COVIDIEN LP

Patent Trials and Appeals Board

Jun 2, 2020

2019004523 (P.T.A.B. Jun. 2, 2020)

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.
14/085,127 11/20/2013 Xiaodong Ma H-
KN-02800US/1213-046US01
6251
137834 7590 06/02/2020
MDT_RTGNV/Shumaker & Sieffert P.A.
Attn: IP Legal Department
826 Coal Creek Circle
Louisville, CO 80027
EXAMINER
NELSON, MICHAEL B
ART UNIT PAPER NUMBER
1787
NOTIFICATION DATE DELIVERY MODE
06/02/2020 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):
pairdocketing@ssiplaw.com
rs.patents.two@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte XIAODONG MA, JUNWEI LI, MIN-SHYAN SHEU,
ANASTASIA RIGHTER, and ARIANA GILMORE
Appeal 2019-004523
Application 14/085,127
Technology Center 1700
BEFORE CATHERINE Q. TIMM, LILAN REN, and
SHELDON M. MCGEE, Administrative Patent Judges.
REN, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1 and 4–14. See Final Act. 3. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real party in interest as “Medtronic plc of
Dublin, Ireland, which is the ultimate parent entity of Covidien LP, a
Delaware limited partnership, having a place of business in Mansfield, MA.”
Appeal Br. 3.
Appeal 2019-004523
Application 14/085,127

2
CLAIMED SUBJECT MATTER
The claims are directed to coated medical devices and “methods for
coating medical implants, in embodiments implants made of inert materials
such as metals, by immobilizing combinations of silanes on surfaces of the
implants.” Spec. ¶ 1. Claim 1, reproduced below, is illustrative of the
claimed subject matter:
1. A medical device, comprising:
a substrate, wherein the substrate comprises a material
selected from the group consisting of glass, ceramics, and metals,
wherein the metal is selected from the group consisting of silver,
copper, steel, aluminum, cobalt, chromium, titanium, niobium,
tantalum, an alloy of silver, an alloy of copper, an alloy of steel,
an alloy of aluminum, an alloy of cobalt, an alloy of chromium,
an alloy of titanium, an alloy of niobium, an alloy of tantalum,
and combinations thereof;
a silane layer comprising at least one sulfur-functional
silane and at least one additional silane, on at least a portion of
the substrate;
at least one additional component bound to the silane
layer, the at least one additional component selected from the
group consisting of monomers, polymers, bioactive agents, and
combinations thereof.
Claims Appendix (Appeal Br. 19).
Appeal 2019-004523
Application 14/085,127

3
REFERENCES
The prior art references relied upon by the Examiner are:
Name Reference Date
Ferrera et al. US 6,241,691 B1 June 5, 2001
Kyomoto et al. US 2011/0027757 A1 Feb. 3, 2011
Nakatsuka JP 2002038105 A Feb. 6, 2002
Yumoto H. Yumoto et al.
Anti-inflammatory
and protective effects
of 2-
methacryloyloxyethyl
phosphorylcholine
polymer on oral
epithelial cells
Society for
Biomaterials 555–563
(2014)
2014

REJECTION
Claims 1 and 4–14 are rejected under 35 U.S.C. § 103 as being
unpatentable over Kyomoto in view of Ferrera and Nakatsuka, with evidence
from Yumoto. Final Act. 3.

OPINION
We review the appealed rejections for error based upon the issues
identified by Appellant and in light of the arguments and evidence produced
thereon. Cf. Ex parte Frye, 2010 WL 889747, *4 (BPAI 2010) (precedential)
(cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011)
(“[I]t has long been the Board’s practice to require an applicant to identify
the alleged error in the examiner’s rejections.”). After having considered the
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Application 14/085,127

4
evidence presented in this Appeal and each of Appellant’s contentions, we
are not persuaded that reversible error has been identified, and we affirm the
Examiner’s § 103 rejection for the reasons expressed in the Final Office
Action and the Answer. We add the following primarily for emphasis.
Claim 12
Appellant argues that the Examiner reversibly erred in rejecting claim
1 for failure to provide a rationale to combine the references. Appeal Br. 7.
Appellant argues that although Ferrera discloses a nickel-titanium stent with
“a strand of radiopaque material, such as platinum or gold” (Ferrera
Abstract) and Kyomoto discloses a stent having a titanium substrate
(Kyomoto ¶ 69), a skilled artisan would not have “considered the Kyomoto
stents to be insufficiently radiopaque” and would not “have looked to
Ferrera or considered modifying Kyomoto in view of Ferrera.” Appeal Br. 7.
Appellant argues that Kyomoto discloses various materials and the skilled
artisan “would begin the inquiry with an assessment of whether the listed
materials in Kyomoto would provide such functionality rather than move to
a secondary reference.” Id.
We are not persuaded by this argument. “[A]ny need or problem
known in the field of endeavor at the time of invention and addressed by the
patent can provide a reason for combining the elements in the manner
claimed.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 419–20 (2007). As
the Examiner points out, Ferrera teaches gold or platinum as two preferred

2 Appellant does not separately argue the obviousness rejections of claims 4–
7 and 10–13. The rejections of these claims stand or fall with the
obviousness rejection of claim 1. See Appeal Br. 15; see also 37 C.F.R.
§ 41.37(c)(1)(vii).
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materials “to provide a radiopaque marker during interventional therapeutic
treatment or vascular surgery.” Ferrera Abstract (cited in Final Act. 4); see
Ans. 7. Ferrara discloses these radiopaque materials “dramatically enhance[]
the radiopacity of the” cable that forms Ferrara’s stent. Ferrara 8:56–57.
This argument is not persuasive also because it lacks evidentiary
support. “Attorneys’ argument is no substitute for evidence.” Johnston v.
IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989). As the Examiner points
out, Appellant’s argument that metals used in Kyomoto are sufficiently
radiopaque is unsupported by evidence. Ans. 7. Appellant does not address
the lack of evidentiary support. See Reply Br. 2–16. The argument is,
therefore, unpersuasive of error in the Examiner’s finding that it would have
been “advantageous to include a radiopaque metal like gold in the stent
substrate in order to allow the stent to be tracked via the [radiopaque] marker
properties of the gold.” Final Act. 4.
Appellant next argues that because Kyomoto states that “[i]t is
essential to use . . . metal capable of forming a hydroxyl group on a surface
of the metal by surface treatment” (Kyomoto ¶ 69), the Examiner fails to
explain why the skilled artisan “would have considered ‘gold with the
titanium,’ as a viable substrate material that contacts the binder layer.”
Appeal Br. 8–9.
This argument is not persuasive. The Examiner explains that Ferrera
describes the advantages of including gold in a stent and accordingly finds
that “the substrate that results from the combination of Kyomoto and Ferrera
would still include exposed titanium portions and therefore would still
include the hydroxyl groups for bonding with the silane layer.” Ans. 9. “[I]f
a technique has been used to improve one device, and a person of ordinary
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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.” KSR, 550 U.S. at 417. In this case, the Examiner
explains that the gold and titanium in the proposed combination each
improves the stent as taught by the prior art. See id. Appellant’s additional
argument that a skilled artisan would not have had a reason to consider
further modification based on Kyomoto and Ferrera (Reply Br. 8) – even if
supported by evidence – does not identify error in the Examiner’s conclusion
that it is within the ordinary skill to apply the prior art teachings.
Appellant next argues that a skilled artisan would not have combined
Nakatsuka with Kyomoto because “Nakatsuka is directed to solving a
different problem than the problem addressed in Kyomoto.” Appeal Br. 14.
According to Appellant, “Nakatsuka describes formulation used as dental
adhesives” which “is not described in the context of improving the adhesion
of silane binders in general.” Id. at 13–14 (emphases omitted).
To the extent that Appellant’s argument is that Nakatsuka is non-
analogous art, the correct focus of the analogous art test is not whether the
prior art references are analogous to each other, but whether the references
are analogous art to the claimed subject matter. In re Kahn, 441 F.3d 977,
986–7 (Fed. Cir. 2006). Therefore, Appellant’s argument is unpersuasive
because it does not apply the correct legal standard. Moreover, Appellant’s
argument does not identify error in the Examiner’s finding that the silane in
Kyomoto and Nakatsuka are similar in chemical structure. Compare Ans. 7–
8, with Reply Br. 13.
Appellant’s argument about the predictability of success is also
unpersuasive. See Appeal Br. 14 (arguing, for example, that “Nakatsuka fails
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to disclose or suggest that such adhesives would improve adhesion of the
phosphorylcholine biocompatible layer of Kyomoto or provide an
explanation as to why one of ordinary skill in the art would have considered
the Nakatsuka dental adhesives relevant for such purposes”). First and
foremost, all of the features of one reference need not be bodily incorporated
into the other reference and the skilled artisan is not compelled to blindly
follow the teaching of one prior art reference over the other without the
exercise of independent judgment. See Lear Siegler, Inc. v. Aeroquip Corp.,
733 F.2d 881, 889 (Fed. Cir. 1984). Moreover, the Examiner finds that all
the recited structural components are known in the art and each such
component serves its known purpose in arriving at the recited apparatus. See
KSR, 550 U.S. 398, 416 (2007). “Obviousness does not require absolute
predictability of success. . . . For obviousness under § 103, all that is
required is a reasonable expectation of success.” In re O’Farrell, 853 F.2d
894, 903–04 (Fed. Cir. 1988).
The rejection of claim 1––and, the rejection of claims 4–7 and 10–13
that depend from claim 1––is sustained for no reversible error has been
identified.
Claims 8 & 9
Appellant argues claims 8 and 9 as a group. These claims recite
various compositions of the “at least one additional component bound to the
silane layer.” See Appeal Br. 15. The dispositive limitation is “wherein the at
least one additional component bound to the silane layer is selected from . . .
phosphorylcholiness” as recited in claim 8. See id. at 20.
Appellant argues that the Examiner reversibly erred in failing to
explain that the combined structure would have “sufficient compatibility
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with the outer biocompatible coating of phosphorylcholine described in
Kyomoto.” Appeal Br. 15. We are not persuaded by this argument. As noted
supra, “[o]bviousness does not require absolute predictability of success. . . .
For obviousness under § 103, all that is required is a reasonable expectation
of success.” In re O’Farrell, 853 F.2d at 903–04. The claim language at
issue does not require a particular level of biocompatibility and Appellant
does not structurally distinguish the prior art. The rejection is therefore
sustained.
Claim 14
Claim 14 depends from claim 1 and additionally recites “wherein the
medical device comprises a stent.”
Appellant argues that the Examiner reversibly erred because the prior
art stents have “different constructions, components, and functionality.”
Appeal Br. 16. Appellant argues that the prior art references show
“conflicting stent structures” and the Examiner fails to explain how a
modification would have been made. Id.
As noted supra, all of the features of one reference need not be bodily
incorporated into the other reference. Lear Siegler, 733 F.2d at 889. The
claim language of claim 14 requires no more than “a stent” which is
undisputedly taught in the prior art. The rejection of claim 14 is sustained.

CONCLUSION
The Examiner’s rejection is affirmed.
More specifically,
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Application 14/085,127

9
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 4–14 103 Kyomoto, Ferrera,
Nakatsuka, Yumoto
1, 4–14
Overall
Outcome:
1, 4–14

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED