Ex Parte Slazas et al

Patent Trial and Appeal Board

Aug 8, 2017

13076474 (P.T.A.B. Aug. 8, 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.
13/076,474 03/31/2011 Robert Slazas COD5267USNP 3812
27777 7590 08/10/2017
JOSEPH F. SHIRTZ
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
EXAMINER
YABUT, DIANE D
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
08/10/2017 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):
j nju spatent @ corn s .j nj. com
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROBERT SLAZAS, JUAN LORENZO, and PETER FORSYTHE1
Appeal 2016-003831
Application 13/076,474
Technology Center 3700
Before RICHARD J. SMITH, RYAN H. FLAX, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to an occlusive device suitable for endovascular treatment of
an aneurysm in a region of a parent vessel in a patient, and related methods.
Claims 1—6, 9—19, 21—26, and 31—38 are on appeal as rejected under 35
U.S.C. § 101 for double patenting, and § 103(a).2 We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Parties in Interest as “DePuy Synthes
Products, Inc., . . . which is an affiliate of Johnson & Johnson.” Br. 1.
2 Claims 7—8, 20, and 27—30 have been withdrawn. Final Action 2; Br. 2.
Appeal 2016-003831
Application 13/076,474
STATEMENT OF THE CASE
The Specification explains, “[t]he invention relates to implants [for
use] within body vessels and more particularly to occlusive devices
including stents which are irreversibly modified based on localized pressure
differentials.” Spec. 11. The Specification further explains:
This invention results from the realization that the neck of an
aneurysm in a parent vessel can be occluded without also
occluding nearby vessels, such as perforator vessels,
communicating with the parent vessel by providing a device
which irreversibly erodes or ruptures, including deforming,
substantially only based on differential pressure and penetrating
fluid flow into the perforator vessels. The device effectively
senses the presence of an ostium of a perforator vessel and
modifies itself to permit flow into the ostium, thereby
minimizing ischemia, while continuing to substantially block
flow into the aneurysm.
Spec. ]fl5.
Claims 1, 16, 31, and 36—38 are independent claims. Claim 1 is
representative and is reproduced below:
1. An occlusive device suitable for endovascular
treatment of an aneurysm in a region of a parent vessel in a
patient, comprising:
a structure having a fixed porosity and having dimensions
suitable for insertion into vasculature of the patient to reach the
region of the aneurysm in the parent vessel; and
a frangible material supported by the structure which
initially provides a substantial barrier to flow through the
frangible material and is capable of at least one of localized
rupturing and localized eroding, in the presence of a pressure
differential arising at an ostium of a perforator vessel
communicating with the parent vessel, within an acute time
period to minimize ischemia downstream of the perforator
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Application 13/076,474
vessel, the frangible material includes a non-biodegradable
portion and a biodegradable portion.
Br. 8 (Claims App’x) (underlining omitted).
The following rejections are on appeal:
Claims 1—6, 9—19, 21—26, and 31—38 stand provisionally rejected
under 35U.S.C. § 101 as claiming the same invention as claims 1—34 of co­
pending U.S. Patent Application No. 13/798,818. Final Act. 3.
Claims 1—4, 9, 16—18, 21, 31, 32, and 36—38 stand rejected under 35
U.S.C. § 103(a) over Bose,3 Jones,4 and Helmus.5 Id. at 4—5.
Claims 5, 19, and 32 stand rejected under 35 U.S.C. § 103(a) over
Bose, Jones, Helmus, and Alcime.6 Id. at 10.
Claims 6, 26, 34, and 35 stand rejected under 35 U.S.C. § 103(a) over
Bose, Jones, Helmus, and MacGregor.7 Id. at 10.
Claims 10-13, 22, 23, and 33 stand rejected under 35 U.S.C. § 103(a)
over Bose, Jones, Helmus, and Boismier.8 Id. at 11.
Claims 14, 15, 24, and 25 stand rejected under 35 U.S.C. § 103(a)
over Bose, Jones, Helmus, and Smith.9 Id. at 12.
3 U.S. Pat. App. Pub. No. US 2007/0239261 A1 (pub. Oct. 11, 2007)
(“Bose”).
4 U.S. Pat. App. Pub. No. US 2006/0095111 A1 (pub. May 4, 2006)
(“Jones”).
5 U.S. Pat. App. Pub. No. US 2003/0153972 A1 (pub. Aug. 14, 2003)
(“Helmus”).
6 U.S. Pat. No. 5,632,772 (issued May 27, 1997) (“Alcime”).
7 U.S. Pat. No. 4,101,984 (issued July 25, 1978) (“MacGregor”).
8 U.S. Pat. App. Pub. No. US 2008/0071348 A1 (pub. Mar. 20, 2008)
(“Boismier”).
9 U.S. Pat. No. 7,189,256 (issued Mar. 13, 2007) (“Smith”).
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Application 13/076,474
DISCUSSION
Only those arguments made by Appellants in the Brief have been
considered in this Decision. Arguments not presented in the Brief are
waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015).
Double Patenting
Appellants do not present arguments regarding the provisional double
patenting rejection. Accordingly, we summarily affirm the rejection. See
Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008) (the Board need not
consider the merits of an uncontested ground of rejection).
Obviousness and Claims 1—4, 9, 16—18, 21, 31, 32, and 36—38
We find the Examiner has established a prima facie case that claim 1
would have been obvious over Bose, Jones, and Helmus. See Final Action
4—9; Ans. 2—3. The combined references teach and suggest each element of
claim 1 and it would have been reasonable for the skilled artisan to combine
the teachings of the cited prior art references because they are each directed
to the same field of endeavor, i.e., cardiovascular implants. In fact, each of
Bose and Jones is directed to stents for treating aneurysms such that the
aneurysm is blocked by the device while adjacent branching blood vessels
are not. Bose, abstract; Jones, abstract. As determined by the Examiner, it
would have been reasonable for skilled artisans to consult each of these
references in developing a device to occlude aneurysms, but otherwise allow
blood flow, like that of Appellants’ claims. Ans. 2—3. Appellants have not
produced evidence showing, or persuasively argued, that the Examiner erred
in these determinations.
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In briefing non-obviousness Appellants address only claim 1, which
we find to be representative. Br. 4—7. Therefore, each of these rejected
claims falls with claim 1. 37 C.F.R. § 41.37(c)(l)(iv); In re Kaslow, 707
F.2d 1366, 1376 (Fed. Cir. 1983) (“Since the claims are not separately
argued, they all stand or fall together”).
Appellants contend:
Bose’s device 10 acts as what is known in the art as a flow
diverter. Bose’s device requires no further covering or material
to solve the problem of treating a parent vessel having an
aneurysm while maintaining blood flow in branch vessels.
Despite this fact, the Examiner suggests adding a frangible
material to Bose’s device 10. The problem is already solved.
Br. 5. Appellants contend that the cited prior art would not be combined for
this reason. This is not a persuasive argument.
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Inti Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “[W]hen a patent
‘simply arranges old elements with each performing the same function it had
been known to perform’ and yields no more than one would expect from
such an arrangement, the combination is obvious.” Id. at 417.
Contrary to Appellants’ contention, neither Bose nor Jones can
reasonably be said to represent the final attempt by those in the field to
address the issue of treating an aneurysm with a stent, but not occluding
adjacent blood flow.10 It cannot reasonably be disputed that those working
10 Dozens of patents and/or patent applications concerning stenting to
occlude aneurysms, but otherwise allow blood flow, cite Bose as relevant
prior art. See Google Patents (Bose’s “Cited By” section), at
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in the field of aneurysm treatment would consider the noted problem
“already solved” and cease seeking improvements in the technology. In an
obviousness analysis, “[w]e start from the self-evident proposition that
mankind, in particular, inventors, strive to improve that which already
exists.” Pro—Mold & Tool Co., Inc. v. Great Lakes Plastics, Inc., 75 F.3d
1568, 1573 (Fed. Cir. 1996).
Under the above cited precedent, we affirm the obviousness rejection
of claim 1. Claims 2-4, 9, 16—18, 21, 31, 32, and 36—38 fall with claim 1.
Obviousness and Claims 5, 19, and 32
The Examiner found that “Alcime teaches an expandable supportive
branched endoluminal grafts, wherein suitable polymer materials have pore
size being in order of about 10 microns to above 80 micron[s],” and
“[therefore it would have been obvious for one of ordinary skill in the art to
have the pore size of frangible material to be at least 10 micro [n]s for
purposes of selectively allowing and/or obstructing blood flow through the
vessel.” Final Action 10. Similar to the first obviousness rejection, we find
the Examiner has established a prima facie case that claims 5, 19, and 32
would have been obvious over Bose, Jones, Helmus, and Alcime.
Appellants have not produced evidence showing, or persuasively argued,
that the Examiner erred in these determinations.
Appellants contend “[t]he rejection of claims 5, 19 and 32 stands or
falls with the rejection of claims 1—4, 9, 16—18, 21, 31, 32, 36—38.” Br. 6.
https://patents.google.eom/patent/US20070239261Al/en#citedBy, visited
Aug. 8, 2017.
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Therefore, for the same reasons discussed above with respect to claim 1, we
affirm this rejection.
Obviousness and Claims 6, 26, 34, and 35
The Examiner found that “MacGregor teaches cardiovascular
prosthetic device and implants with por[o]us systems, wherein the porous
material coating has a thickness of about 20 to 300 microns,” and
Therefore it would be obvious for one of ordinary skill in
the art at the time of the invention to have the material thickness
of Jones ranging between 10 to 500 microns as taught by
MacGregor for purposes of having proper fixed[] placement of
implant in the vessel and preventing any unnecessary movement
of the implant.
Final Action 10—11. Similar to the first obviousness rejection, we find the
Examiner has established a prima facie case that claims 6, 26, 34, and 35
would have been obvious over Bose, Jones, Helmus, and MacGregor.
Appellants have not produced evidence showing, or persuasively argued,
that the Examiner erred in these determinations.
Appellants contend “[t]he rejection of claims 6, 26 and 34—35 stands
or falls with the rejection of claims 1—4, 9, 16—18, 21, 31, 32, 36—38.” Br. 6.
Therefore, for the same reasons discussed above with respect to claim 1, we
affirm this rejection.
Obviousness and Claims 1CC13, 22, 23, and 33
The Examiner found that “Boismier teaches a medical device wherein
the stent can include a tubular member formed out of porous magnesium
foam (see Para [0064]),” and “[therefore it would have been obvious for
one of ordinary skill in the art to have the structure be made out of porous
foam for purposes of enhancing the strength and or structural support of the
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Application 13/076,474
stent,” as recited by claims 10 and 22. Final Action 11. The Examiner also
found that the prior art combination “teach[es] the occlusive device of
claim[s] [11 and 23] wherein the frangible material (14) includes at least one
biodegradable composition (as taught in Helmus) interspersed through at
least a portion of the porosity of the foam (as taught in Boismier),” and
“teaches the occlusive device of claim [12] wherein the foam includes
porous urethane (see Para [0065]),” and “teaches the occlusive device of
claim [13] wherein the biodegradable material includes polycaprolactone
(Para [0065]),” and “teaches the occlusive device of claim [33] wherein the
structure includes a substantially non-biodegradable (Para [0016] and [0028]
of Boismier) porous foam (see Para [0064] of Boismier) defining the fixed
porosity through which the biodegradable material is dispersed (Para
[0016]).” Id. Similar to the first obviousness rejection, we find the
Examiner has established a prima facie case that claims 10-13, 22, 23, and
33 would have been obvious over Bose, Jones, Helmus, and Boismier.
Appellants have not produced evidence showing, or persuasively argued,
that the Examiner erred in these determinations.
Appellants contend “[t]he rejection of claims 10-13, 22—23 and 33
stands or falls with the rejection of claims 1—4, 9, 16—18, 21, 31, 32, 36—38.”
Br. 6. Therefore, for the same reasons discussed above with respect to claim
1, we affirm this rejection.
Obviousness and Claims 14, 15, 24, and 25
The Examiner found
Smith teaches an endoluminal device and system and
method for detecting a change in pressure differential across an
endoluminal device (see abstract). Smith teaches the graft or
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Application 13/076,474
frangible material responding to pressure differential that results
from blood flow in the vessel. Pressure differential equivalent to
one to fifty mm Hg can be calculated as taught in Smith (see col
5, lines 1-20; claim 1).
Therefore it would have been obvious for one of ordinary
skill in the art at the time of the invention to have frangible
material being capable of responding to pressure differential for
purposes of detecting change in pressure which would evidence
of a leak in the vasculature, such that it can accordingly be cured
or prevented from further damaging the vasculature.
Final Action 12. The Examiner also found the prior art combination
“teaches the occlusive device of claim 1, wherein the acute time period is
less than ten minutes (the time required for blood to flow in parent vessel
can be modified as desired by an ordinary skill in the art through
experimentation and testing[)],”finding this time period of claims 15 and 25
to be an optimizable variable. Id. Similar to the first obviousness rejection,
we find the Examiner has established a prima facie case that claims 14, 15,
24, and 25 would have been obvious over Bose, Jones, Helmus, and Smith.
Appellants have not produced evidence showing, or persuasively argued,
that the Examiner erred in these determinations.
Appellants contend “[t]he rejection of claims 14—15 and 24—25 stands
or falls with the rejection of claims 1—4, 9, 16—18, 21, 31, 32, 36—38.” Br. 6.
Therefore, for the same reasons discussed above with respect to claim 1, we
affirm this rejection.
SUMMARY
The double patenting rejection is affirmed.
The obviousness rejections are each affirmed.
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TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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