Ex Parte Jones-McMeans

Patent Trial and Appeal Board

Jan 30, 2017

13429268 (P.T.A.B. Jan. 30, 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.
13/429,268 03/23/2012 Jennifer Jones-McMeans 031318-02300 9099
90259 7590 02/01/2017
Hughes Hubbard and Reed LLP
One Battery Park Plaza
New York, NY 10004
EXAMINER
BARIA, DINAH N
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
02/01/2017 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):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JENNIFER JONES-MCMEANS1
Appeal 2015-003600
Application 13/429,268
Technology Center 3700
Before MURRIEL E. CRAWFORD, ROBERT A. POLLOCK, and
TARA L. HUTCHINGS, Administrative Patent Judges.
POLLOCK, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the final rejection of
claims 1—5 and 7—12. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
STATEMENT OF THE CASE
Appellants’ invention relates to intraluminal drug-eluting stents “for
improving coronary luminal diameter of small vessels in patients having
small vessels, such as diabetics, with symptomatic heart disease.” Spec.,
Abstract, 12.
1 Appellants identify the real party-in-interest as Abbott Cardiovascular Sys.
Inc. App. Br. 4.
Appeal 2015-003600
Application 13/429,268
Claim 1, the sole independent claim at issue, recites:
1. A stent comprising:
a body having a deployed diameter of 2.25 mm, the body
including a plurality of struts having a thickness of less
than approximately 95 pm;
a coating including at least one polymer adhered to the body
wherein the coating has a thickness of less than
approximately 12 pm; and
a therapeutic agent included in the polymer coating at a
concentration of between about 50 pg/cm2 and about 150
pg/cm2,
wherein 8 months to about 12 months following implantation
of the stent in the small vessel results an in-stent and in­
segment late loss of less than about 0.20 mm and 0.16
mm, respectively, and in-segment and in-stent binary
restenosis rates of about 9.6% and 3.8%, respectively.
Claims 1—5 and 7—12 stand rejected under 35 U.S.C. § 103(a) as
obvious over the combination of Stone2 and XIENCE.3
ANALYSIS
We have reviewed Appellant’s contentions that the Examiner erred in
rejecting claims 1—5 and 7—12 as unpatentable over the cited art. App. Br.
10—17. With respect to claims 1—3, 5 and 7—12, we disagree with Appellant
contentions and, to the extent not otherwise clarified below, adopt the
findings regarding the scope and content of the prior art set forth in the
2 Stone et al., Comparison of an Everolimus-Eluting Stent and a Paclitaxel-
Eluting Stent in Patients with Coronary Artery Disease, 299( 16) JAMA
1903-13 (2008).
3 The Xience™ VEverolimus Eluting Coronary Stent System: Instructions
for Use, Abbott Vascular (2008).
2
Appeal 2015-003600
Application 13/429,268
Examiner’s Answer. Our opinion with respect to the rejection of claim 4 is
set forth below. We highlight and address the following:
Findings of Fact
FF1. According to the Specification, “Drug eluting stents (“DES”)
generally result in lower restenosis and revascularization rates as
compared to bare metal stents in vessels having a diameter greater than
approximately 3.0 mm (“large vessels”).” Id. 14. However, even with
the use of drug-eluting stents, “vessels having a diameter of. . . less than
3.0 mm (“small vessels”) continue to be clinically and angiographically
at a disadvantage to larger vessels due to the inability of the small
diameter to accommodate neointimal hyperplasia.” Id. For example,
whereas “[vjarious DES for treating small vessels having typical
diameters of 2.25 mm” are known, “these small-vessel DES have not led
to significantly reduced late loss diameter or percent diameter stenosis
like their large-vessel DES counterparts,” possibly because “the narrow
lumen of the smaller diameter vessels are more prone to
revascularization.” Id. (citing, eg., Moses et al., “Safety and Efficacy of
the 2.25-mm Sirolimus-Eluting Bx Velocity Stent in the Treatment of
Patients with De Novo Native Coronary Artery Lesions: the SIRIUS 2.25
trialf 98(11) Am. J. Cardiol. 1455-60 (2006)); id. 1 6.
FF2. The Specification further states that “[cjommercially available small-
vessel DES have greater strut thicknesses and polymer thicknesses
compared to the DES of the present invention. Id. 144. “The lower strut
thickness and polymer thickness of the present invention compared to the
other 2.25 mm DES are understood by the inventors to be associated with
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Application 13/429,268
the more favorable angiographic and clinical results (e.g., lower
revascularization rates).” Id.', see 145 & Table I.
FF3. Stone discloses XIENCE V stents comprising a plurality of cobalt-
chromium alloy struts having a thickness of 0.0813 mm (81.3 pm) and
coated with 7.8 pm coating of a biocompatible fluoropolymer containing
everolimus, a semisynthetic macrolide immunosuppressant. Stone, 1904.
FF4. Stone discloses the results of the SPIRIT III randomized clinical trial
comparing the safety and efficacy of everolimus-eluting XIENCE V
stents (deployed diameter of 2.5, 3.0, and 3.5 mm) to paclitaxel-eluting
stents in patients with coronary artery disease. See id., Abstract.
Measured at 8—12 months post-implantation, the XIENCE V stents were
at least numerically superior to the comparator in terms of in-stent late
loss (0.16 mm vs. 0.30 mm), in-segment late loss (0.14 mm vs. 0.26
mm), in-stent restenosis rate (2.3% vs. 5.7%), and in segment restenosis
rate (4.7% vs. 8.9%). Id. 1907, Table 2.
FF5. Stone further notes that
a significant interaction was present between diabetes and stent
type of the major adverse cardiac endpoint.. . . this difference
was driven by the 62% lower rate of major adverse cardiac
events in patients with diabetes who were treated with
paclitaxel stents compared with patients without diabetes who
were also treated with paclitaxel stents, an unlikely finding that
may have been due to chance alone. The differences between
the two devices were also less apparent in larger vessels (which,
compared with small vessels, may be able to accommodate
more neointimal hyperplasia before the ischemic threshold is
reached) and in longer lesions (which, compared with shorter
lesions, may have a greater statistical likelihood or restenosis
developing in a single spot, despite less volumetric neointimal
hyperplasia).
4
Appeal 2015-003600
Application 13/429,268
Id. 1911—12 (footnote omitted).
FF6. XIENCE discloses that XIENCE V stents comprise, as the drug
component, “[a] conformal coating of a non-erodible polymer loaded
with 100 gg/cnr of everolimus.” XIENCE, 3. The references teaches
that XIENCE V stents are available in 2.5, 2.75, 3.0, 3.5, and 4.0 mm
diameters, and that “[t]he drug load is 100 pg/cm2 for all product sizes.”
Id. at 4. The reference also confirms that XIENCE V stents were used in
the SPIRIT III clinical trial. Id. 14-15.
Analysis
Claims 1, 7—9
The Examiner contends that the combination of Stone and XIENCE
disclose that XIENCE V stents embody all physical limitations of
independent claim 1 but for the “a deployed diameter of 2.25 mm,” which
the Examiner finds is “a normal design possibility . . . and does not involve a
novel step. Ans. 7—\\ see id. at 4 (“It is a well-known concept that stents can
be made in a variety of different deployed diameters, in order to
appropriately fit the diameter of the vessel being served. It would have been
obvious and well within the capability of one skilled in the art at the time of
the invention to determine an appropriate deployed diameter for a stent,
including 2.25mm, as claimed.”).
With respect to the non-structural limitations of claim 1, “wherein 8
months to about 12 months following implantation of the stent in the small
vessel results an in-stent and in-segment late loss of less than about 0.20 mm
and 0.16 mm, respectively, and in-segment and in-stent binary restenosis
rates of about 9.6% and 3.8%, respectively,” and related language in claims
7—9, the Examiner finds that these claim phrases “do not hold any patentable
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Application 13/429,268
weight since they are directed only to clinical results found in a group of
patients after implantation of the stent.” See id. at 4.
Appellant argues that the Examiner errs in considering a stent of
2.25 mm a design choice. App. Br. 13—16. In particular, Appellant contends
that in disclosing that “‘[t]he reference vessel diameter of all study lesions
was required to be between 2.5 and 3.75mm,’” Stone “expressly teaches
away from a 2.25 mm diameter stent. Id. at 13—14 (quoting Stone, 1904)
(emphasis removed). We do not find Appellant’s argument persuasive.4
That the clinical study reported by Stone only used stents with
deployed diameters of 2.5, 3.0, and 3.5 mm, does not “criticize, discredit, or
otherwise discourage” the use of smaller diameter stents (see In re Fulton,
391 F.3d 1195, 1201 (Fed. Cir. 2004)) nor, as the Examiner notes, does it
mean “that those are the only diameters a stent could be made to achieve”
(Ans. 7). To the contrary, we accept the Examiner’s finding that “[i]t is a
well-known concept to those of ordinary skill in the art that stents can be
made in a variety of different deployed diameters in order to appropriately
fit the diameter of the vessel being served.” Id.
Consistent with the Examiner’s position, Appellant’s Specification
confirms that for treating small vessels, the prior art taught that the use of
4 We also do not find persuasive Appellant’s argument that because Stone
teaches that certain differences between the everolimus- and paclitaxel-
eluting stents were less apparent in larger vessels, “reducing the 2.5mm
diameter of the stents in Stone to 2.25mm, as claimed, would not likely
produce a functionally equivalent stent.” See App. Br. 14; FF 5. Attorney
argument is not evidence. In re Pearson, 494 F.2d 1399, 1405 (CCPA
1974). Appellant’s conclusion is unsupported by logic or evidence of
record. See Ans. 8;
6
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Application 13/429,268
drug eluting stents having a diameter of 2.25 mm was well-known, and
indeed, “typical.” See FF1—2. Accordingly, given that the available range
of XIENCE V stents (2.5, 2.75, 3.0, 3.5, and 4.0 mm) did not include the
2.25 mm diameter known to be useful in the treatment of small vessels (see
FF 6), we agree with the Examiner that it would have been obvious to make
a comparable stent having a deployed diameter of 2.25 mm, as described by
independent claim 1, “in order to appropriately fit the diameter of the vessel
being served.” See Ans. 7. This amounts to no more than “the predictable
use of prior art elements according to their established functions.” KSR Int'l
Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007); see id (“[I]f a technique has
been used to improve one device, and a person of ordinary skill in the art
would recognize that it would improve similar devices in the same way,
using the technique is obvious unless its actual application is beyond his or
her skill.”).
Appellant further argues that the Examiner errs in failing to accord
patentable weight to the non-structural limitations of claims 1, and 7—9.
App. Br. 11—13, 16—17. We do not find Appellant’s arguments persuasive.
As noted above, we agree with the Examiner that it would have been
obvious to modify the XIENCE V stents disclosed in Stone and XIENCE to
have a deployed diameter of 2.25 mm, thus obtaining the stent with all of the
physical characteristics set forth in claim 1. As Appellant has not presented
any evidence of secondary considerations, such as arguing that the results
obtained in using such a stent are unexpected, we agree with the Examiner
that the claimed clinical results are “an inherent property of the device.” See
Ans. 6. Moreover, “‘it is elementary that the mere recitation of a newly
discovered function or property, inherently possessed by things in the prior
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Application 13/429,268
art, does not cause a claim drawn to those things to distinguish over the prior
art.’” In re Best, 562 F.2d 1252, 1254—55 (CCPA 1977) (quoting In re
Swinehart, 439 F.2d 210, 212-13 (CCPA 1971)).
Where, as here, the claimed and prior art products are
identical or substantially identical, or are produced by
identical or substantially identical processes, the PTO can
require an applicant to prove that the prior art products do
not necessarily or inherently possess the characteristics of his
claimed product. . . . Whether the rejection is based on
“inherency” under 35 U.S.C. § 102, on “prima facie
obviousness” under 35 U.S.C. § 103, jointly or alternatively,
the burden of proof is the same, and its fairness is evidenced
by the PTO’s inability to manufacture products or to obtain
and compare prior art products.
Id. at 1255 (citation omitted).
For the reasons set forth above, we affirm the rejection of claims 1
and 7—9.
Claims 2, 3, 5, and 10
Appellant further argues that the rejection of claims 2—3, 5, and 10
should be reversed because these claims recite particular features not
disclosed or suggested by the prior art. App. Br. 16—17. We do not find
Appellant’s arguments persuasive. Claim 2 recites that “the therapeutic
agent is an immunosuppressive agent,” and Claim 3 specifies that the
concentration of the therapeutic agent is “about 100 jig/ml.” As noted by the
Examiner, Stone discloses that the XIENCE V stent comprises an
immunosuppressive agent (i.e., everolimus) (Ans. 3; see FF 3), whereas
XIENCE teaches that the concentration of the everolimus in the polymer
coating of XIENCE V stents is 100 jig/ml (Ans. 4; see FF6). With respect to
claims 5 and 10, respectively, we agree with the Examiner that Stone teaches
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Application 13/429,268
stents comprising “a cobalt chromium alloy” and “a plurality of stmts having
a thickness of approximately 81 pm.” Ans. 3 (citing Stone 1904); see FF3.
For the reasons set forth above, we affirm the rejection of claims 2, 3,
5, and 10.
Claim 4
Appellant further argues that the rejection of claim 4 should be
reversed because the cited art fails to teach or suggest the claimed “coating
thickness [of] between 7.1 pm and 7.6 pm.” See App. Br. 16. In setting
forth the rejection, the Examiner relies on Stone as teaching this element.
Ans. 3. Stone, however, teaches a coating thickness of 7.8 pm. See FF 3;
Stone 1904 (disclosing that everolimus “is released from a thin (7.8 pm),
nonadhesive, durable, biocompatible fluoropolymer coated onto a low-
profile ... flexible cobalt-chromium stent”). Because the Examiner fails to
explain why a coating thickness of 7.8 pm renders obvious the range set
forth in claim 4, we do not sustain the rejection.
Claims 8, 11, and 12
As Appellant has not presented any additional substantive arguments
directed to claims 8, 11, and 12, we are not convinced of Examiner error
regarding these claims. See In reLovin, 652 F.3d 1349, 1356 (Fed. Cir.
2011) (“We conclude that the Board has reasonably interpreted Rule 41.37
to require applicants to articulate more substantive arguments if they wish
for individual claims to be treated separately.”). Accordingly, we sustain the
Examiner’s rejection of claims 8, 11, and 12 (not argued separately). See 37
C.F.R. § 41.37(c)(l)(iv).
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Application 13/429,268
SUMMARY
I. We affirm the rejection of claims 1—3, 5, and 7—12 under § 35
U.S.C. 103(a) as obvious over the combination of Stone and XIENCE.
II. We reverse the rejection of claim 4 under § 35 U.S.C. 103(a) as
obvious over the combination of Stone and XIENCE.
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-IN-PART
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