Paul G. Mort et al.

Patent Trials and Appeals Board

Aug 15, 2019

14996164 - (D) (P.T.A.B. Aug. 15, 2019)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/996,164 01/14/2016 Paul G. Mort 1001.3837101 6319
11050 7590 08/15/2019
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
EXAMINER
BARIA, DINAH N
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
08/15/2019 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):
BSC.USPTO@stwiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte PAUL G. MORT and PAUL MANNION1
____________________

Appeal 2019-000654
Application 14/996,164
Technology Center 3700
____________________

Before DANIEL S. SONG, BRETT C. MARTIN, and
MICHAEL L. WOODS, Administrative Patent Judges.

SONG, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
The Appellant appeals under 35 U.S.C. § 134(a) from the Examiner’s
Final Office Action (“Final Act.”) rejecting claims 1–6, 9–15, 19, and 21–26
in the present application. We have jurisdiction under 35 U.S.C. §§ 6(b) and
134(a).
We Affirm-In-Part.

1 The Appellant is the Applicant, Boston Scientific SciMed, Inc., which is
identified as the real party in interest. Appeal Brief (“App. Br.”) 4.
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The claimed invention is directed to an implantable medical device.
Title. Claims 1, 12, and 21 are independent claims. Representative claims 1
and 21 read as follows:
1. An implantable medical device, comprising:
a stent having a covered portion and an uncovered portion;
wherein a proximal end of the covered portion is
releasably attached to a distal end of the uncovered portion;
a cover member disposed along the covered portion;
wherein the uncovered portion includes a release tab that
is designed to release the uncovered portion from the covered
portion, wherein the release tab is disposed at a proximal end of
the uncovered portion, wherein proximally pulling the release
tab detaches the uncovered portion of the stent from the covered
portion of the stent; and
a removal member coupled to the covered portion for
aiding in the removal of the covered portion from an implantation
site.

21. An implantable medical device, comprising:
a stent having a covered portion extending to a first end of
the stent, and an uncovered portion extending from the covered
portion to a second end of the stent;
wherein the uncovered portion of the stent is formed from
a single crocheted wire having a plurality of loops for allowing
tissue ingrowth therein;
a cover member disposed along the covered portion to
limit tissue ingrowth therein; and
a release tab located at a terminal end of the single
crocheted wire at the second end of the stent, wherein the single
crocheted wire forming the uncovered portion is configured to be
unraveled via proximally pulling the release tab to remove the
stent from a body lumen.
App. Br. 36, 38, Claims App’x. (emphases added).
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REJECTIONS2
The Examiner rejects various claims under 35 U.S.C. § 103 as
follows:
1. Claims 1–5, 9–13, 15, and 19 as obvious over Hartley (US
2004/0176832 A1, pub. Sept. 9, 2004), in view of Mattson (US
2012/0158122 A1, pub. June 21, 2012) and Ryan (US 2011/0087146 A1,
pub. Apr. 14, 2011). Final Act. 4.
2. Claims 6 and 14 as obvious over Hartley in view of Mattson,
Ryan, and Ducharme (US 2011/0245851 A1, pub. Oct. 6, 2011). Final Act.
10.
3. Claim 21 as obvious over Hartley in view of Mattson. Final
Act. 11.
4. Claims 22–26 as obvious over Hartley in view of Mattson and
Ryan. Final Act. 12.

ANALYSIS
Only those arguments actually made by the Appellant have been
considered in this decision. Arguments that the Appellant could have made
but chose not to make have not been considered and are deemed to be
waived. See 37 C.F.R. § 41.37(c)(1)(iv); In re Jung, 637 F.3d 1356, 1365–

2 The Examiner’s rejection of claims 21–26 under 35 U.S.C. § l 12(a) or 35
U.S.C. § 112 (pre-AIA), first paragraph (Final Act. 2–3), has been
withdrawn in the Advisory Action of February 12, 2018, which enters the
proposed amendment of the Appellant.
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66 (Fed. Cir. 2011); Ex parte Frye, 94 USPQ2d 1072, 1075–76 (BPAI 2010
(precedential)).

Rejection 1
The Examiner rejects claims 1–5, 9–13, 15, and 19 as obvious over
Hartley, in view of Mattson and Ryan. Final Act. 4. As to independent
claim 1 and dependent claims 3, 4, and 11, the Examiner finds that Hartley
discloses an implantable medical device substantially as claimed, but fails to
disclose
the uncovered portion including a single crocheted wire with a
release tab disposed at a proximal end of the uncovered portion,
wherein proximally pulling the release tab detaches the
uncovered portion of the stent from the covered portion of the
stent, and a removal member comprising a suture, coupled
to/disposed about the covered portion.
Final Act. 4, citing Hartley, ¶¶ 49, 56, 58; Figs. 5–7.
The Examiner relies on Mattson for disclosing a removable stent
formed from a crocheted, single wire, “the stent including a release tab (12)
at a proximal end (6) of the stent, which when proximally pulled unravels
the stent, in order to facilitate removal of the stent.” Final Act. 5, citing
Mattson ¶¶ 31, 35, 81, 83; Fig. 5. The Examiner further relies on Ryan for
disclosing “a removal member/suture loop coupled to a stent, wherein the
removal member/suture loop aids in the removal and/or repositioning of the
stent.” Final Act. 5, citing Ryan ¶ 126.
Based on the above findings, the Examiner concludes that it would
have been obvious to a person of ordinary skill in the art to have
implemented the medical device of Hartley
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to include a single crocheted wire, since doing so amounts to a
mere matter of substitution of one type of stent structure known
in the art for another type of stent structure known in the art;
and further for the stent of the uncovered portion to include a
release tab at the proximal end, which when proximally pulled
would unravel the uncovered stent portion, facilitating
removal/separation of the stent of the uncovered portion . . .
[and] to have a removal member/suture loop coupled
to/disposed about the covered portion . . . in order to aid in the
removal of the covered portion from an implantation site.
Final Act. 5–6.
The Examiner explains that
Hartley clearly states that covered portion (25) and an
uncovered portion can be attached/joined together by threads or
sutures . . . and the structure of sutures/thread allows for them
to be easily cut/severed, which would result in the two stent
portions being released/unattached; thus Hartley clearly teaches
the claimed parameter of the two stent portions being
“releasably attached to each other”.
Ans. 14, citing Hartley ¶¶ 56, 58.
The Appellant disagrees “with the characterization of the cited
covered portion being releasably attached to the cited uncovered portion by
virtue of threads or sutures that ‘can easily be cut.’” App. Br. 8. In
particular, the Appellant argues that cutting the threads or sutures to separate
the uncovered portion from the covered portion is not contemplated by
Hartley, and would render it unsatisfactory for its intended purpose of
deflating the false lumen via the uncovered portion. App. Br. 9. Further,
Appellant argues that
Appellants are unaware of any precedent that permits . . .
physical destruction of the original device (e.g., cutting the
connecting sutures of Hartley) as a purported capability to detach
two elements from each other, where the cited reference does not
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teach separating the two elements in this manner, and in
particular, where the cited reference teaches both elements are
required for proper function of the device in resolving the
problem being addressed (e.g., aortic dissection).
App. Br. 10.
We agree with the Appellant. The rejection presumes that it would
have been obvious and desirable to allow separation of the uncovered
portion from the covered portion without adequate findings or reasoning in
support. However, as the Appellant argues,
None of the cited paragraphs of Hartley teach or suggest that the
stents are releasably attached to each other, or are intended to be
detachable from each other. Instead, Hartley appears to teach
that the stents are intended and/or desired to remain attached to
each other for proper and complete function of the disclosed
prostheses.
App. Br. 9; see also id. at 10 (“there is no reason, explicit, implicit, or
obvious, to separate the stents from each other or to even propose doing
so.”).
Although the rejection is premised on cutting sutures of Hartley that
secures its uncovered portion to the covered portion, we fail to discern any
teachings in the art of record, and the Examiner has failed to provide a
reason with rational underpinnings, as to why a person of ordinary skill in
the art would have found it obvious to cut the sutures of Hartley to separate
its uncovered and covered portions from each other. In that regard, in our
view, interpreting the limitation “releasably attached” to encompass such
cutting/destruction of the suture that secures the uncovered and covered
portions of Hartley is unreasonably broad.
The Examiner provides an alternative explanation, stating that the
rejection “should be looked at as a whole” wherein
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the uncovered crocheted stent, taught by Mattson, is ‘releasably
attached’ to the stent of the covered portion Hartley, since when
the release tab of the uncovered crocheted stent is pulled, the
stent would unravel into a single wire and could be pulled
through the suture/thread connection to removing/release it
from the covered portion.
Ans. 14.
However, this alternative explanation of the Examiner is speculative
because whether the wire can be pulled through the suture connections
would depend on numerous factors, including the number of sutures used to
secure the covered portion to the wire, how tightly the sutures are secured to
the wire, the rigidity of the wire and its bends, the friction between the
sutures and wire, etc. At minimum, considering the number of sutures in
Hartley securing the uncovered portion to the covered portion, the
Examiner’s assertion is speculative and insufficient to support the rejection.
The Examiner’s application of Ryan does not address the above-noted
deficiency in the combination of Hartley and Mattson. Therefore, in view of
the above considerations, we reverse the Examiner’s rejection of claim 1,
and the rejection of claims 2–5 and 9–11 that ultimately depend from claim
1.
Independent claim 12 recites a “braided portion [that] is releasably
attached to a first end region . . . wherein pulling the release tab unravels the
crocheted portion of the stent and detaches the crocheted portion of the stent
from the braided portion of the stent.” Hence, independent claim 12
includes limitations that are substantively similar to independent claim 1
discussed above. Thus, we also reverse the rejection of claim 12, and claims
13, 15, and 19 that depend therefrom. The remaining arguments between the
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Examiner and the Appellant as to the other limitations of the various claims
subject to this rejection are moot.

Rejection 2
Claims 6 and 14 depend from claims 1 and 12 respectively, and stand
rejected as obvious over Hartley in view of Mattson, Ryan, and Ducharme.
Final Act. 10. However, the Examiner’s application of Ducharme does not
remedy the deficiency discussed above relative to the rejection of claims 1
and 12. Thus, this rejection is reversed.

Rejection 3
The Examiner rejects independent claim 21 as obvious over Hartley in
view of Mattson, relying on findings set forth in Rejection 1. Final Act. 11–
12. The Appellant relies on arguments substantively similar to those
proffered relative to claim 1. App. Br. 27. In that regard, the Appellant
again argues that Hartley does not “teach or suggest that the stents are
releasably attached to each other, or are intended to be detachable from each
other.” App. Br. 29–30. However, unlike independent claims 1 and 12,
independent claim 21 does not recite that the uncovered portion is releasably
attached to the covered portion, or recite detachment of these portions from
each other. Therefore, this line of argument is unpersuasive.
The Appellant also argues that Hartley does not “teach or suggest that
the covered stent of Hartley (whether modified by Mattson or not) is
designed to limit tissue ingrowth therein,” or that the uncovered portion
allows tissue ingrowth as recited by claim 21. App. Br. 27. This argument
is also unpersuasive. The Appellant’s Specification does not attribute
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limiting tissue ingrowth, or allowing for tissue ingrowth, to anything other
than that the portions are covered or uncovered. Spec. p. 6, ll. 12–18. We
agree with the Examiner that
the crocheted stent, as taught by Mattson, has a physical
structure which would permit for tissue ingrowth, due to the
plurality of loops/open cell structure of the stent, and the fact
that there is nothing disclosed in either Hartley or Mattson
which would prevent the physical structure of the stent from
permitting tissue ingrowth; and the physical structure of the
cover member/graft material (36), as taught by Hartley, would
inherently “reduce tissue ingrowth” along the covered portion
of the stent compared to the uncovered portion, since it acts as a
physical barrier between the stent of the covered portion and
tissue, resulting in reduced/less tissue ingrowth at the stent
portion that is covered than at the stent portion that is not
covered.
Ans. 22.
The Appellant also argues that Hartley discloses a permanent implant
while Mattson is a temporary implant, and thus, a person of ordinary skill
would not have combined Mattson with Hartley. App. Br. 28; see also App.
Br. 11. In particular, the Appellant argues that “Hartley discloses barbs to
‘securely fix the covered portion 25 of the prosthesis.’” App. Br. 11,
quoting Hartley ¶ 48. However, this argument is unpersuasive because
contrary to the Appellant’s assertion, Hartley does not disclose that its
implant is permanent, and discloses that the implant may be provided with
“barbs,” not that the barbs are required. Hartley ¶ 10 (“prosthesis may
include barbs”); ¶ 15 (“There may be included barbs”); compare
independent claim 1 (does not recite “barb”), with claim 7 dependent on
claim 1 (recites “includes barbs”). As the Appellant notes, Mattson
explicitly discloses reasons to make such implants removable. App. Br. 28,
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citing Mattson ¶¶ 5, 8. Accordingly, we agree with the Examiner’s
conclusion that it would have been obvious to one of ordinary skill in the art
“to change the permanently implanted medical device of Hartley into a
temporary/removable device” to avoid the dangers noted in Mattson. Ans.
16.
The Appellant further argues that even if the implant of Hartley is
made to be removable, a person of ordinary skill in the art would “replace
the entire stent of Hartley with the crocheted stent of Mattson,” and that
Mattson does not “teach or suggest only a portion of the stent should be
crocheted and/or removable.” Reply Br. 2–3. However, the Appellant’s
argument ignores the function of the covered portion in Hartley’s implant.
Hartley ¶ 48 (“covered portion 25 of the prosthesis covering the rupture 7
and essentially closing it off so that blood can no longer flow into the false
lumen 10.”); Fig. 4. Moreover, as discussed above, claim 21 does not recite
that the uncovered portion is detached from the covered portion.
Therefore, in view of the above considerations, we affirm the
Examiner’s rejection of claim 21.

Rejection 4
Claims 22–26 ultimately depend from claim 21, and stand rejected as
obvious over Hartley in view of Mattson and Ryan. Final Act. 12.
Claim 22
Claim 22 depends from claim 21, and recites that “the covered portion
comprises a plurality of braided wires forming a braided tubular member.”
App. Br. 38, Claims App’x. The Examiner rejects claim 22 finding that
“Ryan teaches that it is well known in the art for stents to have different
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forms/types, including being a braided stent.” Final Act. 12, citing Ryan
¶¶ 117–118; Figure 25. The Examiner concludes that it would have been
obvious to a person of ordinary skill in the art to “determine an appropriate
type of stent structure for the stent of the covered portion, of the medical
device of Hartley in view of Mattson, including being braided, as claimed;
since doing so merely amounts to substituting one known type of stent
structure for another known type of stent structure.” Final Act. 12–13.
The Appellant unpersuasively relies on the arguments submitted with
respect to claim 21, and dependency thereon, for patentability of claim 22.
App. Br. 31. The Appellant also argues that “no deficiencies are set forth for
the covered stent of Hartley. Therefore, there is no reason for a PHOSITA
to look toward the disclosure of Ryan for a modification to the covered stent
of Hartley, except to provide a feature or limitation of the claim that is not
disclosed by Hartley.” App. Br. 31. However, we agree with the Examiner
that claim 22 would have been obvious to one of ordinary skill in the art
considering that “when a patent claims a structure already known in the prior
art that is altered by the mere substitution of one element for another known
in the field, the combination must do more than yield a predictable result.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). The Appellant’s
argument is tantamount to requiring explicit teaching or suggestion, but this
is not the law. KSR, 550 U.S. at 418–19 (“the analysis need not seek out
precise teachings directed to the specific subject matter of the challenged
claim.”).
Therefore, we affirm the Examiner’s rejection of claim 22.
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Claims 23–26
Claim 23 depends from claim 22, and recites that “covered portion is
releasably attached to the uncovered portion.” App. Br. 38, Claims App’x.
Accordingly, because claim 23 includes limitations similar to independent
claim 1, we reverse this rejection of this claim for reasons already discussed
above. In addition, claims 24–26 depend from claim 23. Accordingly, the
rejection of these claims is reversed as well.

CONCLUSIONS
1. Rejection 1 of claims 1–5, 9–13, 15, and 19 is Reversed.
2. Rejection 2 of claims 6 and 14 is Reversed.
3. Rejection 3 of claim 21 is Affirmed.
4. Rejection 4 of claims 22–26 is:
a. Affirmed as to claim 22; and
b. Reversed as to claim 23–26.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED-IN-PART