary graft stem into the substantially
hollow venous outflow stem which is capable of diverting a
portion of the blood flow from the primary graft stem through
the venous outflow step to a second blood vessel.
Independent claims 8 and 22 are also directed to vascular connectors and
include similar limitations as in claim 1. App. Br. 36-37, 39.
REJECTION
Claims 1-15, 22, and 23 are rejected under 35 U.S.C. § 102(a) as
being anticipated by Greenberg (US 7,105,020 B2, issued Sept. 12, 2006).
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Appeal2014-008583
Application 13/212, 129
ANALYSIS
The Examiner rejects all of the pending claims by finding:
Greenberg discloses in Figures 8a-8d a hollow, integrally
formed, bioengineered, tapered primary graft (141) with one or
more angled ridges (143) and a smaller diameter secondary
graft ( 144) with one or more angled ridges and extending from
the central portion of the primary graft.
The graft is capable of being connected to blood vessels
at first and second ends.
Final Act. 2 (paragraph numbering omitted). Appellants argue each of the
pending claims separately, due to the "lack of detail" in the Examiner's
rejection. See App. Br. 19.
Claims 1-7
Regarding independent claim 1, Appellants argue that "[ t ]he
Greenberg prosthesis is not capable of connecting to a different vessel
because it is completely contained inside an aiie1y." App. Br. 23.
According to Appellants, the fact that the Greenberg prosthesis is intended
for use within a blood vessel results in structural differences that preclude it
from being capable of use externally to a blood vessel. Reply Br. 2-3. The
Examiner takes the "position that the device of Greenberg is capable of the
claimed use," noting that both Appellants' and Greenberg's devices are
"medical devices for the treatment of diseased blood vessels and can be
made from the same material" and asserting that "[ t ]here is nothing in the
disclosure of the various embodiments of Greenberg that would not allow
the device to be used in the manner specified in the present invention
(attached outside of a blood vessel instead of inside)." Ans. 2 (citing
Greenberg 7: 6 7).
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Application 13/212, 129
In the Reply Brief, Appellants state that "at the bottom of page 22 and
on page 23 [of the Appeal Brief], the Appellant[s] make[] clear which
structural differences are present between the claimed device and the
Greenberg device." Reply Br. 2. This section of the Appeal Brief, however,
recites language of claim 1 and contains a general allegation that the
Greenberg prosthesis is incapable of the recited use. App. Br. 22-23.
Similarly, Appellants present a summary of the Greenberg disclosure in
which they note differences in the intended uses of the Greenberg device and
Appellants' device. Id. at 20-22. Appellants do not, however, note any
structural differences between the devices that would preclude Greenberg
from being capable of the recited use, nor does our review of Greenberg and
Appellants' Specification reveal any such structural differences or any
discussion of Appellants' stem ends that make them "configured to connect
to" blood vessels. To the contrary, Appellants' and the Greenberg devices
are formed of similar materials and appear to be of similar size and shape.
See Spec. i-f 39, Figs. 3A--4B; see also Greenberg, 7:59-8: 1, 11 :60-66, Figs.
8a-8d, 15. Therefore, Appellants have failed to persuasively identify error
in the Examiner's findings or reasoning.
We are also unpersuaded by Appellants' assertion that "it is
impermissible for the Examiner to present a [35 U.S.C. §] 102 type
anticipation rejection relying on multiple different embodiments." Reply Br.
3. Here, although Greenberg refers to several embodiments, these
embodiments appear to be defined based on the prosthesis shape for the
location of intended use. The embodiment illustrated in Figures 8a-8d, for
example, "is designed for deployment into a right iliac artery and branching
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Appeal2014-008583
Application 13/212, 129
into the right hypogastric." Greenberg 11 :62---64. Although Greenberg
states that, in this embodiment, "[t]he prosthetic branch 144 is preferably
made of woven, crimped polyester" (id. at 11:65---66 (emphasis added)), we
find Greenberg's disclosure that "[t]he prosthetic trunk 42 is preferably
made of woven polyester [but] [t]he prosthetic trunk 42 and prosthetic
branch 44 can also be made of any other at least substantially biocompatible
material including such fabrics as ... polytetrafluorethylene (PTFE)" (id. at
7:59---67) to be a general description of the Greenberg prostheses and to
apply equally to the embodiment illustrated in Figures 8a-8d.
Thus, we sustain the Examiner's rejection of independent claim 1.
Claim 2 depends directly from claim 1 and further requires that "an
end of the primary graft stem is tapered." App. Br. 35 (Claims Appendix).
Appellants argue that the ends of the prosthesis illustrated in Greenberg
Figures 8a-8d are of constant diameter. Id. at 23-24; see also Reply Br. 3.
The Examiner finds that "[a] tapered end is disclosed in numerous
embodiments." Ans. 3 (citing Greenberg 8:53-54, Figs. 8a-8d).
Similarly to claim 1 discussed above, we find that Greenberg's
disclosure of a tapered trunk (see, e.g., Greenberg 8:53-54) to be a general
description and to apply equally to the embodiment illustrated in Figures 8a-
8d. Therefore, we sustain the Examiner's rejection of claim 2.
Claim 3 depends directly from claim 1 and further requires that "the
venous outflow stem is integrally formed with the vascular bypass graft."
App. Br. 35 (Claims Appendix). Appellants argue that Greenberg's
"prosthetic branch 144 is not integral or connected to the trunk 141" because
"Figure 8A ... shows a space or gap between the branch 144 and trunk
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Appeal2014-008583
Application 13/212, 129
141." App. Br. 24. The Examiner finds that "[t]his limitation is disclosed in
at least column 1, line 54 and shown in the various embodiments of the
figures." Ans. 3. Appellants reply by arguing that "the language found at
[Greenberg] column 1, line[] 54 is too generic to support the rejection" and
"the Greenberg device would not function for its intended purpose if the
primary graft were attached to (integrally formed with) the bypass graft
because it could not slide down into a separate artery." Reply Br. 4.
We are not persuaded by Appellants' arguments. Appellants appear
to be arguing that Greenberg does not disclose its branch being joined to its
trunk along peripheries thereof as illustrated in, for example, Appellants'
Figure 5E. Such a connection, however, is not required by claim 3. Rather,
as noted above, claim 3 merely requires that the venous outflow stem is
integrally formed with the vascular bypass graft. Greenberg discloses that
unitary prosthesis construction is well known (Greenberg 1 :54--55), and
Figures 8a-8d appear to show an end of branch 144 integrally formed with
trunk 141 at seam 146. We further note that this integral construction is
consistent with Appellants' embodiment illustrated in Figure 6A, which
illustrates only the end of the outflow stem being connected to the primary
member and which Appellants describe as having "a unitary construction
with the venous outflow limb 106 being integrally formed with the vascular
bypass graft 100." Spec. i-f 50.
Claim 4 depends directly from claim 1 and further requires "one or
more ridges at one or both ends of the primary graft stem." App. Br. 35
(Claims Appendix). Appellants argue that Greenberg element 143 is a stent
rather than a ridge. App. Br. 24. The Examiner finds that ridges are
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Appeal2014-008583
Application 13/212, 129
"disclosed in at least figure 13a." Ans. 3. Appellants respond by asserting
that "[t]he zig-zag lines at the top [of Figure 13a] are taught by the
Greenberg reference to be Z-Stents" and arguing that "the Examine[ r]
cannot pick and choose elements from different embodiments when making
a section 102 rejection." Reply Br. 4.
Similarly to claim 1 discussed above, we find Greenberg's disclosure
of a crimping (see, e.g., Greenberg 8:19--27, 13:63---65) to be a general
description and to apply equally to the embodiment illustrated in Figures 8a-
8d. As illustrated in, for example, Figure 13a, this crimping imparts a ridged
construction. Therefore, we sustain the Examiner's rejection of claim 4.
Claim 5 depends directly from claim 1 and further requires "one or
more angled ridges at an outflow end of the venous outflow stem." App. Br.
36 (Claims Appendix). The Examiner finds that "[t]he venous outflow stem
(144) [illustrated in Greenberg Figures 8a-8d] has angled ridges along its
entire length." Ans. 3. Appellants argue that because "the side profile
surface of element 144 is smooth," the branch of the prosthesis illustrated in
Greenberg Figures 8a-8d does not include ridges. Reply Br. 5.
We are not persuaded by Appellants' arguments. While Greenberg
Figures 8a-8d might not show a level of detail to illustrate all aspects of the
ridges in crimped branch 144, Greenberg discloses such crimping as
including projections, and other figures illustrate such crimping as including
ridges. See Greenberg 8:19--27, Fig. 13a.
Claim 6 depends directly from claim 1 and further requires that "the
vascular connector is lined with native vein, allograft, zenograft,
bioengineered or drug elution materials." App. Br. 36 (Claims Appendix).
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Application 13/212, 129
Appellants argue that this limitation is not disclosed within Greenberg. App.
Br. 25; see also Reply Br. 5. The Examiner finds that Greenberg discloses
forming the prosthesis of PTFE, which, the Examiner asserts, "is a
bioengineered material." Ans. 3 (citing Greenberg 7:67).
Appellants' conclusory arguments fail to apprise us of error in the
Examiner's findings or reasoning, and we therefore sustain the rejection of
claim 6.
Regarding the rejection of claim 7, Appellants do not make any other
substantive argument and instead rely on the dependency from claim 1. See
App. Br. 26; see also Reply Br. 5. Accordingly, for the same reasons as
discussed above, we also sustain the rejection of claim 7.
Claims 8-15
Independent claim 8 defines a vascular connector comprising, inter
alia, a prima1 y stem having first and second ends, the first stem configured
to accept a blood flow in the first end and out the second end, and a
secondary stem "extending from a wall of the primary stem to create a fluid
path from the primary stem to the secondary stem and then extend linearly in
a direction toward the first end of the primary stem" and "having an outflow
end configured to externally connect to a second vessel to thereby divert a
second portion of the blood flow into the primary stem to the second vessel."
App. Br. 36-37 (Claims Appendix). The Examiner finds that this "claim
simply requires the secondary stem to extend for at least a portion of its
length in a straight line towards the end of the primary stem," which "is
clearly shown in [Greenberg] figures 8a-8d, as well as numerous other
embodiments." Ans. 4. Appellants disagree, arguing, inter alia, that the
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Appeal2014-008583
Application 13/212, 129
claim requires that blood flow through the primary and secondary stems in
opposite directions and that the Greenberg prosthesis is not configured to
provide such flows. App. Br. 26-27.
We are persuaded by Appellants' arguments. Claim 8 defines the
primary stem first end as receiving blood flow and the primary stem second
end as outputting blood flow. The claim further requires the secondary stem
to extend from the primary stem towards the primary stem first end-that is,
towards the inlet end of the primary stem. Greenberg's prosthesis 140 is
only configured in this manner-that is, with branch 144 extending towards
the inlet of trunk 141-if the blood flow is directed oppositely than as
disclosed in Greenberg, namely upwardly with respect to Figures 8a-8d.
However, when arranging the Greenberg prosthesis in this manner, it is not
clear that "a fluid path from the primary stem to the secondary stem" would
be created or that any flow would be diverted through the secondary stem, as
required by claim 8, due to the orientation of branch 144 relative to trunk
141. In other words, the positioning of the opening of branch 144 180° from
the direction of flow through trunk 141, especially in conjunction with the
pressure decrease in the flow due to the widening of trunk 141 at the same
location, makes it unclear if any of the flow would be diverted through
branch 144. Moreover, the Examiner has failed to address these
requirements of claim 8.
Accordingly, for the foregoing reasons, we do not sustain the
Examiner's rejection of independent claim 8, or of claims 9-15, each of
which depends directly from claim 8, as being anticipated by Greenberg.
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Appeal2014-008583
Application 13/212, 129
Claims 22 and 23
Independent claim 22 defines a vascular connector comprising, inter
alia, a primary stem having first and second ends, the first stem configured
to accept a blood flow in the first end and out the second end, and a
secondary stem, the secondary stem "extending from a wall of the primary
stem at the second end of the primary stem to create a fluid path from the
second end of the primary stem to the secondary stem" and "having an
outflow end configured to connect to a second vessel to thereby divert a
second portion of the blood flow into the primary stem to the second vessel."
App. Br. 39 (Claims Appendix). Appellants argue, inter alia, that
Greenberg does not disclose the secondary stem extending from the second
end of the primary stem. App. Br. 32; see also Reply Br. 7. The Examiner
contends that "[ t ]his is disclosed in numerous embodiments, see for
example, [Greenberg] figures 12-15. The secondary stem is attached at or
near the end of the primary stem in each figure." Ans. 5.
We are persuaded by Appellants' arguments. Claim 22 defines the
primary stem first end as receiving blood flow and the primary stem second
end as outputting blood flow. The claim further requires the secondary stem
to extend from the primary stem at the second end-that is, from the outlet
end. Greenberg's prosthesis 140 is only configured in this manner-that is,
with branch 144 extending from an outlet end of trunk 141-if the blood
flow is directed oppositely than as disclosed in Greenberg, namely upwardly
with respect to Figures 8a-8d. However, when arranging the Greenberg
prosthesis in this manner, it is not clear that "a fluid path from the second
end of the primary stem to the secondary stem" would be created or that any
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Application 13/212, 129
flow would be diverted through the secondary stem, as required by claim 22,
due to the orientation of branch 144 relative to trunk 141. As discussed
above, such orientation makes it unclear if any of the flow would be diverted
through branch 144. Moreover, the Examiner has failed to address these
requirements of claim 22.
Accordingly, for the foregoing reasons, we do not sustain the
Examiner's rejection of independent claim 22, or of claim 23, which
depends directly from claim 22, as being anticipated by Greenberg.
DECISION
The Examiner's decision to reject claims 1-7 is affirmed.
The Examiner's decision to reject claims 8-15, 22, and 23 is reversed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED-IN-PART
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