Ex Parte Pacetti et al

Patent Trial and Appeal Board

Jan 23, 2018

13846859 (P.T.A.B. Jan. 23, 2018)

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.
13/846,859 03/18/2013 Stephen Pacetti 050623.01603 2878
01/25/201845159 7590
SQUIRE PB (Abbott)
275 BATTERY STREET, SUITE 2600
SAN FRANCISCO, CA 94111-3356
EXAMINER
NGUYEN, PHU HOANG
ART UNIT PAPER NUMBER
1747
NOTIFICATION DATE DELIVERY MODE
01/25/2018 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):
sfripdocket @ squirepb.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEPHEN PACETTI, SYED HOSSAINY,
YIWEN TANG, and MANISH GADA
Appeal 2017-003949
Application 13/846,859
Technology Center 1700
Before TERRY J. OWENS, CHRISTOPHER C. KENNEDY, and
DEBRA L. DENNETT, Administrative Patent Judges.
DENNETT, Administrative Patent Judge.
DECISION ON APPEAL1
STATEMENT OF THE CASE
Appellant2 appeals under 35 U.S.C. § 134(a) from the Examiner’s
Final Rejection of claims 1—8, which constitute all the claims pending in this
application. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 In our Opinion, we refer to the Specification filed March 18, 2013
(“Spec.”); the Final Action mailed November 5, 2015 (“Final Act.”); the
Appeal Br. filed June 29, 2016 (“Br.”); and the Examiner’s Answer mailed
September 12, 2016 (“Ans.”). Appellant did not file a Reply Brief.
2 Appellant identifies Abbott Cardiovascular Systems Inc. as the real party in
interest. Br. 1.
Appeal 2017-003949
Application 13/846,859
The invention involves intravascular stents used in percutaneous
transluminal angioplasty as scaffoldings and for physically holding open
and, if desired, expanding, a vessel wall. Spec. 1,11. 16—24. Stent crimping
is a critical step in manufacturing stents. Id. 2,11. 4—5. The invention
addresses stents with polymer coatings, which are generally softer, weaker,
and less durable than the underlying stent material, and a crimping process
to minimize damage to the polymer coatings. Id. 4,11. 1—4, 21.
Claim 1, reproduced below, is illustrative of the claimed subject
matter:
1. A method of manufacturing a stent-balloon assembly,
comprising:
(a) providing a stent having a coating comprising a
polymer and a drug, the polymer having (1) a glass transition
temperature above room temperature and (2) a shore hardness
of 60D to 95D or 65D to 90D;
(b) positioning the stent on a balloon of a catheter
assembly;
(c) increasing the temperature of the polymer to a
temperature to change the polymer to a softer state; and
(d) mounting the stent on the balloon while the polymer
is in a softer state, such that after mounting, the polymer
becomes harder, wherein the softer state is defined as
decreasing the shore hardness of the polymer by 10 to 50
percent.
Br. (App’x A, 1).
REFERENCES
The Examiner relies on the follow prior art in rejecting the claims on
appeal:
Hijlkema et al. US 2002/0143382 A1 Oct. 3, 2002
(“Hijlkema”)
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Appeal 2017-003949
Application 13/846,859
Pacetti US 6,574,497 B1 June 3,2003
Ping Xu, Ethylene-vinyl alcohol copolymer, Polymer Data
Handbook, Oxford University Press (1999) (“Polymer Data
Handbook”)
REJECTIONS3
The Examiner maintains and Appellant seeks review of the rejection
under 35 U.S.C. § 103(a) of claims 1—8 over Hijlkema in view of Pacetti and
Polymer Data Handbook. Final Act. 2-4; Br. 3.
OPINION
Appellant argues all pending claims as a group. Br. 4—7. We select
claim 1 as representative of the group.
The Examiner determines that the combination of Hijlkema and
Pacetti, as evidenced by Polymer Data Handbook, explicitly discloses or
renders obvious all elements of claim 1. Final Act. 2—3; Ans. 5. The
Examiner specifically finds that Hijlkema teaches “changing the temperature
(thermal regulation) of a polymer to change the polymer to a softer state”
and “raising the temperature to reach a desired resiliency (corresponding to
the claimed lowering of] the shore hardness).” Final Act. 2.
Appellant acknowledges that Hijlkema states that the surface of the
coating “may be either heated or cooled,” but argues that Hijlkema,
considered as a whole, teaches only making a soft coating harder. Br. 5
(citing Hijlkema 20, 26, and 35).
3 The Examiner’s provisional obviousness-type double patenting rejection of
the claims over claims 76—83 of co-pending Application No. 10/725,698 is
moot, as that application is abandoned.
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Appeal 2017-003949
Application 13/846,859
While some specific embodiments discussed in detail in Hijlkema
concern temporarily increasing the hardness of the coating, the disclosure of
the reference is not so limited. See In re Applied Materials, Inc., 692 F.3d
1289, 1298 (Fed. Cir. 2012) (“A reference must be considered for everything
that it teaches, not simply the described invention or a preferred
embodiment.”). Hijlkema discloses thermal regulation of a coated work-
piece during reconfiguration of the work-piece, temporary modification of
the hardness of the coated work-piece, and adjusting the temperature of the
coating. Hijlkema Title, Abstract, 129. None of “thermal regulation,”
“modification of the hardness,” or “adjusting the temperature” are limited
solely to cooling the temperature of the coating and making it harder.
Hijlkema states, “the temperature of the existing surface of the coating may
be either heated or cooled.” Id. 130. In addition, Hijlkema explicitly
discloses “rais[ing] the temperature of the coating rather than lower[ing] it to
reach the desired resiliency.” Id. 145. For purposes of § 103, a reference is
prior art for all that it discloses. Symbol Techs., Inc. v. Opticon, Inc., 935
F.2d 1569, 1578 (Fed. Cir. 1991). Thus, Hijlkema discloses heating a
polymer, which one of ordinary skill in the art at the time of the invention
would have understood to change the polymer to a softer state.
Appellant also argues that claim 1 requires the shore hardness be
decreased by 10 to 50% when the polymer has a glass transition temperature
above room temperature and the polymer has a shore hardness of 60D to
95D of 65D to 90D. Br. 5.
Appellant acknowledges that Hijlkema discloses SIBS as a polymer
and that the glass transition temperature of SIBS depends at least on the
blocks which make up the polymer. Id. at 6. In fact, SIBS may have glass
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Appeal 2017-003949
Application 13/846,859
transition temperatures below and above room temperature; these values are
inherent to the particular SIBS copolymer. In addition, Hijlkema discloses
using “any other suitable polymer” (Hijlkema 127), which could include
polymers with a glass transition temperature above room temperature.
Polymers disclosed by Hijlkema therefore include those with a glass
transition temperature above room temperature.
Hijlkema does not recite specific ranges of shore hardness of the
polymer, shore hardness being one measure of hardness in polymers,
elastomers, and rubbers. However, Hijlkema discusses modifying the
hardness of a polymer coating on a stent-balloon assembly by thermal
regulation of the assembly (work-piece) to resist damage during crimping.
Hijlkema ]Hf 4—7. Claim 1 claims modifying the shore hardness of a polymer
coating on a stent-balloon assembly by increasing the temperature of the
polymer to decrease the shore hardness by 10 to 50 percent. Br. (Claims
App’x). The Specification indicates that the invention addresses a need for a
crimping process that minimizes damage to the polymer coatings of stents.
Spec. 4. Therefore, Hijlkema and claim 1 both disclose polymers with the
same or similar properties of hardness/shore hardness. Hijlkema suggests
using the same type of polymers for the same purpose as in claim 1 and the
Specification. Hijlkema discloses the general conditions of claim 1. By
routine optimization, starting with similar polymers, one of ordinary skill in
the art at the time of the invention would have arrived at a polymer with the
properties recited in claim 1. In reAller, 220 F.2d 454, 456 (CCPA 1955)
(“[Wjhere 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 Kulling, 897 F.2d 1147, 1149 (Fed. Cir. 1990)
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Application 13/846,859
(upholding a finding that the amount of eluent to be used in a washing
sequence was a matter of routine optimization where the reference failed to
provide any numerical quantities).
Appellant does not show reversible error by the Examiner in rejecting
claim 1, and we sustain the rejection. We also sustain the rejection of claims
2-8. 37 C.F.R. § 41.37(c)(l)(iv).
DECISION
The rejection of claims 1—8 is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv)(2015).
AFFIRMED
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