Ex Parte Kibbe et al

Patent Trial and Appeal Board

Jun 12, 2017

13641378 (P.T.A.B. Jun. 12, 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.
13/641,378 12/04/2012 Melina R. Kibbe 5369-00057 7223
26753 7590 06/14/2017
Andrus Intellectual Property Law, LLP
100 EAST WISCONSIN AVENUE, SUITE 1100
MILWAUKEE, WI 53202
EXAMINER
SCHALL, MATTHEW WAYNE
ART UNIT PAPER NUMBER
3738
NOTIFICATION DATE DELIVERY MODE
06/14/2017 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):
patentdocketing @ andruslaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MELINA R. KIBBE and GUILLERMO A. AMEER1
Appeal 2016-004409
Application 13/641,378
Technology Center 3700
Before FRANCISCO C. PRATS, ULRIKE W. JENKS, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims directed
to a stent. The Examiner rejects the claims as anticipated. We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 According to Appellants, the Real Party in Interest is Northwestern
University. Appeal Br. 1.
Appeal 2016-004409
Application 13/641,378
STATEMENT OF THE CASE
Claims 1 and 4—12 are on appeal, and can be found in the Claims
Appendix of the Appeal Brief. Claim 1 is representative of the claims on
appeal, and reads as follows:
1. A liquid cast biodegradable arterial stent, wherein the stent
comprises a biodegradable polymer and the stent is formed by
curing in situ a solution comprising prepolymers or monomers
that polymerize or cross-link to form the biodegradable polymer.
Appellants request review of the Examiner’s rejection of claims 1 and
4—12 as anticipated by Daniloff.2
The issue is: Does the preponderance of evidence of record support
the Examiner’s finding that Daniloff anticipates claim 1?
Findings of Fact
FF1. Daniloff teaches that “[cjrosslinkable compositions are provided that
readily crosslink in situ to provide crosslinked biomaterials.” Daniloff
Abstract. Compositions “can be injected or otherwise applied to a
specific site within a patient’s body, e.g., a site in need of
augmentation, and allowed to crosslink at the site of injection.” Id. 1
75.
Once inside the patient’s body, the reactive groups on the
components inter-react with each other to form a three-
dimensional matrix in situ. . . . some of the reactive
electrophilic groups may also react with primary amino
groups on lysine residues of collagen molecules within
the patient’s own tissue, providing for “biological
anchoring” of the composition with the host tissue.
Id. 1583.
2 Daniloff et al., US 2005/0281883 Al, published Dec. 22, 2005
(“Daniloff’).
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Application 13/641,378
FF2. Daniloff teaches that:
medical implants may be coated with, or otherwise
adapted to release or incorporate an agent which inhibits
the formation of reactive scar tissue on, or around, the
surface of the device or implant. . . . Compositions and
methods are described for coating medical devices and
implants with drug-delivery compositions.
Id. 1 628. “Examples of medical devices of particular utility for use
in combination with a fibrosis-inhibiting agent include, but are not
restricted to vascular stents.” Id. 1 630.
Principles of Law
“In determining validity of a product-by-process claim, the focus is on
the product and not the process of making it.” Amgen Inc. v. F. Hoffman-La
Roche Ltd., 580 F.3d 1340, 1369 (Fed. Cir. 2009). Nonetheless, “if the
process by which a product is made imparts structural and functional
differences distinguishing the claimed product from the prior art, then those
differences are relevant as evidence of no anticipation although they are not
explicitly part of the claim.” Greenliant Systems, Inc. v. XicorLLC, 692
F.3d 1261, 1268 (Fed. Cir. 2012) (internal quotations omitted). As the court
explained in Greenliant, “[consistent with our precedent, the Patent Office
in determining patentability considers the process in which a product is
formed if that process imparts distinctive structural characteristics . . . .”
Id. (citing MPEP § 2113) (emphasis added)
Analysis
The Examiner interprets that the claimed limitations of “liquid cast”
and “cured in situ” are product-by-process limitations and as such are “not
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Application 13/641,378
construed as being limited to the product formed by the specific process
recited.” Ans. 3. For the following reasons, we agree with the Examiner
that the recited limitations are product-by-process limitations.
We first turn to the preamble to determine if limitations therein are
necessary for the proper construction of the claim. We determine that the
preamble reciting “liquid cast” is not further limiting because it does not add
limitations to the body of the claim. “If the preamble adds no limitations to
those in the body of the claim, the preamble is not itself a claim limitation
and is irrelevant to proper construction of the claim.” IMS Technology, Inc.
v. Haas Automation, Inc., 206 F.3d 1422, 1434 (Fed. Cir. 2000). Here, the
body of the claim recites that the stent is formed by curing a solution (also
known as a liquid) of prepolymers and monomers. Thus, the preamble
reciting “liquid cast” does not add limitations to the body of the claim,
because the body of the claim already tells us to cure the solution and
thereby the preamble is not further limiting.
In addition, we also agree with the Examiner’s position that “liquid
cast” is reasonably interpreted to be a process limitation. “Liquid cast” tells
the relevant audience that the process involves the use of a liquid and mold.
As such, we agree with the Examiner position that the limitation “liquid
cast” as found in the preamble is a product-by-process limitation.
The Examiner also finds that the limitation “cured in situ” is also a
product-by-process limitation. We find no error with this interpretation as
well.
Based on the Examiner’s reasonable interpretation that the claim
terms “liquid cast” and “cured in situ” are product-by-process limitations,
the Examiner concludes that the claim is anticipated by a stent that is coated
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Application 13/641,378
with a biodegradable polymer. Ans. 2 (“[cjlaim 1 simply requires a stent
comprising a biodegradable polymer. A coating on a stent rejects this claim
language”); FF1 andFF2.
Appellants contend that curing the stent in situ imparts distinctive
structural characteristics to the stent. Appeal Br. 6. “[B]y forming the
claimed stent from pre-polymers and monomers that polymerize in situ, the
outer surface of the stent thus formed will mirror the interior of the arterial
wall and the stent will more precisely fit within the artery than a stent
formed from a polymer made ex situ and subsequently placed in the artery.”
Appeal Br. 14. Additionally, Appellants contend that a stent formed with a
polymer in situ will allow the polymer to chemically react with the inner
arterial wall to more firmly anchor the stent. See Id.', see also FF1
(“electrophilic groups may also react with primary amino groups on lysine
residues of collagen molecules within the patient’s own tissue, providing for
“biological anchoring” of the composition with the host tissue”).
We find that Appellants have the better position. Appellants have
directed us to structural differences between stent formed in situ versus
stents produced by other means. Specifically, a stent cured in place will take
on the shape of the environment in which the polymer is cured. The
Examiner’s response does not address the structural aspect raised by
Appellants. Because there are structural differences imparted to the product
by the process of making the product, we do not find anticipation based on
Daniloff. See Greenliant Systems, Inc. v. XicorLLC, 692 at 1268.
Accordingly, we reverse the anticipation rejection based on Daniloff.
REVERSED
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