Ex Parte Michal et al

Patent Trial and Appeal Board

Nov 17, 2017

14032336 (P.T.A.B. Nov. 17, 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.
14/032,336 09/20/2013 Eugene T. Michal 2209-3 CIP II DIVCON 8852
31554 7590 11/21/2017
CARTER, DELUCA, FARRELL & SCHMIDT, LLP
445 BROAD HOLLOW ROAD
SUITE 420
MELVILLE, NY 11747
EXAMINER
PARK, HAEJIN S
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
11/21/2017 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 EUGENE T. MICHAL,
DANIEL J. LERNER, and MATTHEW J. POLLMAN
Appeal 2017-001271
Application 14/032,336
Technology Center 1600
Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN, and
RYAN H. FLAX, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134(a) involving claims to a
catheter assembly. The Examiner rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.
Statement of the Case
Background
The Specification discloses “a novel approach to coating an
expandable structure of a medical disposable device, such as a balloon of a
balloon catheter, which can be used for local therapeutic agent delivery to
the surface of body lumens” (Spec. 14).
1 Appellants identify the Real Party in Interest as The Spectranetics
Corporation (see App. Br. 1).
Appeal 2017-001271
Application 14/032,336
The Claims
Claims 21—29 and 31—39 are on appeal. Independent claim 21 is
representative and reads as follows:
21. A catheter assembly comprising:
an expandable structure having an outer surface;
a non-durable coating comprising a polymer matrix
complexed with iodine disposed on the outer surface of the
expandable structure; and
an aqueous soluble therapeutic agent dispersed
throughout the polymer matrix.
The Issue
The Examiner rejected claims 21—29 and 31—39 under 35 U.S.C.
§ 103(a) as obvious over Kerrigan2 (Final Act. 3—5).
The Examiner finds Kerrigan teaches “catheters comprising (i) an
expandable structure such as balloons and stents, (ii) a ‘polymeric
component’ which includes a non-durable or biodegradable polymer coating,
(iii) iodine complexed on the surface of the polymeric component, and (iv)
further combined with an aqueous soluble drug” (Final Act. 4).
The Examiner acknowledges that Kerrigan does not exemplify “the
embodiment in which the active agent or the active agent and the
noncovalently bound iodine is/are dispersed throughout the polymer matrix”
(Id.).
However, the Examiner finds “Kerrigan teaches providing the active
agent not only on the coating surface, but also in a drug reservoir layer, i.e.,
2 Kerrigan et al., US 2009/0285874 Al, published Nov. 19, 2009.
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Application 14/032,336
a layer comprising a blend of polymer and active agent, beneath the coating
layer” (Id. at 5).
The Examiner finds it obvious to “modify Kerrigan’s polymeric
component that has iodine and a water-soluble drug coating to incorporate
the active agent throughout the polymer coating” (Final Act. 4) because
Kerrigan teaches “[t]he drug reservoir layer can be a polymer free drug layer
or can include a combination of [sic] a drug and polymer which have been
mixed, blended, bonded or conjugated” (Final Act. 4 citing Kerrigan 131;
emphasis omitted).
The issue with respect to the rejection is: Does the evidence of record
support the Examiner’s conclusion that Kerrigan suggests “an aqueous
soluble therapeutic agent dispersed throughout the polymer matrix” as
required by claims 21 and 31?
Findings of Fact
1. Kerrigan teaches:
a drug coated medical device, e.g., stent or balloon, is provided
. . . The iodine, iodide, iodate, the complex or salt thereof can
be dissolved in a solvent and applied to the surface of the
device. The solvent can be removed prior to the application of
the charged drug to the device. Alternatively, the surface of the
device is wet during the application of the charged drug to the
device.
(Kerrigan^ 15).
2. Kerrigan teaches “applying iodine, iodide, iodate, a complex or
salt thereof to the surface of the device” (Kerrigan 115).
3. Kerrigan teaches “applying a treatment material including a
halogen ... to the polymeric component; grounding the polymeric
component or applying a charge to the polymeric component; and applying a
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Application 14/032,336
charged drug to the polymeric component such that the drug is
electrostatically deposited on the stent” (Kerrigan 117).
4. Kerrigan teaches a ‘“polymeric component’ is intended to
include the whole body of the balloon, a part of the body of the balloon, the
outermost layer of the balloon, and/or the coating supported on the balloon
body substrate” (Kerrigan 131).
5. Kerrigan teaches:
The coating can alternatively be a top-coat layer deposited on a
drug reservoir layer to, for example, reduce the rate of release
of the drug. The drug reservoir layer can be a polymer free
drug layer or can include a combination of [] a drug and
polymer which have been mixed, blended, bonded or
conjugated.
(Kerrigan 131).
6. Kerrigan teaches a method that includes “applying a charged
polymer contemporaneously with the application of the charged drug . . .
The therapeutic agents can also include anti-inflammatory, antineoplastic,
antiplatelet, anti-coagulant, anti-fibrin, antithrombotic, antimitotic,
antibiotic, antiallergic and antioxidant compounds” (Kerrigan 116).
7. Kerrigan teaches “a combination of a polymer and a drug can
be electrostatically coating on the polymeric component of the stent”
(Kerrigan 143).
8. Kerrigan teaches the “polymeric component can be durable,
biodegradable, bioerodable, or bioabsorbable” (Kerrigan 133).
9. Kerrigan teaches:
Examples of drugs that can be coated on stents using the
method of the present invention include any moiety capable of
contributing to a therapeutic effect, a prophylactic effect, both a
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Application 14/032,336
therapeutic and prophylactic effect, or other biologically active
effect in a mammal. An agent can also be coated which has a
diagnostic property.
(Kerrigan 145).
10. Kerrigan teaches: “Examples of diagnostic agents include
radioopaque materials and include, but are not limited to, materials
comprising iodine or iodine-derivatives” (Kerrigan 1 52).
11. Kerrigan teaches:
In some embodiments the treatment composition includes a
halogen, halide, or a complex or salt thereof. Iodine, bromine,
chlorine and fluorine can be used. In the most preferred
embodiment, iodine, iodide, or iodate is used. Complexes of
halogen or halides can include those with biobeneficial
polymers such as polyethylene glycol (PEG). PEG is a well
know bio-friendly polymer that has been reported to have
beneficial use with stents.
(Kerrigan 137).
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 3—5; FF 1—11) and agree that
the claims are obvious over Kerrigan. We address Appellants’ arguments
below.
Appellants contend:
Kerrigan’s approach to achieving electrostatic coating on a non-
conductive device is a four step process that essentially
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Application 14/032,336
includes: 1) mounting the device; 2) applying iodine to the
mounted device; 3) grounding or charging the iodine covered
device; and 4) applying a charged drug to the grounded (or
charged), iodine covered device. None of these steps discloses
or suggests: 1) a catheter assembly including “a non-durable
coating comprising a polymer matrix complexed with iodine”
and “an aqueous soluble therapeutic agent dispersed throughout
the polymer matrix” as presently recited in claim 21; or 2) a
catheter assembly including “a nondurable coating comprising a
polymer matrix” and “an aqueous soluble therapeutic agent and
non-covalently bound iodine dispersed throughout the polymer
matrix” as recited in claim 31.
(App. Br. 5).
We do not find this argument persuasive. Kerrigan teaches “a drug
coated medical device” including stents with expandable balloons (FF 1)
that are coated with a biodegradable polymeric component (FF 8) that may
be treated with a halogen such as iodine (FF 2—3) as well as therapeutic
agents that “can include a combination of the a drug and polymer which
have been mixed, blended, bonded or conjugated” (FF 5). In particular,
Kerrigan teaches a polymer matrix that is in some sort of “complex” with
iodine when teaching “applying a treatment material including a halogen . . .
to the polymeric component” (FF 3) because the iodine is associated with
the polymer and the term “complex” is defined as a “molecular entity
formed by loose association involving two or more component molecular
entities (ionic or uncharged), or the corresponding chemical species.”3
3IUPAC. Compendium of Chemical Terminology, 2nd ed. (the “Gold
Book”). Compiled by A. D. McNaught and A. Wilkinson. Blackwell
Scientific Publications, Oxford (1997) (see https://goldbook.iupac.org/html/
C/CO 1203.html).
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In addition, Kerrigan directly suggests a coating with “a combination
of [] a drug and polymer which have been mixed, blended” (FF 5) where the
drug may comprise therapeutic agents (FF 6) or diagnostic agents (FF 9) and
“diagnostic agents include . . . materials comprising iodine” (FF 10). Thus,
Kerrigan reasonably suggests each of the elements required by claim 21, in
particular suggesting a non-durable coating (FF 8) comprising a polymer
with iodine (FF 9-10) that can mixed or blended (FF 5) and applied to the
outer surface of a balloon stent (FF 1 4). We, therefore, agree with the
Examiner that “Kerrigan discloses that the iodine may be coated onto the
devices just as a drug is” (Ans. 3).
Appellants contend “Kerrigan’s drug reservoir layer may, indeed,
possess a combination of a drug and polymer. However, nothing in this
passage suggests that both iodine and an active should be contained within
a polymer matrix as recited in Applicant’s claims” (App. Br. 7). Appellants
contend:
there is no basis to conclude that one skilled in the art would be
motivated to incorporate iodine into the drug reservoir layer of
the substrate to be electrostatically coated, because doing so has
not been shown to predictably achieve Kerrigan’s goal of
permitting electrostatic application of an additional charged
drug.
(Id.).
We are not persuaded. Kerrigan teaches complexes that comprise
halides such as iodine, polymers and charged drugs (FF 3), complexes of
drug and polymer (FF 5), complexes of iodine and polymers such as PEG
(FF 11). Moreover, Kerrigan specifically teaches combination of agents
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Application 14/032,336
with therapeutic and diagnostic efficacy (FF 9) and teaches a variety of
therapeutic agents (FF 6) and iodine as a diagnostic agent (FF 10).
In addition, Kerrigan teaches that iodine may be applied to stent or
balloon surfaces in a solvent that remains during application of the drug to
the device (FF 1), further evidencing the predictability of combining active
agents, iodine, and polymers on the surface of a stent or balloon. Thus, we
agree with the Examiner’s findings (see Ans. 6) and the Examiner’s
conclusion that
one having ordinary skill in the art at the time of the invention
would have understood that according to Kerrigan’s teachings,
a composition comprising a drug, a polymer, and iodine, or at
the least compositions comprising dmg+polymer and
iodine+polymer, may be electrostatically deposited onto a
polymeric component on a balloon.
(Ans. 7).
Appellants contend: “[cjontrary to the Office’s position, Kerrigan’s
iodine is present in a separate layer; it is not incorporated in a polymer
matrix that also includes a therapeutic agent incorporated therein” (App. Br.
8).
We find this argument unpersuasive. While Appellants are correct
that Kerrigan does not clearly anticipate the claims, Kerrigan teaches iodine
complexed with polymers such as PEG (FF 11) and Kerrigan recognizes the
equivalence of iodine as a diagnostic agent (FF 10) and other drugs as
therapeutic agents (FF 9) for disposal on the surface of the stent. Therefore,
we agree with the Examiner that:
even though Kerrigan does not expressly teach a working
example in which the active agent and iodine are both dispersed
throughout the polymer matrix, as noted above Kerrigan also
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Application 14/032,336
expressly teaches iodine as a diagnostic agent that may be
coated onto the medical devices separately from the “treatment
composition” (paras. 0045, 0052), and coating comprising a
combination of drug, polymer, and “other agents” or “other
materials”.
(Ans. 8).
Appellants contend “Kerrigan’s grounding or charging the iodine
covered device and then applying a charged drug to the grounded (or
charged), iodine covered device, does not provide motivation to one skilled
in the art to apply a coating with iodine, drug and polymer matrix in a single
layer” (App. Br. 9; cf. Reply Br. 2).
We find this argument unpersuasive because claim 21 does not require
the coating of iodine, drug, and polymer matrix to be in a single layer. See
In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (“Appellant’s arguments fail
from the outset because . . . they are not based on limitations appearing in
the claims.”)
While claim 31 may imply a single layer, without an explicit
requirement, we still find the argument unpersuasive because, as already
noted, Kerrigan recognizes the equivalence of iodine as a diagnostic agent
(FF 10) and other drugs as therapeutic agents (FF 9) for disposal on the
surface of the stent. To the extent that Appellants imply an express
suggestion from the reference is required, the “obviousness analysis cannot
be confined by the formalistic conception of the words teaching, suggestion,
and motivation, or by overemphasis on the importance of... the explicit
content of issued patents.” KSR, 550 U.S. at 419. Therefore, based on the
disclosures in Kerrigan outlined above, we agree with the Examiner that the
ordinary artisan interested in performing diagnosis and therapy would have
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Application 14/032,336
reasonably combined both agents into a single polymer to allow combined
diagnosis and therapy. This combination is merely a “predictable use of
prior art elements according to their established functions.” KSR, 550 U.S. at
417. No secondary consideration evidence for the combination has been
provided that would rebut the Examiner’s prima facie case of obviousness.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Kerrigan suggests “an aqueous soluble therapeutic agent dispersed
throughout the polymer matrix” as required by claims 21 and 31.
SUMMARY
In summary, we affirm the rejection of claims 21 and 31 under 35
U.S.C. § 103(a) as obvious over Kerrigan. Claims 22—29 and 32—39 fall
with claims 21 and 31.
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
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