Ex Parte Hannes et al

Patent Trials and Appeals Board

Feb 25, 2019

14000576 - (D) (P.T.A.B. Feb. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/000,576 10/28/2013
62836 7590 02/27/2019
Brooks Kushman P.C. / BERLINER & ASSOCIATES
1000 Town Center, 22nd Floor
22nd Floor
Southfield, MI 48075
Ralf Hannes
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.
PHEN0103PUSA 4044
EXAMINER
DUKERT, BRIAN AINSLEY
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
02/27/2019 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):
docketing@brookskushman.com
nwhitlock@brookskushman.com
lwerk@brookskushman.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RALF HANNES and HERMANN MONSTADT
Appeal2018-006040 1
Application 14/000,5762
Technology Center 3700
Before HUBERT C. LORIN, BRUCE T. WIEDER, and
BRADLEY B. BAY AT, Administrative Patent Judges.
BAY AT, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner's
decision to reject claims 1---6 and 8-1 7, which are the only claims pending in
the application. We have jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
1 Our Decision references Appellants' Appeal Brief ("Br.," filed November
15, 2017), the Examiner's Answer ("Ans.," mailed February 7, 2018), and
Non-Final Office Action ("Non-Final Act.," mailed November 16, 2016).
2 Appellants identify "Phenox GMBH" as the real party in interest. Br. 3.
Appeal2018-006040
Application 14/000,576
STATEMENT OF THE CASE
Claimed Invention
The present "invention relates to a membrane implant for the
treatment of vascular malformations, said implant consisting of an
expandable stent and a membrane connected to said stent, wherein the
membrane covers meshes of the stent at least in a central area." Spec. 1, 11.
5-8. Claim 1, the sole independent claim, reproduced below with added
emphasis and formatting, is representative of the subject matter on appeal.
1. Membrane implant for the treatment of vascular
malformations, said implant being implantable by endovascular
methods into the vessel to be treated, wherein the membrane
implant comprising
an expandable stent (4) and
a membrane (2, 3, 5, 11) connected with the stent (4),
with said membrane (2, 3, 5, 11) covering the meshes of the
stent at least in a central region, characterized in that the
membrane (2, 3, 5, 11) is provided in the form of a non woven
fabric comprising plastic fibrils,
wherein the membrane (2, 3, 5, 11) forming a bond with
the stent (4) and, at least partially, being of porous design, and
wherein the membrane comprises an outer layer facing
the wall of the vessel, said outer layer comprising a sponge-like
structure that becomes compressed when the stent is expanded
in the vessel such that a medical substance in the outer layer is
pressed out of the outer layer when the outer layer becomes
compressed.
Br. 9 (Claims Appendix.).
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Application 14/000,576
Rejections
I. Claim 13 is rejected under 35 U.S.C. § 112, fourth paragraph, as being
of improper dependent form for failing to further limit the subject matter of
the claim upon which it depends.
II. Claims 1-6, 8, 9, and 11-16 are rejected under 35 U.S.C. § I02(b) as
anticipated by Shalev et al. (US 2009/0088828 Al, pub. Apr. 2, 2009)
("Shalev"), or alternatively under 35 U.S.C. § I03(a) as being unpatentable
over Shalev.
III. Claims 10 and 17 are rejected under 35 U.S.C. § I03(a) as being
unpatentable over Shalev and Seiler, Jr. et al. (US 4,550,447, iss. Nov. 5,
1985) ("Seiler").
ANALYSIS
Rejection I
The Examiner finds that claim 13 does not further limit claim 1
because "[ c ]laim 13 repeats the same limitations set forth in amended claim
1." (Non-Final Act. 4). According to the Examiner, "[m]erely claiming that
the membrane 'accommodates' a medical substance is not the same as
saying that the device further comprises a medical substance." (Ans. 2).
Appellants disagree and argue that "claim 1 recites how a medical
substance behaves when the stent is expanded in a vessel, while claim 13
recites that the membrane actually contains ('accommodates') a medical
substance." (Br. 4).
We are persuaded by Appellants' arguments. Claim 1 refers to "a
medical substance" only in the context of the functional limitation regarding
the behavior of the outer layer when the stent is expanded. Claim 13 further
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Application 14/000,576
limits claim 1 by placing a structural limitation on the outer layer of the
membrane.
Accordingly, we do not sustain the rejection of claim 13 as failing to
further limit the subject matter of the claim upon which it depends.
Rejection II
Anticipation by Shalev
In rejecting claim 1 as anticipated by Shalev, the Examiner finds that
"Shalev contains all the claimed limitations of the membrane implant ( e.g.
the material, structure, deployment means) but is silent [as] to the membrane
being 'compressed when the stent is expanded in the vessel."' (Non-Final
Act. 6). The Examiner maintains that the functional limitation of claim 1 is
inherent in Shalev. According to the Examiner:
Since the membrane/device as disclosed above [in Shalev] is
substantially identical to the claim, claimed properties or
functions are presumed inherent. In the instant case, the
amendment is considered entirely functional and attempts to
claim the device for how it performs and not what it is.
However, not disregarding the newly amended functional
language, it is the [E]xaminer's position that the device of
Shalev is entirely capable of performing said function. One of
ordinary skill in the art would conclude that, absent any special
features or disclosure, the newly amended limitation was a
function of the membrane [ 's] material, structure, design, and
means of deployment. As Shalev teaches the same material as
recited in claims 1 & 2 (i.e., non-woven plastic fibrils;
polycarbonate urethane), the same fabrication method recited in
claim 4 (i.e., electrospinning), the same porous design as recited
in claim 1, and the same deployment/expansion means recited
in claim 1 (i.e., a stent); it is the [E]xaminer's position that the
newly amended limitation is inherent.
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[] Further, due to the radial force applied by the underlying
stent and the membrane's porous structure, the membrane
would compress to some extent (however small) following
endoluminal expansion against the inner wall of the vessel.
Furthermore, due to Shalev's elastomeric fibers being
electrospun with defined porous evacuations within, the radial
expansion of the underlying stent would also result in some
level/extent of compression. One of ordinary skill would
recognize that a sleeve/membrane fabricated of electrospun
polymeric fibers would compress in a radial thickness
dimension, due to at least the polymeric fibrils further
aligning/stretching, as the stent expanded the membrane to a
larger overall outer/inner diameter and/or circumference.
[] Additionally, one of ordinary skill in the art would
understand that as the membrane material comprises fibrils (22,
24, 26) with a pharmaceutical agent dispersed amongst the
fibrils (30), as the elastic membrane is stretched, some amount
of pharmaceutical will be pressed out as the outer layer is
compressed (i.e., device is expanded).
(Id. at 6-7; see also, Ans. 4--5).
Appellants argue that "Shalev does not teach the release of the
pharmaceutical by compression of a sponge-like structure." (Br. 6).
We are persuaded by Appellants' argument. Even if we agree with
the Examiner's finding that Shalev's disclosure of elastomeric polymer
fibers stretching as the stent is expanded amounts to "a sponge-like structure
that becomes compressed when the stent is expanded in the vessel," we find
that the Examiner has not adequately shown that Shalev inherently discloses
that "a medical substance in the outer layer is pressed out of the outer layer
when the outer layer becomes compressed" as required by claim 1.
To establish anticipation, the claimed subject matter must be met by
the prior art disclosure of a single embodiment, not by a combination of
different embodiments, and must be arranged in the same way as recited in
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Application 14/000,576
the claims. See Net MoneyIN, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008)
("[U]nless a reference discloses within the four comers of the document not
only all of the limitations claimed but also all of the limitations arranged or
combined in the same way as recited in the claim, it cannot be said to prove
prior invention of the thing claimed and, thus, cannot anticipate under 3 5
U.S.C. § 102.").
The Examiner has not adequately shown that a pharmaceutical agent
incorporated in Shalev's structure 12 necessarily will be "pressed out" when
the nonwoven polymer fibers are compressed. The Examiner's finding of
inherency focuses exclusively on the similarity of Shalev's nonwoven
polymer fibers to the claimed nonwoven fabric. (See Non-Final Act. 6
("same material," "same fabrication method," "same porous design," "same
deployment/expansion means.")). But Shalev teaches that the release of
pharmaceutical agent from nonwoven polymer fibers depends on additional
factors that the Examiner has not addressed. Specifically, Shalev discloses
that release of a specific pharmaceutical agent depends on variables in
addition to the type of polymer, including "the method in which the
pharmaceutical agent is introduced into the polymer fibers, the sequence of
layers forming the tubular structure, the matrix morphological peculiarities
of each layer and the concentration of the pharmaceutical agent." Shalev
,r 103.
In relevant part, with regard to the release of pharmaceutical agent
from non-woven polymer fibers, Shalev discloses that "[t]he preferred
mechanism of pharmaceutical agent release from the fibers is by diffusion,
regardless of the technique employed to embed the pharmaceutical agent
therein." Id. ,r 98.
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Shalev discloses various methods for incorporating a pharmaceutical
agent in the fibers. In a preferred embodiment, the stent comprises a number
of sub-layers, and "pharmaceutical agent release during the first hours and
days following implantation may be achieved by incorporating a solid
solution, 3 containing a medicament such as anticoagulants and
antithrombogenic agents, in a sub-layer of readily soluble biodegradable
polymer fibers." Id. ,r 99. "[T]he pharmaceutical agent may be constituted
by particles 28 embedded in the electrospun polymer fibers forming a sub-
layer of tubular structure 12." Id. ,r 100.
Shalev further discloses "an alternative method for incorporating the
pharmaceutical agent in the tubular structure, ensuring pharmaceutical agent
release during the first post-operative days and weeks" wherein "the
pharmaceutical agent is constituted by compact objects 30 distributed
between the electrospun polymer fibers of the tubular structure." Id. ,r 101.
"Compact objects 30 maybe in any known form, such as, but not limited to,
moderately stable biodegradable polymer capsules." Id.
The Examiner's finding that "as the elastic membrane is stretched,
some amount of pharmaceutical will be pressed out as the outer layer is
compressed" (Non-Final Act. 7; Ans. 5) is unsupported by any explicit
disclosure in Shalev. Shalev contains no disclosure that any of the disclosed
methods of incorporating a pharmaceutical agent ( e.g., particles 28 and
compact objects 30) will result in a pharmaceutical agent being "pressed out
3 A solid solution is "[a] homogeneous solid mixture whose constituent
particle concentrations may vary over specified ranges." Academic Press
Dictionary of Science and Technology,
https://search.credoreference.com/content/entry/apdst/solid_solution/
(accessed February 18, 2019).
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Application 14/000,576
of the outer layer when the outer layer becomes compressed" as required by
claim 1. And the Examiner does not provide adequate evidence or technical
reasoning that makes "clear that the missing descriptive matter is necessarily
present in the thing described in the reference, and that it would be so
recognized by persons of ordinary skill." Continental Can Co. USA, v.
Monsanto Co., 948 F.2d 1264, 1268 (Fed. Cir. 1991). Although it is
possible, for example, that Shalev's particles 28 or compact objects 30 may
be "pressed out" of structure 12 when the stent is expanded, that is not
sufficient to show inherency. "Inherency ... may not be established by
probabilities or possibilities. The mere fact that a certain thing may result
from a given set of circumstances is not sufficient." Id. at 1269 ( quoting In
re Oelrich, 666 F.2d 578,581 (CCPA 1981)).
Because the Examiner has not shown that every limitation of claim 1
is disclosed or inherent in a single embodiment of Shalev, we do not sustain
the Examiner's rejection of independent claim 1 under 35 U.S.C. § 102(b) as
being anticipated by Shalev, including dependent claims 2---6, 8, 9, and 11-
16.
Obviousness over Shalev
The Examiner indicates that claims 1---6, 8, 9, and 11-16 are rejected
"in the alternative" as obvious over Shalev. (Non-Final Act. 4).
We are persuaded by Appellants' argument (Br. 7) because the
Examiner has not explained or shown how the contested limitations are
disclosed by Shalev or why they would have been obvious to one of ordinary
skill in the art. In particular, the Examiner acknowledges that Shalev does
not explicitly disclose the contested limitation discussed above (Non-Final
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Act. 6), yet the Examiner has not explained how the Examiner proposes to
modify any particular embodiment of Shalev in order to meet that limitation.
"[R ]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness." In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (citing In re
Lee, 277 F.3d 1338, 1343--46 (Fed. Cir. 2002); In re Rouffet, 149 F.3d 1350,
1355-59 (Fed. Cir. 1998)). "To facilitate review, this analysis should be
made explicit." KSR Int'! v. Teleflex Inc., 550 U.S. 398,418 (2007) (citing
Kahn, 441 F .3d at 988).
Accordingly, we do not sustain the rejection of independent claim 1
under 35 U.S.C. § 103(a). For the same reasons, we also do not sustain the
rejection of dependent claims 2---6, 8, 9, and 11-16. Cf In re Fritch, 972
F.2d 1260, 1266 (Fed. Cir. 1992) ("[D]ependent claims are nonobvious if the
independent claims from which they depend are nonobvious") ( citations
omitted).
Re} ection III
Dependent claims 10 and 17
Rejection III relies on the same deficient finding in Shalev discussed
above, and the Examiner's reliance on the disclosure of Seiler does not
remedy that deficiency. See Non-Final Act. 9-10. For the same reasons
discussed above with respect to independent claim 1, we do not sustain the
rejection of dependent claims 10 and 17.
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DECISION
The Examiner's rejection under 35 U.S.C. § 112 is reversed.
The Examiner's rejection under 35 U.S.C. § 102(b) is reversed.
The Examiner's rejections under 35 U.S.C. § 103(a) are reversed.
REVERSED
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