Ex Parte Ruane

Patent Trial and Appeal Board

Dec 8, 2017

13926515 (P.T.A.B. Dec. 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.
13/926,515 06/25/2013 Patrick H. Ruane 2209-4 7742
31554 7590 12/12/2017
CARTER, DELUCA, FARRELL & SCHMIDT, LLP
445 BROAD HOLLOW ROAD
SUITE 420
MELVILLE, NY 11747
EXAMINER
BOWMAN, ANDREW J
ART UNIT PAPER NUMBER
1717
NOTIFICATION DATE DELIVERY MODE
12/12/2017 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):
docket @ cdfslaw. com
tgiordano@cdfslaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PATRICK H. RUANE
Appeal 2017-004847
Application 13/926,515
Technology Center 1700
Before CHUNG K. PAK, JAMES C. HOUSEL, and
JANE E. INGLESE, Administrative Patent Judges.
INGLESE, Administrative Patent Judge.
DECISION ON APPEAL
Appellant1 requests our review under 35 U.S.C. § 134(a) of a final
rejection of claims 1, 2, and 4—222. We have jurisdiction over this appeal
under 35 U.S.C. § 6(b).
We REVERSE.
1 Appellant is the Applicant, The Spectranetics Corporation, which,
according to the Appeal Brief filed April 5, 2016 (“App. Br.”), is the real
party in interest. App. Br. 1.
2 Appellant cancelled claim 3 in an amendment filed December 7, 2015, and
the Examiner confirmed entry of the amendment in an Advisory Action
issued January 8, 2016.
Appeal 2017-004847
Application 13/926,515
STATEMENT OF THE CASE
Appellant claims a method of forming a coated medical device. App.
Br. 2—3. Claim 1 illustrates the subject matter on appeal and is reproduced
below:
1. A method of forming a coated medical device
comprising:
applying a coating to an outer surface of a medical
device, the coating including a therapeutic agent dispersed in a
matrix of a polymer or oligomer excipient;
post-processing the medical device by immersion in a
solvent or solution, thereby selectively removing a substantial
portion of the polymer or oligomer excipient from the matrix
in which the therapeutic agent is dispersed; and
sterilizing the post-processed medical device,
wherein the coating comprises less than 50% by weight
of the therapeutic agent prior to post-processing, and the
coating comprises greater than 50% by weight of the
therapeutic agent after post-processing.
App. Br. 10 (Claims Appendix) (emphasis added).
The Examiner sets forth the following rejections in the Answer
entered December 2, 2016 (“Ans.”)3:
I. Claims 1, 2, 4—10, and 16—22 under 35 U.S.C. § 103(a) as
unpatentable over Tuch (US 2008/0051871 Al, published February 28,
2008)4;
3 The Examiner indicates that the grounds of rejection set forth in the
Answer are not new grounds of rejection, but are modified relative to the
grounds of rejection set forth in the Final Office Action entered October 7,
2015 (“Final Act.”) in response to Appellant’s cancellation of claim 3 in the
amendment filed December 7, 2015. Ans. 2, 7.
4 Although the Examiner states that this rejection is under § 102(b), we
interpret this rejection as an obviousness rejection under § 103(a) rather than
an anticipation rejection under § 102(b), in light of the Examiner’s
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Application 13/926,515
II. Claims 11—14 under 35 U.S.C. § 103(a) as unpatentable over
Tuch in view of Lavelle (US 2007/0078446 Al, published April 5, 2017) as
evidenced by El https://en.wikipedia.org/wiki/Polyethelyene glycol; and
III. Claim 15 under 35 U.S.C. § 103(a) as unpatentable over Tuch
in view of Lavelle and Zhao (US 2010/0233236 Al, published September
16, 2010) as evidenced by El.
DISCUSSION
Upon consideration of the evidence relied upon in this appeal and
each of Appellant’s contentions, we reverse the Examiner’s rejections of
claims 1, 2, and 4—22 under 35 U.S.C. § 103(a) for the reasons set forth in
the Appeal Brief and below.
Rejection I
We need only consider claim 1 because the remaining claims on
appeal include all the limitations of claim 1. As set forth above, claim 1
requires the recited method of forming a coated medical device to comprise,
inter alia, applying to an outer surface of a medical device a coating that
includes a therapeutic agent dispersed in a matrix of a polymer or oligomer
excipient, and selectively removing a substantial portion of the polymer or
oligomer excipient from the matrix in which the therapeutic agent is
dispersed by immersing the medical device in a solvent or solution.
Appellant’s Specification explains that this “post-processing” procedure of
immersing the coated medical device controls selective removal of the
placement of this rejection under the heading “Claim Rejections — 35 USC
§ 103” and the Examiner’s explicit indication that “there are no longer any
102 rejections remaining in the current application.” Ans. 2—3, 7.
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Application 13/926,515
coating matrix excipient relative to the therapeutic agent, and allows a
significantly higher amount of the coating matrix excipient than the
therapeutic agent to be removed from the coating. Spec. 125.
The Examiner finds that Tuch discloses applying to the exterior of a
medical device a coating that “may contain a polymer, and a drug applied at
the same time as the polymer (examples), and a pore-forming agent.” Ans. 3
(citing Tuch || 37—39, examples). The Examiner finds that because Tuch
discloses that the ratio of the pore-forming agent to the polymer may be 9:1,
the pore-forming agent reasonably functions as a matrix material. Ans. 3
(citing Tuch 143). The Examiner finds that Tuch discloses removing the
pore-forming agent. Ans. 3. The Examiner further finds that paragraph 62
of Tuch “makes clear” that “the starting solution for their entire invention”
includes a solvent, a polymer dissolved in the solvent, and a therapeutic
agent dispersed in the solvent. Ans. 8. The Examiner finds that all
embodiments of Tuch are not required to be porous, but if a pore-forming
agent is utilized, “it seems implied that it is to be part of this” starting
solution described in paragraph 62. Id.
However, Tuch’s disclosure as a whole describe two main aspects of
Tuch’s invention. The first aspect relates to a medical device coated with a
porous material that includes a therapeutic agent. Tuch || 15—17, 34; Fig. 2.
Tuch discloses that the porous material can be in the form of a sheet. Tuch
137. Tuch discloses forming such a porous sheet by dissolving a polymer,
such as polyether urethane, in an organic solvent, adding a particulate
material to the solution that is insoluble in the organic solvent, such as
sodium chloride or sucrose, casting the solution including the particulate
material into a thin film, and applying a second solvent, such as water, to
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Application 13/926,515
dissolve and remove the particulate material. Tuch 140. Tuch discloses
loading the porous polymeric sheet material thus formed with a therapeutic
agent by immersing the material in a solution or dispersion of the therapeutic
agent in a solvent, allowing the solution or dispersion to fill the pores, and
evaporating the solvent, which results in dispersion of the therapeutic agent
within at least a portion of the pores. Tuch | 52. Tuch exemplifies this
aspect of his invention in Example 1. Tuch || 68—70.
As Appellant points out, this first aspect of Tuch’s invention does not
involve applying to an outer surface of a medical device a coating that
includes a therapeutic agent dispersed in a matrix of a polymer or oligomer
excipient, and selectively removing a substantial portion of the polymer or
oligomer excipient from the matrix in which the therapeutic agent is
dispersed, as require by claim 1. App. Br. 4—5. Although the Examiner
finds that Tuch discloses removing the pore-forming agent from the
polymeric material, Tuch discloses removing the pore-forming agent before
loading the therapeutic agent into the polymeric material in order to create
pores in the material that will contain the subsequently loaded therapeutic
agent. Tuch || 40, 52.
The second aspect of Tuch’s invention relates to a method of coating
an intravascular stent with a therapeutic substance that involves applying to
the body of a stent a solution including a solvent, a polymer dissolved in the
solvent, and a therapeutic substance dispersed in the solvent, and
evaporating the solvent, to form a coating of the polymer and therapeutic
substance on the surface of the stent. Tuch || 23, 62—63. Tuch exemplifies
this aspect of his invention in Examples 4—8. Tuch H 73—77.
As Appellant correctly argues, Tuch does not disclose including a
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pore-forming agent in the stent coating of this second aspect of Tuch’s
invention. Reply Br. 4. Although as discussed above the Examiner asserts
that Tuch implies that a pore-forming agent could be included in the stent
coating solution, the Examiner does not point to any disclosures in Tuch,
other than paragraph 62, to support this assertion. We find no disclosure in
paragraph 62 implying that a pore-forming agent could be used in the stent
coating described in this paragraph. Nor do we find any such disclosure in
the remaining portions of Tuch.
In view of Tuch’s separate discussion and exemplification of first and
second aspects of Tuch’s invention (described above), and lack of any
disclosure indicating that the pore-forming agent of the first aspect could be
used in the coating solution of the second aspect, one of ordinary skill in the
art reasonably would have interpreted Tuch’s disclosures as a whole to
indicate that the first and second aspects of Tuch’s invention are
independent. The Examiner fails to provide a persuasive explanation
supported by evidence of why one of ordinary skill in the art would have
understood otherwise. Therefore, the Examiner fails to establish that Tuch
would have suggested applying to an outer surface of a medical device a
coating that includes a therapeutic agent dispersed in a matrix of a polymer
or oligomer excipient, and selectively removing a substantial portion of the
polymer or oligomer excipient from the matrix in which the therapeutic
agent is dispersed, as require by claim 1.
We accordingly do not sustain the Examiner’s rejection of claims 1, 2,
4—10, and 16—22 under 35 U.S.C. § 103(a) as unpatentable over Tuch.
Rejections II and III
We do not sustain these rejections because the Examiner does not rely
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Application 13/926,515
on Lavelle, Zhao, and/or El for any disclosure that remedies the deficiencies
of Tuch.
DECISION
We reverse the Examiner’s rejections of claims 1, 2, and 4—22 under
35 U.S.C. § 103(a).
REVERSED
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