Ex Parte Cole et al

Patent Trial and Appeal Board

Jan 31, 2017

13790568 (P.T.A.B. Jan. 31, 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.
13/790,568 03/08/2013 Mary L. Cole C00001206.USU2/LG10126 9131
27581 7590 02/02/2017
Medtronic, Inc. (CRDM)
710 MEDTRONIC PARKWAY NE
MS: LC340 Legal Patents
EXAMINER
STICE, PAULA J
MINNEAPOLIS, MN 55432-9924 ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
02/02/2017 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):
medtronic_crdm_docketing @ c ardinal-ip .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARY L. COLE, JONATHAN M. EDWARD, and
KEVIN R. SEIFERT
Appeal 2015-002203
Application 13/790,5681
Technology Center 3700
Before LINDA E. HORNER, THOMAS F. SMEGAL, and
JEFFREY A. STEPHENS, Administrative Patent Judges.
SMEGAL, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Mary L. Cole et al (Appellants) seek our review under 35 U.S.C.
§ 134 of the Examiner’s final rejection under 35 U.S.C. § 103(a) of claims
1—9 and 11—13 as unpatentable over Carlton (US 2009/0204192 Al, pub.
Aug. 13, 2009) and Edwin (US 2002/0095205 Al, pub. July 18, 2002); of
claims 14 and 15 over Carlton, Edwin, and Sage (US 2005/0021119 Al,
pub. Jan. 27, 2005); and of claims 16 and 17 over Carlton, Edwin, and
1 According to Appellants, the real party in interest is Medtronic, Inc.
Appeal Br. 3.
Appeal 2015-002203
Application 13/790,568
Helland (US 5,628,780, iss. May 13, 1997).2 We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
CLAIMED SUBJECT MATTER
Claim 1, the sole independent claim, is reproduced below and
illustrates the claimed subject matter, with disputed limitations emphasized.
Claim 1: A radiopaque marker comprising:
a body being adapted to be disposed around a portion of
an implantable medical lead and formed from a polymer mixed
with a radiopacifier,
wherein the polymer is designed to form a symbol that
identifies the implantable medical lead as being designed for safe
application of a medical procedure.
ANALYSIS
Obviousness of Claims 1—9 and 11—13 over Carlton and Edwin
The dispositive issue in this case is whether a radiopaque marker,
formed from a polymer mixed with a radiopacifier, intended for use in
identifying an implanted medical lead, would have been obvious to one of
ordinary skill in the art when a radiopacifier that is not mixed with a
polymer is admitted to be known for use in identifying the location of an
implanted medical lead.
Claims 1, 7—9, 11, and 12
Appellants argue claims 1, 7—9, 11, and 12 together in contesting the
rejection of these claims as obvious over Carlton and Edwin. See Appeal Br.
2 In an Amendment filed January 23, 2014, Appellants confirmed that Claim
10 had been canceled.
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4—7; Reply Br. 2^4. We select claim 1 as the representative claim for this
group, and the remaining claims stand or fall with claim 1. See 37 C.F.R.
§ 41.37(c)(l)(iv). Appellants present arguments under separate headings for
claims 2—6 and 13 (Appeal Br. 7—9; Reply Br. 4), which we address infra.
Regarding claim 1, the Examiner finds that Carlton discloses a
radiopaque marker, inter alia, with a body 126 formed of a radiopacifier that
is “adapted to be disposed around a portion of an implantable medical lead,”
where “the radiopacifier identifies the implantable medical lead as being
designated for safe application of a medical procedure.” Final Act. 3 (citing
Carlton, || 54—56; Figs. 9-13). While observing that “Carlton does not
specifically disclose that the radiopaque [body] is formed of a polymer
mixture with a radiopacifier,” the Examiner finds that Edwin “teaches a
similar device in which a radiopacifier [] is comprised of a polymer
including polyurethane and polyester and a metal [radiopacifier] of tungsten
and/or platinum. Id. at 4 (citing Edwin, 113). Based on the foregoing
factual analysis, the Examiner reasons that it would have been obvious “to
modify Carlton to include a polymer of polyurethane and/or polyester with
tungsten and/or platinum, as taught by Edwin, in order to coat an implant
with a radiopaque material.” Id. (citing Edwin, abstract).
Appellants do not dispute that Carlton discloses a radiopacifier
“disposed around a portion of an implantable metal lead,” as recited by
claim 1, while observing that “among the techniques disclosed in Carlton for
placing the marking 126, only a surface marking seems even potentially
relevant.” Appeal Br. 5. However, Appellants contend “it is unclear how,
based on Edwin, the Examiner proposes to turn a radiopaque surface
marking [126] into a body ‘formed from a polymer mixed with a
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Application 13/790,568
radiopacifier, ’ because Edwin discloses laying a coating of radiopaque
material on a polymer,” further observing that “the only thing that is
different between Edwin and Carlton is that the underlying structure being
marked may be made of a polymer in Edwin.” Id. Appellants also assert
that “the Examiner provides no explanation as to why the inclusion of a
polymer in (or on?) the lead of Carlton allows for the coating of an implant
with a radiopaque material in a way that was not previously achievable by
the techniques of Carlton,” pointing out that “the inclusion of a polymer
within (or on) the lead of Carlton makes little sense since Carlton already
includes, in at least one example, a surface marking (or coating).” Id.
The Examiner first explains that “Carlton is clearly disclosing all of
the claimed elements, including the radiopaque marker, as described in the
claim 1 rejection,” and that “Edwin is merely utilized to demonstrate that
using a mixed polymer in the form of polyurethane or polyester with
tungsten or platinum is known in the art.” Ans. 5. The Examiner continues
by explaining that “Edwin and Carlton have the same goal of using a
radiopaque marker, [while] in Edwin the concern is toxicity and therefore he
is choosing polymer/metal configurations that do not leach into the system
(paragraph [0009]),” concluding that “it is clearly obvious to combine these
arts in that it results in a simpl[e] swap of materials to increase
biocompatibility and to cut down in toxicity.” Id. at 5—6.
Appellants respond that because “Edwin and Carlton disclose the
same radiopaque material, it is unclear how modifying Carlton [with Edwin]
as asserted by the Examiner would cut down on toxicity.” Reply Br. 4.
However, Appellants misread Edwin, which describes the toxicity problems
resulting from the use of a radiopaque band to assist in the tracking of a
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catheter, and describes “encapsulating” the radiopaque material in a polymer
as a solution to the problem. See Edwin, || 10-12. Thus, we are persuaded
by the Examiner’s reasoning regarding the teaching of Edwin that toxicity
can be reduced by replacing a portion of the radiopaque material with
polymer. “[I]f a technique has been used to improve one device, and a
person of ordinary 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 Int 7 Co. v. Teleflex Inc.,
550 U.S. 398,417 (2007).
After paraphrasing the Examiner’s reasoning, as set forth at page 2 of
the Final Action, regarding the disclosure in Edwin of “a polymer mixed
with a radiopacifier,” Appellants also contend that “a lay person, let alone
one of ordinary skill in the art, would not consider two elements that are in
discrete layers, as are the layers of radiopaque material and polymer in
Edwin, to have been mixed.” Appeal Br. 5—6.
In response, the Examiner explains that several dictionary definitions
of “mix,” are consistent with Appellants’ “disclosure [which] clearly states
that the loaded polymer3 can be mixed, blended or otherwise formed”
(quoting from the Specification, 137), and reasons that “therefore the
broadest reasonable interpretation of the word ‘mixed’ was considered to be
combining of substances to [form] a different substance or to add something
to something else.” Ans. 4. The Examiner concludes by explaining that
“Edwin discloses a radiopaque marker that is a sheet coated on one or both
surfaces with a radiopaque metal (abstract), [that] this is clearly combining
3 Paragraph 36 of the Specification also discloses that “body 52 is formed
from a polymer loaded with a radiopacifier.”
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and a different substance is [otherwise] formed, [while] it is also adding one
substance to another.” Id.
While disagreeing, Appellants merely contend that “[n]one of the
attempted rationalizations in the Examiner’s Answer changes the fact that
distinct layers of radiopaque material and polymer such as ePTFE in a
layered structure [in Edwin], does not constitute a mixture of a radiopacifier
and a polymer, as recited in [Appellants’] claims.” Reply Br. 3. Appellants
do not offer persuasive explanation or evidence supporting the argument that
the layered structure of Edwin is not mixed under the broadest reasonable
construction of the term. We are instructed that “[attorney’s arguments in a
brief cannot take the place of evidence.” In re Pearson, 494 F.2d 1399,
1405 (CCPA 1974) (citation omitted); see also In re De Blauwe, 736 F.2d
699, 705 (Fed. Cir. 1984) (holding that lawyer arguments and conclusory
statements which are unsupported by factual evidence are entitled to little
probative value).
We agree with the Examiner’s finding that Edwin teaches a polymer
mixed with a radiopacifier under the broadest reasonable interpretation of
that phrase. Edwin’s teaching of encapsulating radiopaque markers within
polymers flflf 12—13) teaches combining the two materials into one structure,
resulting in a structure formed of “mixed” materials. The claim does not
specify a degree to which these materials are mixed, such as being
“blended.”4
4 Appellants also argue Edwin does not teach “blended.” See Appeal Br. 6.
We do not reach this argument because the Examiner did not enter
Appellants’ proposed amendment to claim 1. See Advisory Action mailed
May 30, 2014. In an appeal under 35 U.S.C. § 134(a), it is the Examiner’s
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For the foregoing reasons, we discern no error in the Examiner’s
findings and sustain the Examiner’s unpatentability rejection of claims 1, 7—
9, 11, and 12 over Carlton and Edwin.
Claims 2—6
Appellants recite the additional limitations of dependent claim 2 and
contend that “the Examiner failed to assert that either Carlton or Edwin
discloses that the thick portions of the body appear more radiologically
dense during an imaging procedure.” Appeal Br. 7. Thus, Appellants argue
that “Carlton does not disclose or suggest that the base of the triangle in
marker 136 appears more radiologically dense (darker) than the tip,” but
“[ijnstead, [that] the base of the triangle simply appears wider, not darker.”
Id. at 8.
In response, the Examiner contends that the language of claim 2
disputed by Appellants does not limit the structure and is “clearly
functional.” Ans. 6. The Examiner further states that if the functional
language is given weight, in Carlton,
[i]f the letter E shape is embedded into the wall of the lead body
then the square surrounding the letter E can be considered to be
the radiopaque feature [and] the spaces between the lines
forming the letter E will certainly appear less dense and will
certainly also be less thick in that they are only comprised of the
polymer without the metal radiopaque.
Id.
Appellants contend in response that “the spaces between the lines
forming the letter E are devoid of radiopaque material, and therefore, cannot
reasonably be construed to be part of a body . . . ‘formed [from] a polymer
final rejection that we review. See In re Webb, 916 F.2d 1553, 1556 (Fed.
Cir. 1990).
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Application 13/790,568
mixed with a radiopacifier, wherein the polymer is designed to form a
symbol that identifies the implantable medical lead. . . ’ as recited by claim
1, from which claim 2 depends.” Reply Br. 4.
We agree with Appellants that the functional limitation recited in
claim 2 limits the structure. Although the letter “T” may be considered to
have varying “thickness” because it is wider at the top than the bottom, the
claim further recites that the thick portions appear more radiologically dense
during an imaging procedure, which limits the varying “thickness” to being
a variation of the depth of the symbol rather than the width.5 Thus, the
Examiner’s finding that Carlton’s symbols in the form of a triangle or the
letters “T” or “E” have varying thickness because of their varying width
(Final Act. 3) is not sufficient to meet the functional limitation of the claim.
In addition, we agree with Appellants that the Examiner’s alternative
explanation in the Answer as to the spaces in the letter “E” is not sufficient
to cure the noted deficiency. The evidence relied on by the Examiner does
not show that the spaces between the lines forming Carlton’s letter “E” are
thinner portions of the same body formed from a polymer mixed with a
radiopacifier, rather than simply the absence of material.
For the foregoing reasons, we do not sustain the Examiner’s
unpatentability rejection of claims 2—6 over Carlton and Edwin.
5 We interpret the claim to require that the thick portions of the body appear
more radiologically dense when the symbol is being viewed from plan view,
rather than a profile view from the side, which may not allow for
identification of the symbol.
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Claim 13
Regarding dependent claim 13, which further limits the radiopaque
marker of claim 1 to a “body [that] forms a lumen through which a lead can
pass through the radiopaque marker,” the Examiner finds that Edwin
“teaches that the polymer body forms a lumen.” Final Act. 4—5 (citing
Edwin, Figs. 1—3). Based on the disclosure of Edwin, the Examiner reasons
that it would have been obvious “to further modify Carlton/Edwin [as
applied to] claim 1 to include that the body of the polymer and metal could
form a lumen, as taught by Edwin, in order to have a radiopaque material
which is on the surface of an implantable medical device.” Id. at 5.
In response, Appellants first contend that in rejecting claim 1, “the
Examiner asserted that Carlton discloses a body adapted to be disposed
around a portion of an implantable medical lead,” and “[t]o rely on Edwin as
disclosing the body in the rejection of claim 13 is, therefore, inconsistent
with the rejection of claim 1.” Appeal Br. 8. In addition, Appellants assert
that “Edwin does not disclose that ‘the body of the polymer and metal could
form a lumen, ’ but rather that a graft that may be formed of ePTFE that has a
radiopaque coating on a portion of the graft.” Id. at 8—9. Appellants
conclude that “[o]ne of ordinary skill in the art would not be motivated to
modify Carlton based on the disclosure of Edwin, to create a radiopaque
marker [with] a body being adapted to be disposed around a portion of an
implantable medical lead and formed from a polymer mixed with a
radiopacifier, [with] the body forming a lumen through which a lead can
pass through the radiopaque marker, as recited in claim 13.” Id. at 8—9.
However, the Examiner explains that Carlton “has a symbol on the
exterior surface of the lead,” and finds that while “this symbol is not solid in
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any way, a lumen lies below this symbol.” Ans. 6—7. The Examiner
acknowledges that “[t]his may not be a complete lumen,” but reasons “that
aspect is clearly and unequivocally shown in Figures 1—2 of Edwin, [as]
element #20 is clearly forming a complete lumen.” Id. at 7. Appellants have
not apprised us of any error in the Examiner’s findings or conclusions, and
we find none.
For the foregoing reasons, we sustain the Examiner’s unpatentability
rejection of claim 13 over Carlton and Edwin.
Obviousness of Claims 14 and 15 over Carlton, Edwin, and Sage
Appellants argue claims 14 and 15 as a group. Appeal Br. 9-10. We
select claim 14 as representative.
Claim 14 further limits claim 13 by reciting that the lumen “body
includes a slit along the longitudinal length of the body.” The Examiner
finds that Sage teaches “a sleeve 240 which can be a radiopaque which clips
into 224 to form a seal.” Final Act. 5 (citing Sage, ^fl[ 65, 68; Fig. 15).
Furthermore, as to both claims 14 and 15, the Examiner reasons that it would
have been obvious
to modify Carlton/Edwin [as applied to claim 1 ] to include a slit
in the body along the longitudinal length which comprises a
mechanism to close at least a portion of the slit along the length
and maintain the marker at a location along the lead as taught by
Sage, in order to have a sleeve that has radiopaque qualities clip
onto an outer member to determine [the] location of the device
upon imaging.
Final Act. 5—6.
While contending that “Sage fails overcome the fundamental
deficiencies of Carlton in view of Edwin with respect to claim 1,”
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Appellants also argue that “claim 14 recites the additional feature of the
body including a slit along the longitudinal length of the body,” that “is
neither disclosed nor suggested by the applied art.” Appeal Br. 10.
However, without identifying where Carlton discloses the slit recited in
claim 14, and ignoring the limitations of claim 13 from which claims 14 and
15 depend, Appellants assert that “Carlton already includes the ability [to]
‘determine [the] location of the device upon imaging,’” and that “[o]ne or
(sic) ordinary skill in the art at the time of the invention would not look to a
secondary reference (Sage) to solve a problem already solved by the primary
reference (Carlton).” Id.
We agree with the Examiner that Appellants have not persuasively
responded to the final rejection, and also agree that it would be obvious “to
modify Carlton/Edwin to include a sleeve [of Sage] which would require a
slit.” Ans. 7. Thus we sustain the Examiner’s unpatentability rejection of
claims 14 and 15 over Carlton, Edwin, and Sage.
Obviousness of Claims 16 and 17 over Carlton, Edwin, and Helland
Other than observing that “Helland fails [to] overcome at least [the]
deficiency of Carlton in view of Edwin with respect to claim 1,” (Appeal Br.
10), we understand Appellants’ appeal of the rejection of claims 16 and 17
to rest on the arguments presented against the rejection of claim 1, which we
found not demonstrative of error in the Examiner’s rejection of claims 1, 7—
9, and 11—13 over Carlton and Edwin, as set forth supra. Thus, we sustain
the Examiner’s unpatentability rejection of claims 16 and 17 over Carlton,
Edwin, and Helland.
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DECISION
We AFFIRM the Examiner’s rejections of claims 1, 7—9, and 11—17.
We REVERSE the Examiner’s rejection of claims 2—6.
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)(l)(iv).
AFFIRMED-IN-PART
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