Ex Parte Richter et al

Patent Trial and Appeal Board

May 22, 2017

10484081 (P.T.A.B. May. 22, 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.
10/484,081 07/08/2004 Yoram Richter 92077.013US1 2778
75004 7590 05/24/2017
CADWALADER, WICKERSHAM & TAFT LLP
ONE WORLD FINANCIAL CENTER
NEW YORK, NY 10281
EXAMINER
WEISBERG, AMY REGINA
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
05/24/2017 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):
DOROTHY. AUTH @ CWT.COM
DOCKETING@CWT.COM
JENNIFER.CHICK@CWT.COM
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte YORAM RICHTER and ELAZER EDELMAN
Appeal 2015-006434
Application 10/484,081
Technology Center 3700
Before LINDA E. HORNER, SUSAN L. C. MITCHELL, and
PAUL J. KORNICZKY, Administrative Patent Judges.
HORNER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Yoram Richter and Elazer Edelman (Appellants)1 seek our review
under 35 U.S.C. § 134 of the Examiner’s decision, as set forth in the Final
Office Action dated May 5, 2014 [hereinafter “Final Act.”], rejecting claims
1, 2, 4, 6, 11, 12, 15, 17-20, 22-24, 26, 27, 30, 33, 35, 38, 41, 42, 46^19,
51-56, 58, and 61-65. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE and enter a NEW GROUND OF REJECTION
pursuant to our authority under 37 C.F.R. § 41.50(b).
1 Appellants identify Medinol Ltd. as the real party in interest. Appeal
Brief 1 (dated December 14, 2014) [hereinafter “Appeal Br.”].
Appeal 2015-006434
Application 10/484,081
CLAIMED SUBJECT MATTER
Appellants’ claimed subject matter relates to “implantable stents for
maintaining the patency of a lumen.” Spec., para. 1. Claims 1,15, 22, 33,
and 55 are independent. Claim 1 is illustrative of the subject matter on
appeal and is reproduced below.
1. A method of generating favorable flow in a diseased
vessel lumen having a diseased shape different from a pre­
diseased shape, comprising:
inserting a stent into said lumen, said stent having a first
end, a second end, and a tapered portion therebetween, said first
end having an expanded cross-sectional diameter matching the
cross-sectional diameter of the pre-diseased vessel lumen and
said tapered portion having a narrow section and a flared section,
said flared section having a expanded cross-sectional diameter
larger than the cross-sectional diameter of the pre-diseased vessel
lumen; and
expanding the stent such that said first end matches the
pre-diseased shape of the vessel lumen and said flared section
artificially widens the pre-diseased shape of the vessel lumen to
minimize flow disturbances at an obstructed treatment site.
REJECTIONS
The Final Office Action includes the following rejections:
1. Claims 1, 2, 4, 6, 11, 12, 15, 17-20, 22-24, 26, 27, 33, 35, 38, 41,
42, 46, 47, 52, 55, 56, 58, and 61-65 stand rejected under
35 U.S.C. § 103(a) as unpatentable over Fischell (US 5,639,274,
2
Appeal 2015-006434
Application 10/484,081
issued June 17, 1997) and Killion (US 6,159,238, issued December
12, 2000).
2. Claims 30, 48, 49, 51, 53, and 54 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Fischell, Killion, and Cox
(US 2001/0010013 Al, published July 26, 2001).
ANALYSIS
First Ground of Rejection
Method claims 1, 2, 4, 6, 11, 12, 15, 17-20, 55, 56, 58, 61, 62, and 64
Independent method claim 1 recites inserting a stent into a diseased
vessel lumen where the stent includes a “flared section having an expanded
cross-sectional diameter larger than the cross-sectional diameter of the pre­
diseased vessel lumen” and expanding the stent such that “said flared section
artificially widens the pre-diseased shape of the vessel lumen to minimize
flow disturbances at an obstructed treatment site.” Corrected Claims
Appendix 1, dated February 11, 2015 [hereinafter “Claims App.”].
Independent claims 15 and 55 recite similar limitations. Id. at 2, 7-8.
The Examiner finds that Fischell teaches a method substantially as
called for in each of claims 1,15, and 55 except that it “fails to teach a stent
with [a] tapered portion therebetween, and said tapered portion having a
narrow section and a flared section, said flared section having an expanded
cross-sectional diameter larger than the cross-sectional diameter of the pre­
diseased vessel lumen.” Final Act. 2-3. The Examiner finds that “Killion
teaches an improved tapered stent” and “expanding the stent to apply
3
Appeal 2015-006434
Application 10/484,081
variable radially expansive force to the vessel wall along the length of the
stent.” Id. at 3 (citing Killion, Fig. 2a). The Examiner explains:
The radially expansive force inherently widens the vessel lumen
in proportion to the magnitude of the force applied (column 5
lines 53-62). Since the force is greatest at the proximal end and
decreases distally along the length of the tapered stent (column 2
line 58-column 3 line 15, column 3 lines 38-59) the stent
artificially widens the pre-diseased shape of the vessel lumen and
will widen the stenosis (column 5 lines 53-62).
Final Act. 3.
Appellants contend that “the appealed claims are directed at the
expansion of the pre-diseased shape of the lumen, rather than the expansion
of the vessel walls.” Appeal Br. 9-10. Appellants assert that the claims
recite “an artificial widening in the pre-diseased shape (widening to a shape
larger than the natural shape of the vessel), not simply an expansion limited
to restore the natural shape of the vessel.” Id. at 11. Appellants argue that
Fischell cannot achieve the claimed artificial widening because after
expansion of Fischell’s stent 15, the vessel lumen is not larger than that of
the pre-diseased shape. Id. (citing Fischell, Fig. 7G).
The Examiner responds that “the pre-diseased shape of the vessel
lumen is the open space within the vessel walls without an obstruction, and
the diseased shape of the vessel lumen is the open space within the vessel
walls with an obstruction.” Ans. 3. The Examiner notes that “the claim
recites ‘artificially widens the pre-diseased shape of the vessel lumen’” and
“does not refer to the post-disease shape of the lumen.” Id. The Examiner
interprets the claim such that “the pre-diseased shape corresponds to the
4
Appeal 2015-006434
Application 10/484,081
vessel without disease thus corresponding to the vessel wall.” Id. at 3-4
(citing Spec., para. 29). The Examiner then explains that Fischell discloses a
method of treatment in Figures 7A-7G that result in “widening the pre­
diseased shape” to restore laminar flow, and that Fischell, as modified by the
tapered stent design of Killion, renders obvious the claimed subject matter.
Id. at 4-5 (depicting widening in an annotated Figure 7G of Fischell).
We disagree with the Examiner’s reading of the claim language. For
instance, claim 1 recites “a method of generating favorable flow in a
diseased vessel lumen.” Claims App. 1 (emphasis added). The claim
language defines the “diseased vessel lumen having a diseased shape
different from a pre-diseased shape.” Id. The claimed method includes the
steps of “inserting a stent into said [diseased vessel] lumen” and “expanding
the stent such that said first end matches the pre-diseased shape of the
[diseased] vessel lumen and said flared section artificially widens the pre­
diseased shape of the [diseased] vessel lumen to minimize flow disturbances
at an obstructed treatment site.” Id. Claims 15 and 55 contain similar
limitations such that the method is performed on a diseased or obstructed
vessel lumen. The claimed method results in the stent changing the shape of
the diseased vessel lumen so that the diseased vessel lumen has a pre­
diseased shape at a first end of the stent and a shape wider than the pre­
diseased shape at a flared section of the stent.
Based on this understanding of the scope of claims 1,15, and 55, we
agree with Appellants that Fischell discloses a method of deploying a stent
that results in returning the vessel lumen to its pre-diseased shape along the
5
Appeal 2015-006434
Application 10/484,081
entire length of the stent, and, thus, Fischell does not show in Figures 7A-
7G “expanding the stent such that. . . said flared section artificially widens
the pre-diseased shape of the vessel lumen to minimize flow disturbances at
an obstructed treatment site.” Claims App. 1.
Appellants further contend that “nothing in Killion teaches or suggests
artificially widening the pre-diseased shape of the vessel lumen, as claimed.”
Id. at 12 (“a stent having variable radial forces along its length does not
automatically result in any artificial widening”). We agree with Appellants
that Killion’s stent does not inherently result in the claimed artificial
widening. Id. Killion discloses a tapered stent in which the radial force
varies along the length of the stent to provide more force in the area of the
stenosis and less force against non-stenosed vessel tissue. Killion, col. 2,
11. 28-32, 48-51. Killion describes that “the stents provide greater force
only where required at a stenosis, without providing too much force in the
region of healthy tissue” and “provide an expanded geometry more closely
tailored to the requirements of a tapering vessel region.” Id. at col. 3,11. 50-
55. As such, Killion appears to avoid a stent with a flared end that
“protrud[es] into, and possibly irritat[es] non-stenosed tissue.” Id. at col. 2,
11. 8-14.
For the foregoing reasons, we agree with Appellants that “the claims
require that the open space of the expanded vessel be larger than the open
space of the vessel in the pre-diseased condition when there is no
obstruction.” Reply Br. 2. We further agree with Appellants that “the stents
described in Fischell and Killion are designed to restore ‘the original
6
Appeal 2015-006434
Application 10/484,081
geometry’ of the vessel before the diseased is developed” and “are not
intended to expand the shape of [the] lumen beyond the original shape of
[the] pre-diseased lumen.” Reply Br. 4. For these reasons, we do not
sustain the rejection of independent method claims 1,15, and 55 and their
dependent claims 2, 4, 6, 11, 12, 17-20, 56, 58, 61, 62, and 64, under
35 U.S.C. § 103(a) as unpatentable over Fischell and Killion.
Device claims 22-24, 26, 27, 33, 35, 38, 41, 42, 46, 47, 52, 54, 63,
and 65
Independent claim 22 is directed to a stent and recites the stent
comprises a “flared section having a predetermined cross-sectional diameter
larger than the cross-sectional diameter of the pre-diseased vessel lumen,
wherein upon expansion said flared section is predetermined to artificially
widen the pre-diseased shape the vessel lumen.” Claims App. 2.
Independent claim 33 is likewise directed to a stent and recites the above-
referenced claim language substantially similar to claim 22. Id. at 3.
The Examiner relies upon the same problematic claim interpretation
and the same findings as to the disclosures in Fischell and Killion in
rejecting these apparatus claims as was discussed supra in the rejection of
the method claims. Final Act. 2—4. For the same reasons provided in our
analysis of the method claims, we likewise do not sustain the rejection of
independent claims 22 and 33 and their dependent claims 23, 24, 26, 27, 35,
38, 41, 42, 46, 47, 52, 63, and 65, under 35 U.S.C. § 103(a) as unpatentable
over Fischell and Killion.
7
Appeal 2015-006434
Application 10/484,081
Second Ground of Rejection
The second ground of rejection of dependent claims 30, 48, 49, 51,
53, and 54 as unpatentable over Fischell, Killion, and Cox is based on the
same interpretation of the claim language of the independent claims
discussed supra. Final Act. 6-7. The Examiner does not rely on Cox to
cure the deficiencies in Fischell and Killion. Id. at 7 (finding that Cox
discloses using the shape of the balloon to control the final shape of the
stent). Accordingly, we also do not sustain the rejection of claims 30, 48,
49, 51, 53, and 54 under 35 U.S.C. § 103(a) as unpatentable over Fischell,
Killion, and Cox.
NEW GROUND OF REJECTION
We enter a new ground of rejection as to all of the claims on appeal
under 35 U.S.C. § 112, first paragraph, for failure to comply with the written
description requirement. In the Appeal Brief, Appellants provide a depiction
of Figure 2c of the application overlaid on a vessel lumen. Appeal Br. 9.
Appellants assert that this depiction “illustrates the vessel lumen after
expansion of the tapered stent that creates an artificial widening of the vessel
lumen.” Id. The Examiner responds that this depiction “is not supported by
the original [Specification and is considered new matter.” Ans. 3 (“The
originally filed [Fjigures omit any drawings showing the device in a blood
vessel.”) Appellants reply that “[t]he [Specification supports the claimed
stent, showing that the first end has been configured to match the shape of
the vessel lumen (Paragraph [0058]), and the tapered portion is larger than
8
Appeal 2015-006434
Application 10/484,081
the first end (See Figs. 2a-7b).” Reply Br. 6; see also Appeal Br. 9-10
(citing Spec, paras. 28, 29, 57, 58, and 73).
To satisfy the written description requirement, “the [original]
specification must describe an invention understandable to that skilled
artisan and show that the inventor actually invented the invention claimed.”
Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010)
(en banc). “[T]he test for sufficiency is whether the disclosure of the
application relied upon reasonably conveys to those skilled in the art that the
inventor had possession of the claimed subject matter as of the filing date.”
Id. “[T]he level of detail required to satisfy the written description
requirement varies depending on the nature and scope of the claims and on
the complexity and predictability of the relevant technology.” Id. The
claimed invention need not be recited in haec verba in the original
specification in order to satisfy the written description requirement. Id. at
1352. “[DJrawings alone may be sufficient to provide the ‘written
description of the invention’ required by § 112, first paragraph.” Vas-Cath,
Inc. v. Mahurkar, 935 F.2d 1555, 1564 (Fed. Cir. 1991).
We reviewed the Specification, including the Figures and the portions
of the Specification cited by Appellants as support for the claimed artificial
widening, and found inadequate support for this claimed subject matter. In
particular, Appellants cite paragraphs 28 and 29 of the Specification as
providing support for the claimed artificial widening. Paragraph 28 of the
Specification describes that “in a straight lumen, the stent may be configured
to introduce an artificial tapering” and, in a straight lumen, “tailoring may be
9
Appeal 2015-006434
Application 10/484,081
accomplished by inducing an artificially tapered section or sections.” The
Specification does not describe, however, that the artificial tapering is
effected by creating a lumen having a cross-sectional diameter that is larger
than the cross-sectional diameter of the pre-diseased vessel lumen. The
artificial tapering could be achieved by placing the first, smaller end of the
stent in the area of the vessel where a lesion is located, such that the
expanded cross-sectional area of the first end is smaller than the pre-diseased
lumen shape, and placing the second, larger end of the stent in an area of the
vessel with no lesion, such that the expanded cross-sectional area of the
second end matches the cross-sectional area of the pre-diseased lumen
shape. For example, adding a flared section to the right of the stent 15 in
Figure 7G of Fischell could result in a stent that would provide an artificial
tapering without resulting in widening of the pre-diseased shape of the
vessel lumen. Paragraph 29 of the Specification similarly describes
“reshaping a lumen to promote more favorable flow regime, e.g., laminar
flow, and minimize or eliminate any areas of flow separation” and that the
“stents are configured so that they have a taper which alters the flow
characteristics of the lumen.” For the same reasons discussed previously,
this description does not demonstrate clearly that Appellants had possession
of reshaping or tapering of the lumen by artificial widening of the pre­
diseased shape of the vessel lumen.
Appellants also cite paragraphs 57 and 58 of the Specification as
providing support for the claimed artificial widening. Paragraph 57
describes stent profile 10 as depicted in Figures 2a-2c. The description
10
Appeal 2015-006434
Application 10/484,081
states, “[t]he embodiment of stent profile 10 shown in Figs. 2a-2c may be
used in a lumen having a non-tapered original shape, and in this case would
change the shape of that lumen to an artificial, tapered shape.” Spec,
para. 57. The Figures do not show, however, a stent having stent profile 10
disposed within a vessel, or otherwise depict the artificial, tapered shape of
the vessel lumen. For the reasons discussed previously, an artificial, tapered
shape does not necessarily have to be achieved by artificial widening of the
pre-diseased shape of the vessel lumen. When a tapered stent is placed
within a lumen having a non-tapered original shape, the stent always will
result in an artificial shape because the original shape was not tapered.
Paragraph 58 of the Specification describes use of stent 10 in a lumen with a
natural taper in which the stent creates a lumen having cross-sectional areas
at either end of the stent that match the original geometry of the pre-diseased
shape of the vessel lumen. In particular, the description states that the first
stent segment 12 may have a cross-sectional area A1 corresponding to the
original shape of a proximal part of the lumen, the second stent segment 14
may have a cross-sectional area A2 corresponding to the original shape of a
distal part of the lumen, and the third stent segment 16 has a tapered
configuration designed to minimize or eliminate flow separation in that
segment. Spec., para. 58. We understand from this description that it is the
configuration of the taper between the first and second stent segments that
minimizes or eliminates flow separation, and artificial widening of the pre­
diseased shape of the vessel lumen is not required to achieve this result.
11
Appeal 2015-006434
Application 10/484,081
Finally, Appellants point to paragraph 73 of the Specification as
supporting the claimed artificial widening. Paragraph 73 describes that
“providing the lumen . . . with an artificial, tapered shape according to
embodiments of the present invention would manipulate the flow regime in
such a way as to at least partially offset non-flow-disturbance related factors,
an end result being a reduction in the risk of restenosis.” For the reasons
discussed previously, the artificial, tapered shape described in this paragraph
does not necessarily require artificial widening of the pre-diseased shape of
the vessel lumen.
For these reasons, we find that the disclosure of the application relied
upon fails to reasonably convey to those skilled in the art that Appellants had
possession of the claimed subject matter as of the filing date. Accordingly,
we enter a new ground of rejection of claims 1, 2, 4, 6, 11, 12, 15, 17-20,
22-24, 26, 27, 30, 33, 35, 38, 41, 42, 46^19, 51-56, 58, and 61-65 under
35 U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement.
DECISION
The rejection of claims 1, 2, 4, 6, 11, 12, 15, 17-20, 22-24, 26, 27, 33,
35, 38, 41, 42, 46, 47, 52, 55, 56, 58, and 61-65 under 35 U.S.C. § 103(a) as
unpatentable over Fischell and Killion is reversed.
The rejection of claims 30, 48, 49, 51, 53, and 54 under 35 U.S.C.
§ 103(a) as unpatentable over Fischell, Killion, and Cox is reversed.
We enter a NEW GROUND OF REJECTION, pursuant to our
authority under 37 C.F.R. § 41.50(b), of claims 1, 2, 4, 6, 11, 12, 15, 17-20,
12
Appeal 2015-006434
Application 10/484,081
22-24, 26, 27, 30, 33, 35, 38, 41, 42, 46-49, 51-56, 58, and 61-65 under
35 U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement.
Section 41.50(b) provides “[a] new ground of rejection pursuant to
this paragraph shall not be considered final for judicial review.” Section
41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the
claims, appellant may again appeal to the Board pursuant to this
subpart.
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be found in
the Manual of Patent Examining Procedure § 1214.01 (9th Ed., Rev.
13
Appeal 2015-006434
Application 10/484,081
07.2015, Nov. 2015).
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l)(iv).
REVERSED; 37 C.F.R, § 41.50(b)
14