Ex Parte Mackay

Patent Trials and Appeals Board

Mar 19, 2019

12105211 - (D) (P.T.A.B. Mar. 19, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/105,211 04/17/2008
133414 7590 03/21/2019
Faegre Baker Daniels - W.L. Gore
2200 Wells Fargo Center
90 South Seventh Street
Minneapolis, MN 55402-3901
FIRST NAMED INVENTOR
Allen B. Mackay
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.
MP/277 5312
EXAMINER
TON, MARTIN TRUYEN
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
03/21/2019 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):
patentdocketing@faegrebd.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ALLEN B. MACKAY
Appeal 2018-005521 1
Application 12/105,211 2
Technology Center 3700
Before MURRIEL E. CRAWFORD, KENNETH G. SCHOPPER, and
ROBERT J. SILVERMAN, Administrative Patent Judges.
SCHOPPER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the rejection of claims
16-33. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 Our Decision references the Appeal Brief ("Appeal Br.," filed Feb. 7,
2018), the Reply Brief ("Reply Br.," filed May 7, 2018), the Examiner's
Answer ("Ans.," mailed Mar. 7, 2018), and the Final Office Action ("Final
Act.," mailed Sept. 7, 2017).
2 According to Appellant, "W. L. GORE & ASSOCIATES, INC., the
assignee of record, is the real party in interest to this application and appeal."
Appeal Br. 2.
Appeal2018-005521
Application 12/105,211
BACKGROUND
According to Appellant, "[t]he present invention relates to apparatus
and methods for delivery of intraluminal devices such as stents, stent-grafts
or ultrasound arrays to a desired site." Spec. 1, 11. 6-8.
CLAIMS
Claims 16, 31, and 33 are the independent claims on appeal. Claims
16 and 33 are illustrative of the appealed claims and recites:
16. A catheter comprising a catheter shaft having a proximal
end and a distal end and at least one lumen extending at least
partially there between, and further having a flexible distal tip
located at the distal end of said catheter, said distal tip having a
length and having a longitudinally curved shape when no
external forces are applied, wherein said curved shape tapers
along the length of the distal tip and comprises a longitudinally
oriented concave side and an opposing, longitudinally oriented
convex side, said catheter further having a device contained by
a restraining system located near the distal tip, said restraining
system including a constraining sheath releasable by a pull line,
wherein the restraining system is mounted such that the pull
line exits the catheter shaft at a concave tapered surface of the
catheter shaft and extends toward the flexible distal tip and is
maintained substantially aligned with a longitudinally oriented
meridian of the concave side of the longitudinally curved shape
of the flexible distal tip.
33. A catheter comprising:
a catheter shaft having a proximal end and a distal end,
the catheter shaft having a central lumen and defining a central
longitudinal axis;
a tip secured to the distal end of the catheter shaft, the tip
being flexible and having a first end, a second end, and a central
longitudinal axis extending between the first and second ends,
the longitudinal axis of the tip defining an arcuate shape in the
unbiased state, the arcuate shape having a concave side and a
convex side; and
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Application 12/105,211
an intraluminal device secured to the catheter shaft in a
collapsed configuration by a restraining system, the
intraluminal device including a side branch port maintained in
longitudinal alignment with the convex side of the arcuate
shape defined by the longitudinal axis of the tip and the
restraining system exiting the central lumen in alignment with
the concave side of the arcuate shape defined by the
longitudinal axis of the tip and a releasable seam formed by the
restraining system.
Appeal Br. 13, 16.
REJECTIONS
1. The Examiner rejects claims 16-30 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement. 3
2. The Examiner rejects claims 16-25 and 28-33 under 35 U.S.C. § I03(a)
as unpatentable over Thornton4 in view of Greenberg, 5 Kim, 6 and Van
Schie.7
3. The Examiner rejects claims 26 and 27 under 35 U.S.C. § I03(a) as
unpatentable over Thornton in view of Greenberg, Kim, Van Schie, and
Gifford. 8
3 The Examiner has withdrawn the written description rejection with respect
to claims 31 and 32. See Ans. 2.
4 Thornton et al., US 6,551,350 Bl, iss. Apr. 22, 2003.
5 Greenberg et al., US 2004/0106974 Al, pub. June 3, 2004.
6 Kim et al., US 6,613,081 B2, iss. Sept. 2, 2003.
7 Van Schie et al., US 2003/0088305 Al, pub. May 8, 2003.
8 Gifford et al., US 6,383,171 Bl, pub. May 7, 2002.
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Application 12/105,211
DISCUSSION
Written Description
The Examiner finds that claims 16-30 lack written description support
based on the limitation "a concave tapered surface of the catheter shaft" in
independent claim 16. Final Act. 3--4. The Examiner finds:
However, a taper or an intermediate section having a curved
surface reducing a diameter of the catheter is not at all
mentioned within the [S]pecification. Although, Figures 3A-B
and Figure 4 may show a slight taper within the shaft, the
catheter shafts of Figures 6A[-]B do not, and further, given that
drawings are not to be interpreted as being drawn to scale, the
teachings within the [S]pecification do not meet the objective
standard of compliance with the written description requirement
because it fails to clearly convey to a person having ordinary
skill in the art that the inventor had possession of the claimed
invention at the time the application was filed.
Id. at 4.
Appellant contends that one skilled in the art would understand that
these claim limitations are shown in the Figures, in particular with respect to
Figure 3B. Appeal Br. 11. Appellant also asserts that Figure 6A discloses a
taper when compared with the prior art depicted in Figure 5. Id. at 11-12.
"Adequate written description means that the applicant, in the
specification, must 'convey with reasonable clarity to those skilled in the art
that, as of the filing date sought, he or she was in possession of the [ claimed]
invention.'" Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1379
(Fed. Cir. 2009) (citation omitted) (brackets in original). We agree with the
Examiner that the Specification and drawings as originally filed do not
convey with reasonable clarity that Appellant was in possession of the
claimed invention. The language of the claim requires that "the pull line
exits the catheter shaft at a concave tapered surface of the catheter shaft."
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Application 12/105,211
See Appeal Br. 13 (Claims App'x). We agree with the Examiner that this
limitation is not shown in the original Figures. In particular, where the pull
line 26 exits the catheter shaft in Figure 3B, the shaft is tapered but does not
appear to be curved such that one would understand that this section of the
shaft includes a concave surface.
Figure 3B, shown above, provides "a plan view of a restraining system
mounted on a catheter based delivery system." Spec. 5, 11. 5-6. And with
respect to Figure 6A, although a tapered section of the catheter is shown, this
tapered section does not appear to include any curvature indicating it is a
concave surface and the pull line 26 appears to exit the catheter shaft
proximal to this tapered section.
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Figure 6A, shown above, "is a plan view of the ... catheter-based delivery
system having a flexible, curved distal tip and a restraining system." Spec.
5, 11. 16-18.
Thus, we are not persuaded of error and we sustain the rejection of
claim 16 here. We also sustain the rejection of claims 17-30 based on their
dependency from claim 16.
Obviousness
Claims 16--30
With respect to independent claim 16, we are persuaded of error by
Appellant's argument that the Examiner has failed to establish that the art of
record renders the claim obvious. Appeal Br. 5-8.
In rejecting claim 16, the Examiner acknowledges that the art relied
upon does not teach "the pull line exiting the catheter shaft at a concave
tapered surface of the catheter." Final Act. 7. However, the Examiner finds
that "the [S]pecification does not mention tapered shape of the catheter shaft
at all, and does not even show the feature in Figures 6A[-]B of the
application." Id. And the Examiner concludes:
Therefore, given that the [S]pecification is silent as to any
criticality for the shape of the catheter shaft and that the
catheter shaft would perform equally well regardless of whether
it is tapered or not, it would be obvious to a person having
ordinary skill in the art at the time of invention to have the pull
line exit the catheter shaft at a concave tapered surface of the
catheter shaft as a matter of obvious design choice that would
yield predictable results.
Id. at 7-8. Further, in response to Appellant's arguments, the Examiner
states:
The taper as described in the claims is merely a change in shape
and a reduction of diameter of the catheter shaft that has not
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Application 12/105,211
been taught to have any particular advantages, and thus, would
be obvious to include into the proposed combination given the
device would perform equally as well regardless of the shape
and diameter of the portion at which the pull line exits from the
catheter shaft.
Ans. 4.
Without further explanation regarding the specific combination
proposed, we find that the Examiner has not adequately supported the
obviousness rejection. In particular, although a change in shape and size
may not, in certain circumstances, be more than a design choice, the
Examiner has not established that such is the case here, because the
Examiner does not adequately explain why the modification of the art
"would yield predictable results" or why the claimed structure would
"perform equally as well" as the structure depicted in the art.
As best we can tell on the record before us, the Examiner is proposing
a modification of Thornton's element 148 such that lead 132 would exit
element 148 at a tapered concave surface, as required by the claim.
However, Thornton describes elements 148 and 150 as barriers positioned
around delivery catheter 136 to restrict movement of a stent graft. See
Thornton, col. 15, 1. 65---col. 16, 1. 7; see also id. at Fig. 9A. Thornton does
not describe a specific structure for the barrier elements, but we agree with
Appellant that they appear to be convex shapes. Id. at Fig. 9 A. Given this
depicted shape and the described function, it is not clear, without further
explanation, how the Examiner proposes to modify these elements to arrive
at the claimed structure with a reasonable expectation of success and such
that Thornton's device would perform equally well. For example, it is not
clear to us that one of ordinary skill in the art would understand that
substituting a concave tapered shape for Thornton's convex shape would
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perform equally well, i.e. such that movement of the stent graft is adequately
restricted as described in Thornton.
Based on the foregoing, we are persuaded of error in the rejection of
claim 16 as obvious. Accordingly, we do not sustain the rejection of claim
16 here. We also do not sustain the rejection of claims 17-25 and 28-30,
which depend from claim 16. Further, the Examiner's reliance on Gifford
with respect to claims 26 and 27 does not cure the deficiency in the rejection
of claim 16, and thus, we also do not sustain the obviousness rejection of
claims 26 and 27.
Claims 31 and 32
We are also persuaded of error with respect to the rejection of claim
31. Claim 31 is directed to a catheter including a catheter shaft with an
intermediate section having "a curved surface reducing a diameter of the
catheter shaft at the intermediate section." Appeal Br. 15 (Claims App'x).
The Examiner acknowledges that the art of record does not disclose a
catheter with an intermediate section as required by the claim. See Final
Act. 9-12. However, for reasons similar to those described above with
respect to claim 16, the Examiner finds that the shape of the intermediate
portion of the catheter is "a matter of obvious design choice that would yield
predictable results." Id. at 12; see also Ans. 3-5. As with claim 16, we find
that the Examiner has not established that any modification of the art would
"yield predictable results" or "perform equally as well" as the unmodified
art. As discussed above, Thornton provides two barriers 148 and 150 that
restrict movement of a stent graft along the catheter. See Thornton, col. 15,
1. 65---col. 16, 1. 7; see also id. at Fig. 9 A. Without further explanation, it is
not clear that modifying Thornton's barrier element as required by the claim,
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Application 12/105,211
i.e. such that it reduces the diameter of the catheter 136, would perform the
function of restraining the stent graft along the catheter equally as well as the
configuration already disclosed by Thornton. In particular, such a reduction
in the diameter of the catheter would appear to allow for greater movement
of the stent graft along the catheter shaft. Thus, it is not clear to us that one
of ordinary skill in the art would understand that modifying the art as
proposed would "perform equally well," and thus, we are persuaded of error
in the Examiner's conclusion. Accordingly, we do not sustain the rejection
of claim 31. For the same reasons, we do not sustain the rejection of
dependent claim 3 2.
Claim 33
With respect to claim 33, the Examiner finds that Thornton teaches a
catheter including a shaft, a distal tip, a release line that exits the catheter
shaft toward the tip, a constraining sheath that defines a seam, the release
line including a pull line coupling the sheath together along the seam, and a
side branch port maintained on the same side as the release line. Final Act.
9-10. The Examiner acknowledges that Thornton does not teach the tip
defining an arcuate shape and the release line secured in longitudinal
alignment with concave side of the arcuate shape. Id. at 10. However, the
Examiner finds that these elements are taught by or obvious in view of
Greenberg, Kim, and Van Schie. Id. at 10-12.
As discussed below, we are not persuaded of error by Appellant's
argument.
Appellant first argues that "[t]he cited references are not alleged as
teaching a restraining system exiting the central lumen in alignment with the
concave side of the arcuate shape defined by the longitudinal axis of the tip
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and a releasable seam formed by the restraining system" and that "[ n Jone of
the cited references teach a release line or a restraining system as is
described by the claims, the cited references fail to teach the claim
limitations as alleged." Appeal Br. 8-9. In support, Appellant asserts that
Thornton does not "teach a restraining system that exists exiting a catheter
shaft in alignment with the concave side of the arcuate shape defined by the
longitudinal axis of the tip and a releasable seam formed by the restraining
system." Id. at 9. We are not persuaded by the general allegation, without
further explanation, that the art of record does not teach the structure of
claim 33, and we are not persuaded by Appellant's argument against
Thornton individually. The Examiner addresses each element of the claim
in the rejection and does not rely on Thornton alone as teaching the
configuration of the restraining system, in contrast to what Appellant's
argument suggests.
Appellant also argues that the Examiner erred because the "only basis
for alleging obviousness is the Appellant's [S]pecification" and that the
Examiner's conclusions can only otherwise be supported by official notice,
which the Examiner has failed to establish. Appeal Br. 9-10. However, to
the extent this argument is related to the Examiner's reliance on design
choice as the reason for the conclusion of obviousness, we are not persuaded
with respect to claim 33. Specifically, the Examiner's reliance on design
choice relates to the tapered shape of the catheter shaft, which is not an issue
in claim 33. See Final Act. 11-12; see also Appeal Br. 14. With respect to
each of the elements of claim 33, the Examiner relies on the art of record as
teaching the claimed elements or provides a reason from the art for the
proposed combination. For example, the Examiner concludes that aligning
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the release line as it exits the catheter with the seam and the concave portion
of the arcuate tip would have been obvious in order "to allow for a user to
further curve the stent graft along the curvature of the thoracic arch in the
same direction as the curvature of the nosecone while also deploying it."
Final Act. 11 (citing Thornton, Fig. 9; Van Schie ,r 25); see also Ans. 5---6.
Appellant does not address the Examiner's specific findings or conclusions
with respect to this claim.
Based on the foregoing, we are not persuaded of error in the rejection
of claim 33. Accordingly, we sustain the rejection of claim 33.
CONCLUSION
We AFFIRM the rejection of claims 16-30 under 35 U.S.C. § 112,
first paragraph. We AFFIRM the rejection of claim 33 as obvious. We
REVERSE the rejections of claims 16-32 as obvious.
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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