Ex Parte Marchand et al

Patent Trial and Appeal Board

Oct 26, 2017

13439754 (P.T.A.B. Oct. 26, 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.
13/439,754 04/04/2012 Philippe Marchand 1265.002 4529
24955 7590 10/30/2017
ROGITZ & ASSOCIATES
Jeanne Gahagan
4420 Hotel Circle Court
SUITE 230
SAN DIEGO, CA 92108
EXAMINER
WEISBERG, AMY REGINA
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
10/30/2017 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):
Noelle@rogitz.com
eofficeaction @ appcoll.com
John@rogitz.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PHILIPPE MARCHAND, BRIAN J. COX, ROBERT F.
ROSENBLUTH, JOHN NOLTING, TAN Q. DINH,
and THOMAS C. WILDER III
Appeal 2017-000745
Application 13/439,7541
Technology Center 3700
Before ULRIKE W. JENKS, TIMOTHY G. MAJORS, and
KRISTI L. R. SAWERT Administrative Patent Judges.
SAWERT, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) from the rejection of
claims 1—8, 12—14, 18, 19, 23—25, 29, and 30 ofU.S. Patent Application No.
13/439,754 (“the ’754 application”). We have jurisdiction under 35 U.S.C.
§ 6(b). We affirm-in-part.
1 Appellants identify Sequent Medical Inc. as the real party in interest.
Appeal Br. 2.
Appeal 2017-000745
Application 13/439,754
STATEMENT OF THE CASE
Claims 1—8, 12—14, 18, 19, and 23—25, 29, and 30 are on appeal and
can be found at pages 15—23 of the Appeal Brief. Claims 1—8, 14, and 30
stand rejected under 35 U.S.C. § 103(a) for obviousness over Amplatz.2
Final Act. 2—8. Claims 12, 13, 18, 19, 23—25, and 29 are rejected under 35
U.S.C. § 103(a) for obviousness over Amplatz in view of Rosqueta.3 Id. at
8—19. Independent claim 1 is representative. Claim 1 provides:
1. A device for implantation within a vascular defect or
aneurysm, comprising:
a self-expanding resilient outer layer including:
a proximal end,
a distal end,
a longitudinal axis,
a plurality of elongate filaments disposed in a woven
structure,
the outer layer being movable to a radially constrained
elongated state configured for delivery within a microcatheter
with the elongate filaments extending longitudinally from the
proximal end to the distal end radially adjacent each other along
a length of the filaments, and
the outer layer being biased to an expanded relaxed state
with a longitudinally shortened configuration relative to the
radially constrained state with the elongate filaments being
bundled and secured relative to each other at the distal end of
the outer layer and the elongate filaments being bundled and
secured relative to each other at the proximal end of the outer
layer, the woven filaments forming a smooth path radially
expanded from the longitudinal axis between the proximal end
and distal end including a plurality of openings in the outer
layer formed between the woven elongate filaments, the outer
2 Kurt Amplatz et al., U.S. Patent Publication No. US 2009/0062841
A1 (Mar. 5, 2009) (“Amplatz”).
3 Arturo S. Rosqueta & Marla G. Aboytes, U.S. Patent No. 8,142,456
B2 (Mar. 27, 2012) (“Rosqueta”).
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Application 13/439,754
layer having a distal-most surface end defining a distal contour;
and
an inner layer forming an enclosed volume which is
disposed within a cavity of the outer layer, the inner layer
including a plurality of woven filamentary members which are
secured relative to each other at a free distal end of the inner
layer and which are secured relative to each other and the
proximal end of the outer layer at a proximal end of the inner
layer with the free distal end of the inner layer being unsecured
to the outer layer such that the inner layer forms a separate lobe
from the outer layer and the free distal end of the inner layer
can longitudinally shorten independently of the outer layer, the
inner layer having a distal-most surface defining a distal
contour, the distal contour of the inner layer being the same as
the distal contour of the outer layer at least in the expanded
relaxed state, an internal gap being established between the
distal-most surface of the outer layer and the distal-most surface
of the inner layer in the expanded relaxed state, the internal gap
being between 5% and 40% of a total longitudinal height of the
device measured along a longitudinal axis of the device.
Appeal Br. 15—16.
LEGAL STANDARD
A claimed invention is unpatentable if the differences between it and
the prior art are “such that the subject matter as a whole would have been
obvious at the time the invention was made to a person having ordinary skill
in the art.” 35 U.S.C. § 103(a) (pre-AIA). To assess whether the subject
matter would have been obvious, the Board follows guidance in Graham v.
John Deere Co., 383 U.S. 1 (1966) and KSRInt’l Co. v. Teleflex, Inc., 550
U.S. 398 (2007). “Where a skilled artisan merely pursues ‘known options’
from ‘a finite number of identified, predictable solutions,’ the resulting
invention is obvious under Section 103.” In re Cyclobenzaprine
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Application 13/439,754
Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063,
1070 (Fed. Cir. 2012) (quoting KSR, 550 U.S. at 421).
DISCUSSION
On appeal, the Board “reviews the obviousness rejection for error
based upon the issues identified by appellant, and in light of the arguments
and evidence produced thereon.” Ex parte Frye, 94 USPQ2d 1072, 1075—76
(BPAI 2010) (Precedential). We review the Examiner’s rejections, based on
the challenges presented by Appellants, below.
Claims 1—8, 12, 13, and 30
The Examiner rejected claims 1—8 and 30 under 35 U.S.C. § 103(a)
for obviousness over Amplatz, and claims 12 and 13 for obviousness over
Amplatz in view of Rosqueta. Final Act. 2—6 & 8—10. Because both of the
rejections rely on the teachings of Amplatz, we consider the rejections
together because the same issue is dispositive for both rejections. We have
reviewed Appellants’ arguments in the Briefs, the Examiner’s Final Office
Action, and the Examiner’s Answer to the Appellants’ arguments. Upon
review of the record, we find that the Examiner did not establish by a
preponderance of the evidence that the invention recited in claims 1—8, 12,
13, and 30 would have been obvious over the cited prior-art references.
The invention recited in claims 1—8, 12, 13, and 30 is directed to a
device for implantation within a vascular defect or aneurysm that includes a
self-expanding outer layer and an inner layer disposed within a cavity of the
outer layer. Appeal Br. 2—3 (claim 1). Of importance here, in the expanded
relaxed state of the device, an internal gap exists between the distal-most
surface of the inner layer and the distal-most surface of the outer layer. Id.
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As claimed, the internal gap constitutes 5% to 40% of the total longitudinal
height of the device. Id.
Figure 55 of the Specification illustrates the internal gap 365 between
the inner layer 380 and the outer layer 384 of the device 376:
Spec. (Fig. 55); see also id. at 64:23—66:2 (“[A]n internal gap between a top
or distal end [378] of the inner structure [380] and the inner surface at the
distal end of the outer structure [384], as indicated by arrow 365 in FIG. 55,
may be between about 0.2 mm and about 2.5 mm.”). The Specification
states that
[w]ith an internal termination of the inner structure 380, the
potential problem of length matching and buckling between the
outer shell 3 84 and the inner structure 380 may be minimized due
to the ability of the inner layer or structure 380 to collapse
without affecting, or minimally affecting, the collapse or radial
compression of the outer layer or shell 384.
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Id. at 64:37-31.
Amplatz discloses a multi-layer medical device for treating a target
site within the body, such as a vascular defect or aneurysm. Amplatz || 3,
45. As the Examiner explained, and Appellants do not contest, Amplatz
teaches every limitation of claim 1, except for the internal gap having the
claimed dimensions of between 5% and 40% of the total longitudinal height
of the device. See Final Act. 3^4 (citing Amplatz || 17, 50, 54, 57, 70, 86,
90). The Examiner pointed to Figure 12b of Amplatz for illustrating the
internal gap. We have added the double arrow to show the space that the
Examiner referred to as the internal gap:
Amplatz, Fig. 12b (annotation added).
Specifically, the Examiner stated that Figure 12b shows “an internal
gap . . . established between the distal-most surface of the outer layer [220]
and the distal-most surface of the inner layer [220].” Final Act. 4. The
Examiner acknowledged that Amplatz does not explicitly state that the
internal gap constitutes between 5% and 40% of the total longitudinal height
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of the device. Id. But the Examiner reasoned that an internal gap between
5% and 40% would have been obvious to an ordinarily skilled artisan,
because “it has been held that where the general conditions of a claim are
disclosed in the prior art, discovering the optimum or workable ranges
involves only routine skill in the art.” Id. at 4 (citing In reAller, 220, F.2d
454, 456 (CCPA 1955)). The Examiner elaborated that “the free distal end
of the inner structure is free floating thus capable of shortening
independently of the permeable shell, thus providing an internal gap being
between 5% and 40% of a total longitudinal height of the device measured
along a longitudinal axis of the device.” Id.
In response to Appellants’ Appeal Brief arguments, the Examiner
maintained the rejection in the Answer. Ans. 2—5. The Examiner again
acknowledged that “Amplatz fails to teach explicit dimensions,” but
explained that “Amplatz clearly teaches there is a gap between the inner and
outer layers.” Id. at 4—5. The Examiner continued:
The claim recites the gap is between 5-40% which is an
extremely large range of values. Amplatz clearly teaches the two
layers are not connected at one end thus resulting in a gap and
the two layers may move relative to one another. As indicated in
the final rejection, such a gap size would have been obvious to
one of ordinary skill in the art at the time of the invention when
merely examining the disclosed figures of Amplatz, see figure
12B. The claimed gap size is obvious in view of the figures.
Id. at 5.
We reverse this rejection because the Examiner’s obviousness
rejection is not supported by a preponderance of the evidence. In the Final
Office Action, the Examiner relied on Aller to state that “discovering the
optimum or workable ranges” of the internal gap would have been obvious.
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Final Act. 4. We agree with Appellants, however, that the Examiner’s
reliance on Aller is improper because the Examiner failed to show that the
dimensions of the internal gap are a result-effective variable. Appeal
Br. 10-11. Specifically, “where the general conditions of a claim are
disclosed in the prior art, it is not inventive to discover the optimum or
workable ranges by routine experimentation.” In re Applied Materials, Inc.,
692 F.3d 1289, 1295 (Fed. Cir. 2012) (citing In re Aller, 220 F.2d454, 456
(CCPA 1955)). But, “[t]his rule is limited to cases in which the optimized
variable is a ‘result-effective variable.”’ Id. (citing In re Antonie, 559 F.2d
618, 620 (CCPA 1977)).
Even assuming arguendo that Figure 12b of Amplatz teaches an
internal gap between the outer and inner layers of the medical device, the
Examiner did not provide any evidence that explains, with specificity, why
an ordinarily skilled artisan would have considered that internal gap to be a
result-effective variable. The Examiner also did not explain why an
ordinarily skilled artisan would have had a reason to optimize the
dimensions of the internal gap. This omission is decisive here, because the
Examiner does not point to any teaching in Amplatz (or in the art generally)
describing a reason for designing these types of medical devices to include
an internal gap. In contrast, Appellants’ Specification explains that an inner
gap is useful for obviating the need for length matching, and to prevent
buckling between the outer shell and the inner structure. Spec, at 64:37—31.
In the Answer, the Examiner did not rely on a “result-effective
variable” rationale. Instead, the Examiner appeared to rely exclusively on
Figure 12b, stating that the length of the internal gap would have been
obvious to an ordinarily skilled artisan by “merely examining” the figure.
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Ans. 5. But as Appellants correctly point out, ‘“it is well established that
patent drawings do not define the precise proportions of the elements and
may not be relied on to show particular sizes if the specification is
completely silent on the issue.’” Reply Br. 2—3 (quoting Hockerson
Halberstadt, Inc. v. AVIA Group Intern., Inc., 222 F.3d 951, 957 (Fed. Cir.
2000)); see also In re Olson, 212 F.2d 590, 592 (CCPA 1954) (“Ordinarily
drawings which accompany an application for a patent are merely
illustrative of the principles embodied in the alleged invention claimed
therein and do not define the precise proportions of elements relied upon to
endow the claims with patentability.”).
Here, the Examiner does not point us to any written description in
Amplatz referencing an internal gap. Put differently, there is no persuasive
evidence that an internal gap does, in fact, exist between the distal-most
surface of the outer layer and the distal-most surface of the inner layer of
Amplatz’s medical device. And although Amplatz states that the inner layer
at the distal end of the device illustrated in Figure 12b “has a clamp 220 that
free floats and is separate from the clamp for the outer layer,” Amplatz | 86,
we find that a clamp that free floats, alone, does not sufficiently describe or
suggest an internal gap having the claimed dimensions exists between the
inner layer and the outer layer in the device’s relaxed expanded state.
For these reasons, we reverse the rejection of claims 1—8 and 30 under
35 U.S.C. § 103(a) for obviousness over Amplatz. Because the rejection of
claims 12 and 13 under 35 U.S.C. § 103(a) for obviousness over Amplatz in
view of Rosqueta also relies on Amplatz for teaching “the internal gap being
between 5% and 40% of a total longitudinal height of the device measured
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along a longitudinal axis of the device,” see Final Act. 8—11, we reverse this
rejection as well.
Claims 14, 18, 19, 23—25, and 29
The Examiner rejected claim 14 as obvious over Amplatz and claims
18, 19, 23—25, and 29 over as obvious over Amplatz in view of Rosqueta.
Final Off. Act. 6—7 & 10—19. After considering the entirety of the evidence
and Appellants’ arguments, we conclude that the weight of the evidence
favors the Examiner’s conclusion of obviousness.
Claims 14, 19, and 25 are independent claims similar to claim 1, but
instead of reciting dimensions of an internal gap, recite other dimensions of
the claimed device. Claim 14 recites that the
average opening size of the outer layer in the extended relaxed
state is less than about 0.016 inches with the average opening
size defined by the expression (1.7/Nt)(tiD-Nt/2 X dw) where D
is a diameter of the outer layer in the expanded relaxed state in
inches, Nt is the total number of elongate filaments in the outer
layer, and dw is the diameter of smallest filaments of the outer
layer in inches.
Appeal Br. 18—19 (claim 14). Claim 19 recites that the
outer layer in a constrained state has an outer transverse diameter
of less than about 0.04 inches defined by the expression
1.48((Nidi2 ± Nsds2)) /2 where Ni is the number of largest filaments
in the outer layer, Ns is the number of smallest filaments in the
outer shell, di is the diameter of the largest filaments in inches,
and ds, is the diameter of the smallest filaments in inches.
Id. at 20 (claim 19). Finally, claim 25 recites that the
outer layer in the expanded state has a radial stiffness of about
0.03 lbf to about 0.284 lbf defined by the expression (1.2 X 106
lbf/D4)(Nidi4 + Nsds4) where D is the diameter of the outer layer
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in the expanded state in inches, Ni is the number of large
filaments in the outer layer, Ns is the number of small filaments
in the outer layer, di is the diameter of the largest filaments in
inches, and ds, is the diameter of the smallest filaments in inches.
Id. at 22 (claim 25).
As to claim 14, the Examiner reasoned that Amplatz teaches an
average opening size of the outer layer in the expanded relaxed state of less
than about 0.016 inches. Final Act. 7 (citing Amplatz | 55). Amplatz
teaches pore openings (or “fenestrations”)—created by braiding the strands
of the medical device—having an area of about 0.00015 to 0.1 square
inches. Amplatz | 55. The Examiner explained, and we are persuaded, that
taking the square root of that area (to find the linear dimensions of the
opening size) results in a range of linear dimensions that overlaps with the
claimed range of “less than about 0.016 inches.”4 Ans. 5—6.
Appellants do not clearly challenge that finding, but rather argue that
Amplatz fails to associate those pore openings to the expanded relaxed state,
and fails to recite the claimed equation (1 .7/Nt)(J)-Nt/2 X dw). Appeal
Br. 11—12; Reply Br. 3^4. As to the former, we agree with the Examiner
that the dimensions provided by Amplatz are in the expanded relaxed state,
because Amplatz teaches that the fenestrations must be “sufficiently small so
as to slow the blood flow through the wall of the device and to facilitate
thrombus formation thereon.” Amplatz | 55. Put differently, Amplatz
describes the dimensions needed when the medical device is expanded in
4 Specifically, the square root of the range “0.00015 to 0.1” square
inches as disclosed in Amplatz, is 0.0122 to 0.31 inches. Thus, “less than
0.016” overlaps with Amplatz’s disclosed range.
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place and affecting blood flow. Appellants present insufficient evidence or
scientific reasoning to rebut the Examiner’s findings. See In re Geisler, 116
F.3d 1465, 1470 (Fed. Cir. 1997) (attorney argument no substitute for
evidence). Thus, we are not persuaded that the Examiner erred.
As to the latter, the Examiner explained, and we agree on this record,
that Amplatz’s overlapping fenestration sizes would necessarily meet the
claimed equation (1.7/Nt)(J)-Nt/2 X dw). Appellants’ arguments do not
sufficiently rebut the Examiner’s findings. An examiner meets the initial
“burden of production by adequately explaining the shortcomings [he]
perceives so that the applicant is properly notified and able to respond.” In
re Jung, 637 F.3d 1356, 1362 (Fed. Cir. 2011) (quotation omitted). The
burden then shifts to the applicant “to prove that the subject matter shown to
be in the prior art does not possess the characteristic relied on.” In re Best,
562 F.2d 1252, 125A-55 (CCPA 1977).
As noted above, Amplatz teaches a range of opening sizes that
overlaps with Appellants’ claimed range. By showing this, the Examiner set
forth an adequate basis to support a prima facie case that the recited equation
is necessarily satisfied by Amplatz’s disclosed medical devices. Appellants
failed to provide persuasive evidence to the contrary. Thus, the Examiner
was correct in maintaining the rejection of claim 14 (and its dependent claim
18). Best, 562 F.2d at 125A-55.
Similarly with claim 19, the Examiner relied on Rosqueta’s teaching
of a delivery diameter of “less than about 0.050 inches” and explained that
the combination of Amplatz and Rosqueta thus suggests a medical device
meeting the claimed equation of 1.48((Nidi2 ± Nsds2))/2. Final Off. Act. 13—
14 (citing Rosqueta 2:36-42). Appellants admit that Rosqueta teaches a
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diameter of less than about 0.050 inches, but assert that Rosqueta’s range
“envisions a potentially unlimited number of diameters between zero and
0.05,” and thus is “so broad” that “the claim is patentable.” Appeal Br. 12—
13. We disagree. “A prima facie case of obviousness typically exists when
the ranges of a claimed composition overlap the ranges disclosed in the prior
art.” In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). Here,
Rosqueta’s disclosed range of “less than about 0.050 inches” thus overlaps
and encompasses the claimed range of “less than about 0.04 inches.”
Appellants further argue “there [is] no ‘close enough for government work’
test for obviousness.” Appeal Br. 13. But, “[i]n cases involving overlapping
ranges,” our reviewing court has “consistently held that even a slight overlap
in range establishes a prima facie case of obviousness.” Peterson, 315 F.3d
at 1329. Thus, Appellants have not sufficiently rebutted the Examiner’s
prima facie case with evidence or persuasive scientific reasoning.
Appellants also argue that the combination of Amplatz and Rosqueta
does not disclose or suggest the claimed equation of 1.48((Nidi2 + Nsds2))/2.
Appeal Br. 13. But again, the Examiner explained, and we agree on this
record, that the claimed equation is necessarily met by the prior art. Final
Act. 13—14. Appellants only provide attorney argument that is not supported
by evidence. Geisler, 116 F.3d at 1470. Thus, because we have no evidence
to the contrary, we affirm the rejection of claim 19 (and its dependent claims
23 and 24).
Finally, we note that Appellants have not responded to the Examiner’s
rejection of independent claim 25. Thus, we affirm the Examiner’s rejection
of claim 25 (and its dependent claim 29). See 37 C.F.R. § 41.37(c)(l)(iv).
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SUMMARY
We reverse the rejection of claims 1—8, 12, 13, and 30. We affirm the
rejection of claims 14, 18, 19, 23—25, and 29.
AFFIRMED-IN-PART
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