Ex Parte DIVINO et al

Patent Trials and Appeals Board

Jun 5, 2019

14079590 - (D) (P.T.A.B. Jun. 5, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/079,590
137574 7590
Medtronic
826 Coal Creek Circle
Louisville, CO 80027
11/13/2013
06/07/2019
FIRST NAMED INVENTOR
Vincent DIVINO
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.
H-KN-02819US1 7318
EXAMINER
DORNBUSCH, DIANNE
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
06/07/2019 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):
rs. patents. two@medtronic.com
docketing@fortemip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte VINCENT DIVINIO, EARL FREDERICK BARDSLEY,
RICHARD RHEE, MADHUR ARUNRAO KADAM, and JULIE KULAK1
Appeal2018-000959
Application 14/079,590
Technology Center 3700
Before JAMES P. CALVE, MICHELLE R. OSINSKI, and
WILLIAM A. CAPP, Administrative Patent Judges.
OSINSKI, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134(a) from the Examiner's
decision rejecting claims 1, 3, 4, 7-10, 23, and 25-30.2 We have jurisdiction
over the appeal under 35 U.S.C. § 6(b).
We AFFIRM.
1 Covidien LP ("Appellant") is the Applicant as provided in 37 C.F.R.
§ 1.46. "Covidien LP and its corporate owner, Medtronic plc" are identified
as real parties in interest. Appeal Br. 3.
2 Claims 2, 11-14, 24, and 31-34 are withdrawn, and claims 5, 6, 15-22,
and 35-45 are cancelled. Appeal Br. 26-29 (Claims App.).
Appeal2018-000959
Application 14/079,590
THE CLAIMED SUBJECT MATTER
Claims 1 and 23 are independent. Claim 1 is reproduced below.
1. A device for treatment of an aneurysm, comprising:
a foam component having first, second, and third sections, the
first section having a first average porosity of between about 1
µm and about 150 µm, the third section having a third average
porosity of between about 150 µm and about 300 µm, and the
second section having a second average porosity different from
the first average porosity and the third average porosity, the
component being expandable from a compressed configuration
to an expanded configuration when released into the aneurysm
from a catheter.
Miles
Mavani
EVIDENCE
US 2009/0112249 Al
US 2010/0228184 Al
THE REJECTION3
Apr. 30, 2009
Sept. 9, 2010
Claims 1, 3, 4, 7-10, 23, and 25-30 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Miles and Mavani. Final Act. 3-5.
OPINION
With respect to independent claim 1, the Examiner relies on Miles for
teaching, among other things, a foam component that has first and second
sections having different average porosities. Final Act. 4. The Examiner
also relies on Miles for teaching that the foam component further comprises
a third section having an average porosity different from the porosity of the
second section. Id. The Examiner acknowledges that although Miles
3 A rejection of claim 45 under 35 U.S.C. § 102(b) as anticipated by Miles
(Final Act. 3) has been withdrawn because claim 45 has been cancelled
(Ans. 2).
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Application 14/079,590
teaches that "each section can have different sizes of pores, ... Miles does
not specify the size of the pores." Id. at 5. Consequently, Miles does not
disclose that the first section specifically has an average porosity of between
about 1 µm and about 150 µm and that the third section specifically has an
average porosity of between about 150 µm and about 300 µm, as set forth in
claim 1.
With respect to independent claim 23, the Examiner relies on Miles
for teaching, among other things, a foam component that has a region of
variable average porosity. Id. at 4. Because Miles does not specify the size
of the pores (id. at 5), Miles does not disclose that at least a portion of the
region of variable average porosity is between about 1 µm to about 150 µm
or about 150 µm to about 300 µm, as set forth in claim 23.
The Examiner finds that Mavani teaches a porous foam plug in which
"the pore sizes vary from 5-1000 microns." Id. ( citing Mavani ,-J 91 ). The
Examiner concludes that it would have been obvious to have the pore sizes
in Miles be within the range of pore sizes specified in Mavani because (i)
Mavani teaches the general conditions of pore sizes for foam components;
and (ii) it would promote tissue ingrowth and greater angiogenesis, which, in
tum, may promote better wound healing. Id. As to the specific ranges of
pore sizes for the first section (i.e., between about 1 µm and about 150 µm)
and third section (i.e., between about 150 µm and about 300 µm) of claim 1
and the specific ranges of pore sizes for at least a portion of the region of
variable porosity (i.e., between about 1 µm to about 150 µm or about 150 µm
to about 300 µm) of claim 23, the Examiner concludes that it would have
been obvious to discover the optimum or workable ranges of pore sizes ( e.g.,
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Application 14/079,590
for tissue ingrowth and healing) for each section or region through routine
experimentation. Id.
Appellant argues that Miles does not disclose three foam sections with
different porosities, but merely provides "specific examples in which the
foam body has two different levels of porosity." Appeal Br. 11 (citing Miles
,-J 70). Miles discloses that "for a spherical configuration, the central region
of the foam body may include a different number of [pores] than the outer
regions of the foam body so as to manipulate the compactive and expansive
characteristics of the foam body." Miles ,-J 70. Miles then further discloses
that "[a]dditionally, or alternatively, one-half of the sphere may exhibit one
level of porosity while the other half exhibits a different level of porosity."
Id. ( emphasis added). Miles explicitly states that the exemplary
modifications to the portions of a spherical configuration are additive or
cumulative. Thus, Miles discloses a spherical foam body having a central
region of one porosity, a first half of an outer region having a second
porosity, and a second half of the outer region having a third porosity.
Consequently, we are not persuaded that the Examiner erred in finding that
Miles teaches first and second sections having different average porosities,
as well as a third section having an average porosity different from that of
the second section. See Final Act. 4.
Appellant also argues that "the Examiner's rationale for modifying
Miles' device to include the pore sizes disclosed in Mavani (i.e., to promote
angiogenesis and wound healing) is specifically tied to foam bodies without
a broad distribution of pore sizes." Appeal Br. 14 (emphasis omitted).
Appellant continues that "the claimed ranges would not deliver the
advantage taught by Mavani and relied upon by the Examiner to support
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Application 14/079,590
[the] conclusion of obviousness." Id. at 14-15. We do not find this
argument persuasive because the Examiner's rejection relies on Mavani only
for the general condition of pore sizes for foam components. The
Examiner's rationale adequately explains why it would have been obvious to
have the pore sizes in Miles be within the broad range of pore sizes specified
in Mavani.
Appellant also argues that "[i]n direct contrast to the Examiner's
rationale, treatment of aneurysms avoid angiogenesis and associated tissue
ingrowth." Appeal Br. 15. However, the Examiner's articulated rationale
relates to why one of ordinary skill in the art would modify Miles with the
teachings of Mavani. Miles is directed to an expanding body for occluding a
left atrial appendage ("LAA") to prevent existing embolic material from
leaving the LAA and to prevent further entry of blood into the LAA to
prevent the further production of embolic material within the LAA. Miles
,-J 49. Miles contemplates the body including a tissue in-growth member for
promoting tissue growth. Id. ,-i,-i 11-13, 48. Consequently, it appears that the
Examiner's articulated rationale is relevant to Miles-which is the reference
being modified by the teachings of Mavani.
To the extent Appellant is suggesting with its arguments (see Appeal
Br. 17) that the combination of Miles and Mavani would not result in "[a]
device for treatment of an aneurysm" with a "component being expandable
from a compressed configuration to an expanded configuration when
released into the aneurysm" as claimed, we are not persuaded of error in the
positions taken by the Examiner in the Final Action and further explained in
the Advisory Action. See Final Act. 4; Adv. Act. (Apr. 26, 2017), 2. More
particularly, we agree with the Examiner's position that the preamble
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reciting "for treatment of an aneurysm" is not given patentable weight where
it merely recites the intended use of a structure. Adv. Act. 2.
In addition, we agree with the Examiner's position that the device of
Miles as modified by Mavani would be capable of expanding from a
compressed configuration to an expanded configuration when released into
an aneurysm from a catheter. Id. We have not been persuaded of a
structural difference between the Miles/Mavani device and the claimed
device. Although features of an apparatus may be recited either structurally
or functionally, claims directed to an apparatus must be distinguished from
the prior art in terms of structure rather than function. In re Schreiber, 128
F.3d 1473, 1477-78 (Fed. Cir. 1997). Therefore, the device of the prior art
meets the recited functionally defined limitation (i.e., "being expandable
from a compressed configuration to an expanded configuration when
released into the aneurysm from a catheter") if it is capable of the recited
function. The prior art reference need not envision the device actually being
used to perform the claimed function. See Schreiber, 128 F.3d at 1477.
Appellant does not provide evidence or persuasive technical reasoning as to
why the component of Miles/Mavani is incapable of the claimed function of
expanding from a compressed configuration to an expanded configuration
when released into an aneurysm from a catheter.
Appellant also presents arguments regarding the Examiner's
determination of optimum or workable ranges of pore sizes for each section
by routine experimentation. Appeal Br. 17-18. More particularly,
Appellant argues that "the Examiner[' s] conclusory statement appears to
suggest that the 'result-effective variable' is pore size and the 'effective
result' is tissue ingrowth and angiogenesis for wound healing." Id. at 17.
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Similar to the argument above, Appellant asserts that "one of ordinary skill
in the art would not have been motivated to find an optimum or workable
pore size (i.e., the 'variable') to promote angiogenesis, tissue ingrowth, and
wou[ n ]d healing (i.e., the 'effective result') because the sought after result
would not be suitable for an aneurysm treatment device." Id. at 18. As
described in more detail above, we note that the Examiner's proposed
rejection relates to the modification of Miles with the teachings of Mavani,
both of which are concerned with tissue ingrowth, thereby supporting that
one of ordinary skill in the art would have been led to optimize the average
porosity of the various sections/regions of the foam component so as to
achieve a desired level of tissue growth.
We have also considered Appellant's argument that "Mavani is
directed to technology located in a completely different part of the body than
Miles and the claimed device, and is used to treat a different problem (i.e.,
fistula closure) than Miles and the claimed device," such that "Mavani fails
to disclose the 'general conditions' of both Miles' LAA occlusion device
and the pending claims (i.e., treating aneurysms)" and "it would not have
been routine skill in the art to determine the claimed porosities recited in
claim l." Id. at 19. Both Miles and Mavani are concerned with tissue
ingrowth to close off an area within the body. See Miles ,-J 48 ("The frame
120 [of the cover member 110] can be configured to support a tissue in-
growth member 122, such as a polymer substrate, or any suitable tissue
promoting or enhancing member. Such tissue in-growth member 122 can be
a porous member, such as reticulated foam, fabric or Dacron®, configured
to hold blood cells and to promote and induce tissue growth."); id. ,-i 49
("[T]he medical device 100 covers or occludes the opening 114 of the LAA
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Application 14/079,590
to seal off the LAA from the left atria."); Mavani ,-J89 ("Expansion of
bodies 15 within the tract 10 provides a porous scaffold to the fistula tract
and may partially or entirely stop the flow of bodily fluids through the tract.
The scaffold provides a matrix that may promote tissue in-growth allowing
the fistula to close."). Thus, we are not persuaded (i) that Mavani fails to
disclose the general conditions of a foam component used to close off an
area of the body, such as Miles' LAA occlusion device nor (ii) that it would
have been beyond routine experimentation to arrive at the specific claimed
porosities. 4
For the foregoing reasons, Appellant does not apprise us of error in
the Examiner's conclusion that the combination of Miles and Mavani
renders obvious the subject matter of independent claims 1 and 23.
Accordingly, we sustain the rejection of claims 1 and 23 under 35 U.S.C.
§ 103(a) as unpatentable over Miles and Mavani. We also sustain the
rejection of claims 3, 4, 7-10, and 25-30 under 35 U.S.C. § 103(a) as
unpatentable over Miles and Mavani, for which Appellant relies on the same
arguments and reasoning as the independent claims. Appeal Br. 19, 24-25.
4 Although not relied on by the Examiner, we note that Miles discloses that
"manipulating the number of [pores] per square inch in the material forming
the body 302, so that the body exhibits a graded porosity" can enable
"various portions of the body [to] compact smaller than other portions of the
body." Miles ,-J 70. Thus, Miles itself provides evidence that the number of
pores per square inch is recognized in the art as a result-effective variable,
with the recognized result being the amount of compacting of the body that
is possible.
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Application 14/079,590
DECISION
The Examiner's decision to reject claims 1, 3, 4, 7-10, 23, and 25-30
under 35 U.S.C. § 103(a) as unpatentable over Miles and Mavani is
affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l .136(a). See 37 C.F.R.
§ l.136(a)(l )(iv).
AFFIRMED
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