Ex Parte Mirizzi et al

Patent Trial and Appeal Board

Mar 29, 2017

12642717 (P.T.A.B. Mar. 29, 2017)

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.
12/642,717 12/18/2009 Michael S. Mirizzi H-KN-01671 (1) 3090
77218 7590 03/31/2017
MeHtrnnio Vasionlar - APV Division
EXAMINER
c/o IP Legal Department
3576 Unocal Place
LOUIS, RICHARD G
Santa Rosa, CA 95403 ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
03/31/2017 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. docketingap v @ medtronic .com
medtronic_apv_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL S. MIRIZZI, HALIL I. KARABEY,
MIRANDA M. RAY, and WILLIAM N. BOENIG
Appeal 2014-007021
Application 12/642,717
Technology Center 3700
Before KEN B. BARRETT, EDWARD A. BROWN, and
GEORGE R. HOSKINS, Administrative Patent Judges.
HOSKINS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Michael S. Mirizzi et al. (“Appellants”)1 appeal under 35 U.S.C.
§ 134 from the Examiner’s decision rejecting claims 1, 2, 4—10, and 12—16
under 35 U.S.C. § 103(a) as unpatentable over Mirizzi
(US 2006/0229669 Al, pub. Oct. 12, 2006)2, Fernandez (US 5,897,497, iss.
Apr. 27, 1999), and Sepetka (US 2006/0116713 Al, pub. June 1, 2006). The
Board has jurisdiction over the appeal under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 The Appeal Brief identifies Covidien LP as the real party in interest.
Appeal Br. 1.
2 Michael S. Mirizzi is the lead inventor in the application presently on
appeal, and in the Mirizzi prior art reference.
Appeal 2014-007021
Application 12/642,717
CLAIMED SUBJECT MATTER
Claims 1 and 9 are independent. Claim 1 illustrates the claimed
subject matter, and it recites:
1. An apparatus for introducing an implant into a hollow
anatomical structure, the apparatus comprising:
a storage unit having an exit opening and defining a
chamber in communication with the exit opening;
an elongate, self-expanding vascular implant having an
expanded condition and stored within the chamber in the
expanded condition, proximal of the exit opening; and
a pushrod having a distal end aligned with and proximal
of the exit opening;
wherein the pushrod is pre-assembled to a distal end of the
implant;
further comprising an introducer sheath distal of the exit
opening; and
a guide proximal of the exit opening for facilitating
compression of the implant as the pushrod is advanced toward
and through the exit opening and into the introducer sheath.
Appeal Br. 18 (Claims App.) (emphases added).
ANALYSIS
Claims 1 and 9
In rejecting claim 1, the Examiner finds Mirizzi discloses an apparatus
for introducing an implant into a hollow anatomical structure, including each
and every limitation of the claim, except the “introducer sheath.” Final
Act. 2—3. The Examiner cites Fernandez as disclosing an introducer sheath,
and determines it would have been obvious to couple Fernandez’s introducer
sheath to Mirizzi’s apparatus to “guide the implant to a desired location
with[in] a patient’s body.” Id. at 3^4. Appellants do not challenge the
Examiner’s reliance on Fernandez in any respect. See Appeal Br. 3—12. We
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Application 12/642,717
therefore need not address Fernandez any further. See 37 C.F.R.
§ 41.37(c)(l)(iv) (“any arguments or authorities not included in the appeal
brief will be refused consideration by the Board for purposes of the present
appeal”).
The Examiner, “in the alternative” to Mirizzi disclosing storing an
implant in an expanded condition as recited in claim 1, relies on Sepetka as
disclosing “chambers configured to store occlusive implants in
uncompressed state are known.” Final Act. 4. For the reasons provided
below, we determine the Examiner does not err in finding Mirizzi discloses
storing an implant in an expanded condition, so we need not address the
Examiner’s alternative reliance on Sepetka any further.
As pertinent to Appellants’ arguments on appeal, the Examiner finds
Mirizzi discloses an apparatus which stores an implant within a storage unit
chamber in an expanded condition. Final Act. 2—3, 9—20 (citing Mirizzi,
Figs. 24—26,11 12, 116, 117, 177, 187-190). Figures 2A-26 of Mirizzi
(hereafter “Cited Embodiment”)3 are reproduced below:
232
3 See Final Act. 9—20 (repeatedly emphasizing the Examiner’s reliance on
the embodiment of Figures 24—26 in Mirizzi).
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Application 12/642,717
232
firgJtf
This Cited Embodiment of Mirizzi is a “continuous feed” system for
delivering fibrous mass structure 210 out of sheath 232 and into a hollow
anatomical structure (not shown specifically in Figures 24—26). Mirizzi
11 68, 188. Figure 24 shows, prior to the delivery, fork-shaped pusher
head 242 of reciprocating member 230 engages a distal end of fibrous mass
structure 210. Id. 1188. Figure 25 shows member 230 being displaced
distally to force the distal end of fibrous mass structure 210 past claws 260
of sheath 232, into the hollow anatomical structure. Id. Figure 26 shows
reciprocating member 230 is then retracted, and disengaged from fibrous
mass structure 210, with claws 260 preventing reverse movement of
structure 210 back into sheath 232. Id. Reciprocating member 230 is then
displaced distally again to force more of fibrous mass structure 210 out of
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Application 12/642,717
sheath 232 into the hollow anatomical structure, in a repeating cycle until the
desired quantity of structure 210 is delivered. Id.
The Examiner finds fibrous mass structure 210 is an “implant” stored
in sheath 232 in an “expanded condition,” as recited in claim 1. Final
Act. 2—3. In support, the Examiner reasons implant 210 is “interchangeable
with the implants discussed elsewhere” in Mirizzi, which are described as
having “an expanded version . . . similar in appearance to” implant 210 as it
is stored within sheath 232. Id. at 3, 15. The Examiner particularly relies on
Mirizzi’s Figure 2A, showing implant 10 comprising fibrous mass
structure 12 in an “expanded” configuration, versus Mirizzi’s Figure 2C,
showing the same implant 10 in a “compressed” configuration. Final Act. 3,
15—16; Ans. 11; see Mirizzi 39, 41, 101, 116. The Examiner further finds
claws 260 “facilitate] compression of the implant as the pushrod [230] is
advanced toward and through the [exit] opening” of sheath 232. Final
Act. 3.
Appellants argue “the Examiner has not shown where Mirizzi
discloses that the implant is stored within the device in an expanded
condition.” Appeal Br. 3. Appellants contend the Mirizzi disclosure related
to the Cited Embodiment fails to reflect implant 210 being stored in an
expanded state within sheath 232. Id. at 7—8 (citing Mirizzi, Figs. 24—26,
1188). Appellants particularly “submit that Figures 24—26 show a
simplified version of the fibrous mass structure 210 wherein only a few
strands of the structure are shown for clarity.” Id. at 8; Reply Br. 4.
Appellants also point to Figure 27C as demonstrating implant 210 is in a
compressed state when stored within sheath 232. Appeal Br. 5. In
Appellants’ view, Mirizzi discloses several other embodiments in which an
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Application 12/642,717
implant is stored in a compressed state before being deployed to self-expand
to an expanded state within a hollow anatomical structure, and a proper
reading of Mirizzi’s disclosure as a whole indicates that is also how the
Cited Embodiment operates. Id. at 3—7, 9-12 (citing Mirizzi || 12, 30, 112—
117); Reply Br. 4—6. Thus, Appellants contend the Examiner errs in
“carv[ing] out” the Cited Embodiment “as somehow having no relation to
the other embodiments” of Mirizzi. Id.
The Examiner responds that the Cited Embodiment is pertinently
distinguished from the other Mirizzi embodiments relied upon by
Appellants, because it is “a continuous feed mechanism,” whereas the other
embodiments all “refer to using a delivery catheter.” Final Act. 10—11
(discussing Mirizzi || 113—114), 13—14 (discussing Mirizzi || 30, 115—
116). The Examiner finds Mirizzi’s written description of the Cited
Embodiment, unlike the descriptions of other embodiments relied upon by
Appellants, “does not refer to a compressed state, treatment state, or
[sheath 232] having an inside diameter of” any specific size. Id. at 9-10
(discussing Mirizzi 130), 11—13 (discussing Mirizzi || 115—116), 14.
According to the Examiner, Figures 24—26 illustrate an “axial space between
the fibers” in the Cited Embodiment, thereby suggesting a longitudinally
expanded condition within sheath 232. Id. at 15, 16; Ans. 11. The Examiner
further determines Figures 24—26 “do not appear [to] show any force on the
implant while it remains within the outer sheath 232” (Final Act. 18), and
Mirizzi paragraph 116 indicates its implants tend towards an expanded state
in the absence of external forces {id. at 18—19; Ans. 11). The Examiner
concludes Figures 24—26 do not illustrate a mere “simplified version” of
implant 210, because Mirizzi indicates its fibrous implants “can include one
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or more strands 14 of fiber material,” consistent with the “few strands”
shown in Figures 24—26. Final Act. 14 (quoting Mirizzi | 117). The
Examiner further determines Figure 27C is not probative of how implant 210
is stored within sheath 232, because it shows only exterior views of the
device. Ans. 13.
In reply, Appellants contend Mirizzi discloses sheath 232 as having
the same size as catheter 16 used in other embodiments—that is, 8 French or
less. Reply Br. 4—5. This is so, according to Appellants, because sheath 232
and catheter 16 are used for the same purpose of delivering an implant into a
hollow anatomical structure. Id. Appellants further rely on several
statements in Mirizzi that its implants are compressed when fitted into a
cylindrical tube having an inside diameter of 8 French or less, and point out
sheath 232 is a cylindrical tube. Id. at 5—6 (citing Mirizzi || 29, 30, 115).
We first conclude that the Cited Embodiment in Mirizzi is materially
different from the other embodiments cited by Appellants, in that the Cited
Embodiment is a continuous feed delivery mechanism, and the others are
not. See Mirizzi || 177, 179, 188. The continuous feed delivery mechanism
delivers an “elongate” fibrous mass structure 210, which “can have an
uncompressed length between about 1 m and about 30 m,” and then
compresses structure 210 within the hollow anatomical structure “to occupy
a substantially shorter length and smaller volume than in a loose
uncompressed state.” Id. 1179 (emphases added). The continuous feed
delivery mechanism thereby “allow[s] substantially larger veins and/or
longer sections of a hollow anatomical structure to be occluded,” in
comparison to the other embodiments cited by Appellants. Id. 1178
(emphases added); cf. id. Figs. 2E—2G, Tflf 112—114 (relatively shorter
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Application 12/642,717
implant 10 is pushed from behind by pushrod 18, in one pushing step, for
delivery into hollow anatomical structure 20). Thus, the various descriptions
of the other embodiments cited by Appellants — while not irrelevant to the
Cited Embodiment — are not as pertinent to the Cited Embodiment as
Appellants contend. In particular, the fact that in the other embodiments
“implant 10 preferably takes on a compressed configuration” when in a
delivery sheath (id. ]f]f 112—113) has little relevance to whether the implant
is compressed within the delivery sheath of the Cited Embodiment. Id.
1178 (continuous feed mechanisms are suitable to occlude “substantially
larger veins”).
We next agree with the Examiner that Mirizzi’s Figures 24—26
illustrate fibrous mass structure implant 210 in an “expanded condition,” as
recited in claim 1. This finding is supported by the significant spacing
between the individual fibers inside sheath 232 as illustrated in the Figures,
and the fact that none of those fibers is illustrated as touching the interior
wall of sheath 232. The finding is supported further by the greater similarity
in appearance between implant 210 of Figures 24—26 and the expressly-
described “expanded” implant 10 of Figure 2C, versus the “compressed”
implant 10 of Figure 2C. Id. ]Hf 39, 41, 101. Appellants’ rebuttal that
Figures 24—26 show only “a simplified version of the fibrous mass
structure 210 wherein only a few strands of the structure are shown for
clarity” is not persuasive. See Appeal Br. 8; Reply Br. 4. As the Examiner
notes, Mirizzi indicates its fibrous implants “can include one or more
strands 14 of fiber material,” consistent with the “few strands” shown in
Figures 24—26. Final Act. 14 (quoting Mirizzi 1117).
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Application 12/642,717
The Examiner’s finding is supported moreover by Figure 25, which is
reproduced below with our annotations:
Figure 25 illustrates “pusher head 242 engaging] the distal end of the
fibrous mass structure 210 and forcing] it past the claws 260.” Mirizzi
1188. We have annotated the figure to identify three diameters of fibrous
mass structure 210: diameter D1 within sheath 232, diameter D2 between
claws 260, and diameter D3 outside of sheath 232. As can be seen, as
implant 210 is forced out of sheath 232, its initial diameter D1 is reduced to
D2 when it encounters claws 260, and the diameter then immediately
increases to diameter D3, which is larger than D2 but smaller than D1. This
illustration suggests fibrous mass structure 210 is in a fully expanded state at
Dl, because it is not touching the interior wall of sheath 232, and then
contracts to get past claws 260, and re-expands to substantially the initially
expanded state once it is free of claws 260.
Mirizzi’s Figure 27C is not to the contrary. As the Examiner notes,
that figure is limited to an exterior view of the apparatus, and therefore has
little probative valve as to the state of fibrous mass structure 210 within
sheath 232. Ans. 13. Moreover, the relatively increased width of fibrous
mass structure 210 outside of sheath 232, versus sheath 232 itself, as shown
in the highly schematic Figure 27C, could be due to the “scrunching” of
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Application 12/642,717
structure 210 outside of sheath 232 rather than self-expansion of
structure 210. See Mirizzi || 179, 190 (pistol grip handle of Figure 27C
“pack[s]” implant material into hollow anatomical structure, and “[mjanual
compression may also be used to keep the implant material from going
backward”).
For the foregoing reasons, we sustain the rejection of claim 1 as
unpatentable over Mirizzi, Fernandez, and Sepetka. Appellants present the
same arguments as to claim 9, which similarly to claim 1 recites “the
implant is stored within the chamber in the expanded condition.” Appeal
Br. 3—12, 19. We, therefore, likewise sustain the rejection of claim 9 as
unpatentable over Mirizzi, Fernandez, and Sepetka.
Claim 5
Claim 5 depends from claim 1 to specify that the chamber storing the
implant “is generally shaped like a ring.” Appeal Br. 18 (Claims App.).
Appellants’ Figures 26—30 illustrate an exemplary ring-shaped implant
storage chamber. See Spec. Tflf 10, 347—354.
The Examiner determines the storage chamber of the Cited
Embodiment in Mirizzi is not generally ring-shaped. Final Act. 4. The
Examiner cites Sepetka, paragraph 241, as establishing “chambers which
store implants in the shape of a ring in an uncompressed state are known.”
Id. According to the Examiner, it would have been obvious to configure the
storage chamber of the Cited Embodiment in Mirizzi as a ring, “because it
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Application 12/642,717
would only involve using a known technique to improve a similar device in
the same manner.” Id. at 5.4
Appellants argue making the storage chamber in Mirizzi to be ring-
shaped would frustrate the purpose of Mirizzi. Appeal Br. 12. Specifically,
Appellants contend Mirizzi’s sheath 232 must be advanced into a hollow
anatomical structure to deposit an implant into the structure, and shaping
sheath 232 as a ring would make such an insertion impossible. Id. at 12—13.
The Examiner responds that Appellants’ consideration of the Mirizzi
disclosure “is based purely on speculation and not evidence in the record,”
because “[njowhere in Mirizzi is there any discussion that the shape of the
outer sheath 232, or the chamber it creates, affects how the invention
operates.” Final Act. 23; Ans. 16—17. The Examiner further determines,
even if Appellants are “correct that a ring shape could not be inserted into a
hollow anatomical structure, that would only be true for the portion of the
storage unit which was inserted into the hollow anatomical structure.”
Ans. 17. The Examiner maintains Mirizzi’s storage unit chamber “could be
modified” to be ring-shaped “by incorporating the loading ring disclosed by
[Sepetka] into the proximal end of the outer sheath 232.” Id.
We are persuaded that the Examiner errs in failing to set forth an
articulated reasoning with rational underpinning to support the legal
conclusion of obviousness. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir.
2006) (cited with approval in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
4 An alternative theory of obviousness presented in the Final Office Action,
that “[cjhanges in shape are generally considered to be obvious to one of
ordinary skill in the art, absent a showing a particular configuration is
significant,” is withdrawn in the Answer. See Final Act. 4 (citing
In re Dailey, 357 F.2d 669 (CCPA 1966)); Ans. 11.
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418 (2007)). In particular, while asserting that incorporating a ring-shape
implant storage chamber would “improve” Mirizzi, the Examiner fails to
specify what such improvement(s) might be. Final Act. 5; Ans. 6, 16—20.
This conclusory analysis is insufficient to support an obviousness rejection.
The requisite reason or motivation in support of obviousness requires
something more than a finding that the prior art would have allowed for the
modification, or that the prior art could be combined — which is essentially
all that the Examiner has established here. See Personal Web Techs., LLC v.
Apple, Inc., 848 F.3d 987, 991-94 (Fed. Cir. 2017).
For the foregoing reasons, we do not sustain the rejection of claim 5
as unpatentable over Mirizzi, Fernandez, and Sepetka.
Claim 6
Claim 6 depends from claim 1 to recite “the pushrod is partially
located exteriorly of the storage unit to expose a length of the pushrod for
gripping and enters the storage unit near a distal end of the storage unit.”
Appeal Br. 18 (Claims App.).
The Examiner determines, in the Cited Embodiment of Mirizzi as
particularly shown in Figure 25, pushrod 230 is partially located exteriorly
of sheath 232. Final Act. 5. The Examiner further determines pushrod 230
enters sheath 232 near a distal end of sheath 232, when it is retraced into
sheath 232 after releasing an amount of fibrous material. Id.; Ans. 21.
Appellants argue Figure 25 of Mirizzi illustrates pushrod 230 “when
the fibrous mass structure 210 is being delivered at the treatment site within
a hollow anatomical structure.'1'’ Appeal Br. 15 (emphasis added).
Appellants contend pushrod 230 is not thereby “exposed ... for gripping” as
recited in claim 6 by virtue of being outside of sheath 232, because “it would
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be inaccessible to the operator.” Id.; Reply Br. 7. Appellants further
contend “Mirizzi is silent as to where” pushrod 230 enters sheath 232, so the
Examiner fails to establish pushrod 230 “enters the storage unit near a distal
end of the storage unit” as claimed. Appeal Br. 15—16.
The Examiner responds that the “gripping” limitation in claim 6 is a
functional limitation, and therefore requires only that Mirizzi be capable of
performing the claimed function. Ans. 20; see In re Schreiber, 128 F.3d
1473, 1478—79 (Fed. Cir. 1997) (when apparatus claim includes functional
language describing claimed structure, it is Examiner’s burden to establish
the correspondingly cited prior art structure is inherently capable of
performing the claimed function). The Examiner “maintain[s] Figure 25
teaches the push rod is capable of being exposed for being gripped, just as
recited in the claim, because Figure 25 shows an exposed portion of the push
rod extends beyond outer sheath 232 which can be gripped by hand.” Id.
We agree with the Examiner’s conclusion that the “gripping”
limitation in claim 6 is a functional limitation, which is satisfied by the Cited
Embodiment in Mirizzi if the apparatus is capable of performing the claimed
function. Further, claim 6 does not specify any particular condition(s) under
which the pushrod must be partially located exteriorly of the storage unit for
gripping. Under a broadest reasonable construction in light of Appellants’
Specification, it is sufficient to satisfy claim 6 if Mirizzi’s pushrod 230 can
be partially located exteriorly of sheath 232 for gripping when sheath 232 is
outside of a patient’s body. As suggested by Figure 25, this can in fact
occur. Further, the Examiner’s finding that pushrod 230 enters the storage
unit (i.e., sheath 232) near a distal end of the storage unit is supported by a
preponderance of the evidence. See Mirizzi, Figs. 24—26,1188.
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For the foregoing reasons, we sustain the rejection of claim 6 as
unpatentable over Mirizzi, Fernandez, and Sepetka.
Claims 2, 4, 7, 8, 10, and 12—16
Appellants do not present any additional argument for the
patentability of dependent claims 2, 4, 7, 8, 10, and 12—16. Appeal Br. 3—
16. We, therefore, sustain the rejection of these claims as unpatentable over
Mirizzi, Fernandez, and Sepetka.
DECISION
The rejection of claims 1, 2, 4—10, and 12—16 as unpatentable over
Mirizzi, Fernandez, and Sepetka is affirmed as to claims 1, 2, 4, 6—10, and
12—16, and reversed as to claim 5.
No time period for taking any subsequent action in connection with
this appeal maybe extended, under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED-IN-PART
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