Ex Parte Marron et al

Patent Trial and Appeal Board

Jul 14, 2016

12839949 (P.T.A.B. Jul. 14, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/839,949 07/20/2010
121974 7590 07118/2016
KACVINSKY DAISAK BLUNI PLLC
America's Cup Building
50 Doaks Lane
Marblehead, MA 01945
FIRST NAMED INVENTOR
Thomas Mark Marron
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
S63 .2P- l 467 4-US02 9209
EXAMINER
BOWMAN, ANDREW J
ART UNIT PAPER NUMBER
1717
NOTIFICATION DATE DELIVERY MODE
07/18/2016 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):
kddocketing@cpaglobal.com
Docketing@kdbfirm.com
bbonneville@kdbfirm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte THOMAS MARK MARRON,
MICHAEL SEAN OWENS, MARK STEVEN SMITH,
JAMES EDWARD LASCH, AMOD SHRIDHAR MOD AK,
and ANDY DUBEL1
Appeal2015-000923
Application 12/839,949
Technology Center 1700
Before GEORGE C. BEST, A VEL YN M. ROSS, and LILAN REN,
Administrative Patent Judges.
REN, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from a Rejection2 of
claims 1-12. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 The Real Party in Interest is identified as Boston Scientific Scimed, Inc.
(Appeal Brief, filed May 8, 2014 ("App. Br."), 3.)
2 Non-Final Office Action mailed January 21, 2014 ("Non-Final Rejection";
cited as "NFR"). The Examiner has previously issued multiple actions
including a Final Rejection dated August 2, 2013, a Non-Final Rejection
dated February 8, 2013, a Final Action dated November 5, 2012, and a Non-
Final Rejection dated July 18, 2012.
Appeal2015-000923
Application 12/839,949
A. Introduction3
OPINION
The subject matter on appeal relates to a system "for coating a
medical device such as a catheter, balloon or implantable prosthesis such as
a stent." (Spec. 2, 11. 31-33.) Figure 1 of the '949 Specification, providing a
frontal view of the system, is reproduced below:
Figure 1 of the '949 Specification
Figure 1 illustrates "coating system 1 O" which "comprises a transfer
web 20 and a metering web 30 .... " (Spec. 4, 11. 29-30.) As illustrated,
"transfer web 20 includes outside surface 21 and inside surface 23; metering
web 30 includes outside surface 31 and inside surface 33." (Id. at 7, 1. 33-8,
1. 1.) Figure 1 also illustrates "a medical device retaining mechanism 80 ...
suitable for mounting a medical device [] such as a stent, balloon, catheter or
3 Application 12/839,949, Medical Device Coating System, filed July 20
2010, claims the benefit of U.S. Provisional Patent Application No.
61/226,782, filed July 20, 2009 and the benefit of U.S. Provisional
Application No. 61/247,829, filed October 1, 2009. We refer to the
'"949 Specification," which we cite as "Spec."
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Application 12/839,949
catheter component, etc. thereon." (Id. at 17, 11. 13-16.) "[S]ource
mechanisms 22 and 32 are spools or rollers which have a predetermined
length of web contained thereon and the end mechanisms 24 and 34 are, at
least initially empty spools or rollers which receive the appropriate web 20
or 30." (Id. at 6, 11. 16-19.) Upon actuating the rollers, "the webs along the
respective transfer web pathway 25 and metering web pathway 35" may be
advanced. (Id. at 6, 11. 31-32.)
The '949 Specification states that "[b ]efore advancement of the webs,
or during a point when at least the transfer web 20 is not moving (stopped)
by a control mechanism (not shown), an initial quantity of coating solution
50 is deposited from an applicator onto an outside surface 21 of the transfer
web 20[.]" (Id. at 8, 11. 16-19.) "[T]he applicator 61 is a syringe. Once the
initial quantity of coating solution 50 is applied, the transfer web 20 is
advanced in order to move the solution 50 from the staging area to a
metering gap 54. The initial quantity of coating solution 50 is then passed
through the metering gap 54." (Id. at 9, 11. 5-8.) "The coating solution that
remains on the transfer web 20 after passing through the gap 54 defines a
coating patch 50a that will have a substantially uniform thickness across its
relevant working area 57." (Id. at 8, 11. 28-30.) "The working area 57 is the
area of the patch which will be subsequently brought into contact with a
medical device." (Id. at 8, 11. 30-31.)
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Application 12/839,949
Figure 6 is reproduced below:
Figure 6 of the '949 Specification
Figure 6 "is a detailed depiction of the gap [ 54] defined by the
metering web (via the blade) and the transfer web (via the base) shown in
FI Gs. 1-4 through which a quantity of coating solution is passed before
application onto a medical device." (Id. at 4, 11. 3-5.)
The '949 Specification states:
As illustrated in FIG. 6, the metering gap 54 is a
restriction wherein an outside surface 31 of the metering web
30 is brought into close proximity with the outside surface 21 of
the transfer web 20, such that when the initial quantity of
coating solution 50 is passed through the gap 54 at least some
amount of excess coating solution 50b will adhere to the
outside surface 31 of the advancing metering web 30 and be
transported away.
(Id. at 8, 11. 23-28.)
Representative claim 1 reads:
1. A system for applying a coating solution to a medical
device, the system comprising:
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Application 12/839,949
a transfer web, the transfer web defining an inside surface
and an outside surface, the transfer web extending along a
transfer web pathway, the transfer web being moveable in an
upstream and downstream direction along the transfer web
pathway;
a metering web, the metering web defining an inside
surface and an outside surface, the metering web extending along
a metering web pathway, the metering web separate and distinct
from the transfer web;
a coating deposition mechanism, the coating deposition
mechanism constructed and arranged to deposit a quantity of
coating solution onto a staging area, the staging area comprising
a region of the outside surface of the transfer web,
a metering gap, the metering gap being defined by the
outside surface of the transfer web and the outside surface of the
metering web, the metering gap being positioned downstream
from the staging area; and
a medical device support, the medical device support
positioned at a coating application region being defined by the
outside surface of the transfer web downstream from the
metering gap.
(Claims Appendix, App. Br. 29 (emphases added).)
The Examiner maintains the following grounds of rejection:4
A. Claims 1-3, 5, 6, 10, and 12 stand rejected under 35 U.S.C
§ 103(a) as being unpatentable over Voelker.5
Al. Claim 4 (dependent from claim 1) stands rejected under 35
U.S.C § 103(a) as being unpatentable over Voelker and
Allenberg. 6
4 Examiner's Answer mailed August 29, 2014 ("Ans.").
5 Walter D. Voelker, Polyurethane Foam Under Textile Fabric, U.S. Patent
No. 3,240,655 (issued March 15, 1966).
6 Kurt Allenberg, et al., Soft Orthopedic Casting Article With Reinforcement
System, U.S. Patent No. 5,913,840 (issued June 22, 1999).
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Application 12/839,949
A2. Claims 7-9 (dependent from claim 1) stand rejected under 3 5
U.S.C § 103(a) as being unpatentable over Voelker and TMI. 7
A3. Claim 11 (dependent from claim 1) stands rejected under 3 5
U.S.C § 103(a) as being unpatentable over Voelker and
Richard.8
B. Discussion
Findings of fact throughout this Opinion are supported by a
preponderance of the evidence of record.
Claim 19
With regard to the obviousness rejection of claim 1 based on Voelker,
the dispositive issue is whether the Examiner has shown that a system
having "a transfer web" and "a metering web" is present in or would have
been obvious in view of the applied prior art.
The reference Voelker "relates to the process and apparatus for
continuous production of a thin sheet of plastic foam adhered to sheet
material." (Voelker col. 1, 11. 11-14.) In particular, Voelker teaches:
[an] apparatus and method for applying a layer of plastic foam
forming materials whose thickness is precisely controlled to one
surface of a non-porous or impermeable sheet material, the
impermeable sheet is advanced through a foam thickness
controlling zone, and only after the foam has a predetermined
thickness and significant adhesiveness, placing in contact with
7 The TMI Group of Companies, K Paint Applicator, Copyright 2002
("TMI").
8 Robert E. Richard, Medical Devices Based on Modified Polyols, U.S.
Patent Application Publication No. 2008/0160062 Al (published July 3,
2008).
9 Claims 2, 6, and 12 stand or fall with claim 1. (See, e.g., App Br.)
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Application 12/839,949
the surface of the foam under controlled light pressure an upper
sheet material, whereby adhesion of the upper sheet material to
the foam is obtained. If such upper sheet material is a textile
fabric or other porous material, the penetration by the foam of
the porous surfaces of the sheet material may be precisely
controlled by this delayed laydown of the upper sheet material.
(Id. at col. 1, 11. 23-33.) Voelker's Figure 1 is reproduced below:
Figure 1 of Voelker
Figure 1 depicts a portion of an apparatus for securing foam to the
bottom of a sheet material. (Voelker col. 1, 11. 38-43.) In this apparatus, "an
impermeable sheet material 10 is power drawn through a series of zones
including a coating zone 11." (Id. at col. 2, 11. 1-3.) "The impermeable
sheet passes between metering rolls 12 and 13 and then through a loop 14,
including passage over rolls 15, 16, 17 and 18 before reentering the coating
zone 11." (Id. at col. 2, 11. 3-6.)
The Examiner finds that the upper portion of the "impermeable sheet
material 1 O" in Voelker teaches or suggests the claimed "metering web" and
that the lower portion of the sheet material 10 teaches or suggests the
claimed "transfer web." (NFR 3.) The Examiner finds that a skilled artisan
would have found the claimed structure obvious based on the teaching or
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Application 12/839,949
suggestion that Voelker' s sheet material 10 may function both as a transfer
and a metering web. (Ans. 4.)
Appellants, however, argue that there is no teaching or suggestion in
Voelker of an apparatus that includes both a transfer web and a metering
web. (App. Br. 17.) Appellants additionally argue the Examiner erred in
relying on Ex parte Rubin, 128 USPQ 440 (BPAI 1959) in finding
obviousness. (App. Br. 16.) Although the Examiner's obviousness analysis
does not include citations to MPEP 2144.04 or In re Dulberg, 289 F.2d 522
(CCPA 1961), Appellants assert that the rejection is in error also because the
Examiner misapplied "the theory of separating parts" under the MPEP and
Dulberg. (App. Br. 16.) Appellants further argue that "the legal theory of
duplication of parts also is not applicable" here. (Id. (citing Appeal Brief
submitted October 1, 2013 at 18-19 ("First Appeal").) 10 In the First Appeal
(which was not reviewed by us), Appellants argued that "the function
disclosed in Voelker for the impermeable sheet material 10 is a moveable
substrate for the formation, and transfer of, a foam material" which should
be distinguished from the function of "metering the amount of foam forming
chemicals on the impermeable sheet material 10." (First Appeal at 19.)
"[W]hen a patent claims a structure already known in the prior art that
is altered by the mere substitution of one element for another known in the
field, the combination must do more than yield a predictable result." KSR
Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). "[W]hen the question is
whether a patent claiming the combination of elements of prior art is
obvious," the answer depends on "whether the improvement is more than the
10 In response to the Appeal Brief filed October 1, 2013, a Non-Final
Rejection was issued on January 21, 2014.
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Application 12/839,949
predictable use of prior art elements according to their established
functions." Id. at 417.
In this case, Appellants distinguish cases such as Rubin and Dulberg
based on the facts but do not apply these cases to show why claim 1 is
patentable over Voelker. Appellants acknowledge that the apparatus in
Voelker includes a "sheet material 1 O" which may "pass[] between metering
rolls 12 and 13" and that "the thickness of the deposited film of chemicals is
further regulated by adjusting space between the metering rolls 12 and 13."
(App. Br. 14 (citing Voelker col. 2, 11. 9-15).) Appellants do not argue that
the Examiner erred in finding that "Voelker essentially runs his web upside
down during the first portion of the coating operation so as to use a portion
of the web to meter the coating thickness that is applied to the web further
downstream as an alternative to supply a completely different web system
for the metering that is separate from the web that [is] to be coated." (NFR
4; App. Br. 17.) Appellants do not argue that the Examiner erred in finding
that using Voelker' s sheet material 10 as both a transfer web and a metering
web would have been a "predictable use of prior art elements according to
their established functions." (See NFR 4; see also KSR, 550 U.S. at 417.)
Thus, claiming a mere plurality of prior art elements is not an unobvious
distinction over the prior art of record, because using plural elements would
have produced a predictable result under section 103. 11
11 Appellants also argue in passing that Voelker is not related to a medical
device. (Appeal Br. 15.) Appellants, however, do not argue that the
preamble statement that the system is "for applying a coating solution to a
medical device" is more than a purpose or intended use. Such a statement of
intended use does not impart patentability to apparatus claims when it does
not recite, as is the case here, structure or functional features that distinguish
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In the Reply Brief (Reply Br. 2--4 ), 12 Appellants argue that the
claimed apparatus should be distinguished from that of Voelker because the
claimed apparatus may "regulate coating thickness" so that the claimed
apparatus may "coat a medical device with a coating of uniform thickness."
(Id. at 3.) Appellants' argument is flawed for at least two reasons. First,
Appellants' principal brief provides that Voelker' s apparatus may also be
used for "the thickness of the deposited film of chemicals [to be] ...
regulated[.]" (App. Br. 14 (citing Voelker col. 2, 11. 9-15).) Second, claim 1
does not recite the purported function of coating thickness control, and we
decline to import into the claim limitations that are not recited. Phillips v.
AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005).
To the extent that Appellants advance new arguments in the Reply
Brief (Reply Br. 2--4) not in response to a shift in the Examiner's position in
the Answer, we note that "[a ]ny bases for asserting error, whether factual or
legal, that are not raised in the principal brief are waived." In re Hyatt, 211
F.3d 1367, 1373 (Fed. Cir. 2000) (noting that an argument not first raised in
the Brief to the Board is waived on appeal); Ex parte Nakashima, 93
USPQ2d 1834 (BP AI 2010) (informative) (explaining that arguments and
evidence not timely presented in the principal Brief will not be considered
when filed in a Reply Brief, absent a showing of good cause explaining why
the argument could not have been presented in the Principal Brief); Ex parte
Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (informative).
over the prior art. See Catalina Mktg. Int'!, Inc. v. Coolsavings.com, Inc.,
289 F.3d 801, 809 (Fed. Cir. 2002).
12 Reply Brief filed October 22, 2014 ("Reply Br.").
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Application 12/839,949
Claim 3
Claim 3 depends from claim 1 and additionally recites "a blade, the
blade comprising an edge, the metering web pathway extending around at
least a portion of the edge, the inside surface of the metering web contacting
the at least a portion of the edge along an edge line."
Based on the figures in the '949 Specification, the Examiner construes
the term "blade" to include a "doctor blade" which may have a "rounded
edge." (NFR 5; Ans. 5.) Under this claim construction, the Examiner finds
that a skilled artisan would have found claim 3 obvious in view of the
"rounded roller of the prior art Voelker" which includes an outer edge and
an edge line. (NFR 5; see also Ans. 5 (citing Figure 1 of Voelker and roller
12).)
Appellants do not dispute the Examiner's construction of the term
"blade" but faults the Examiner for failing to "provide[] extrinsic evidence"
in support of the claim construction. (App. Br. 18; see also Reply Br. 4.)
Appellants also argue that the Examiner erred by relying "on function rather
than recited structure in the rejection of claim 3." (App. Br. 18 (emphasis in
original).)
When claim terminology is construed during prosecution, claims are
given their broadest reasonable interpretation consistent with the
specification, reading claim language in light of the specification as it would
be interpreted by one of ordinary skill in the art. In re Am. A cad. of Sci.
Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). In this case, the Examiner
has construed the term "blade" based on the '949 Specification including the
drawings. (See NFR 5 (citing to figures of the '949 Specification); Ans. 5
(citing Figure 6 of the '949 Specification).) While the Examiner has set
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forth a broad but reasonable interpretation of the claim language, Appellants
have not pointed to any definitions or disavowals in the specification or
otherwise clearly explained why the Examiner's interpretation is
unreasonable or inconsistent with the '949 Specification. Appellants have
not provided an explanation, supported by evidence in the record, why claim
3 should be patentably distinguished from the apparatus in Voelker either
based on the Examiner's claim construction or Appellants own construction.
No harmful error has therefore been shown with regard to the rejection of
claim 3.
Claim 5
Claim 5 depends from claim 1 and additionally recites that the "initial
quantity of coating solution applied to the transfer web defines a barbell-like
shape."
The Examiner finds that a skilled artisan, based on the chemical
solution applied by roller 12 in Voelker, would have found claim 5 obvious
because a change in shape is generally considered obvious and the prior art
teaches or suggests "the same coating shape" formed by roller 12. (NFR 5;
Ans. 5-6.)
Appellants does not address the Examiner's conclusion that a change
in shape alone is insufficient to show patentablity. (See App. Br. 19-20;
Reply Br. 5-6.) Appellants instead cite Figure 1 of Voelker and argue that
the figure shows that "Voelker does not teach or suggest that the mixing
head 19 applies the foam forming chemicals to the sheet material 10 in a
barbell shape." (App. Br. 20; see also Reply Br. 6.)
A change of shape does not make a product nonobvious where the
claimed shape is not of functional significance and accomplishes the same
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purpose as the prior art shape. See Jn re Dailey, 357 F.2d 669, 672-73
(CCPA 1966). Appellants' argument in this case, solely based on the fact
that the prior art reference Voelker does not explicitly describe the coating
as "barbell" shaped, has not pointed us to harmful errors in the Examiner's
conclusion that a skilled artisan would have found a change in shape
obvious.
Claim 10
Claim 10 depends from claim 1 and additionally recites that "the
medical device support includes a medical device rotatably disposed
thereon, the medical device being positioned immediately adjacent to the
transfer web."
Appellants argue that the Examiner erred by failing to use the FDA
definition of "medical device." (App. Br. 22; see Reply Br. 7.) Appellants
also argue that the Examiner erred in finding that take up roll 30 illustrated
in Figure 2 of Voelker (reproduced below) as "a medical device support"
recited in claim 10. (App. Br. 23.)
Figure 2 of Voelker
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Voelker' s Figure 2 depicts a portion of an apparatus for securing foam
to the bottom of a sheet material. (Voelker col. 1, 11. 3 8--43.)
Appellants reason that because "take up roll 30 is not positioned at a
claimed 'coating application region,"' Figure 2 of Voelker does not teach or
suggest a "medical device support [that is] positioned at a coating
application region being defined by the outside surface of the transfer web
downstream from the metering gap ... the medical device being positioned
immediately adjacent to the transfer web" as recited in claim 10. (App. Br.
at 24; see Reply Br. 8.) The '949 Specification does not provide a definition
of "medical device." (See Ans. 6.)
During examination, claim terms are given their broadest reasonable
construction consistent with the specification. In general, words used in a
claim are accorded their ordinary and customary meaning. Honeywell Int 'l
Inc. v. Universal Avionics Sys. Corp., 488 F.3d 982, 992 (Fed. Cir. 2007). In
this case, Appellants cite to no evidence in the record or legal authority to
restrict the construction of "medical device" to those particular devices
regulated by the FDA. (See App. Br. 22.) We therefore decline to adopt
Appellant's narrow claim construction in this case. See In re Morris, 127
F.3d 1048, 1056 (Fed. Cir. 1997) ("Absent an express definition in their
specification, the fact that appellants can point to definitions or usages that
conform to their interpretation does not make the PTO's definition
unreasonable when the PTO can point to other sources that support its
interpretation.").
We are not persuaded that the Examiner committed harmful error in
finding obviousness based on the Examiner's construction of the term
"medical device." It is undisputed that Voelker shows "a coating zone 11"
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in which "sheet material 10 is power drawn through." (See Voelker col. 2,
11. 1-3.) It is undisputed that Voelker shows that the sheet material 10
"passes between metering rolls 12 and 13 ... including passage over rolls
15, 16, 17, and 18 before reentering the coating zone 11." (See id. at col. 2,
11. 3-6.) It is also undisputed that Voelker shows that after sheet material 10
is coated in coating zone 11, the "coated impermeable sheet" may move
forward "through power driven rolls 31 and 32" to be "collected on a
product reel 30." (See id. at col. 2, 11. 36-39, 49-63.)
Appellants do not dispute the Examiner's finding that the claimed
apparatus is not a medical device but a device that may be used to coat a
medical device. (See Ans. 6; see also App. Br. 21-23.) Based on Voelker's
device "for applying a layer of ... materials whose thickness is precisely
controlled to a ... sheet material" (Voelker col. 1, 11. 23-26) and Voelker's
"product removal zone" for collection of a coated sheet "on a product reel
30" (id. at col. 2, 11. 64, 72), "a person of ordinary skill can implement a
predictable variation" to arrive at the device recited in claim 10. (See Ans.
6-7 (finding, among others, that a skilled artisan may find claim 10 obvious
based on teaching of "roll (item 30)" and "the rod (which is ... not
labeled")); see also KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).)
We are not persuaded that harmful error has been shown in the Examiner's
fact findings here.
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Claim 813
Claim 8 depends from claim 1 and additionally recites a particular
"uniform thickness of [a] coating patch" which "is about half of the height of
the metering gap." (App. Br. 30.)
Appellants do not dispute the Examiner's finding that the TMI
reference discloses a "Bird applicator" that "produces a wet film thickness
equal to half of the gap size." (See App. Br. 26; see also NFR 6 (citing TMI
at 1 ).) Appellants, however, argue that the rejection of claim 8 should be
reversed because the cited art TMI brochure shows a "gap applicator"
instead of a "web" as recited. (App. Br. 26.) Appellants argue that "[t]here
is no teaching or suggestion in Voelker or the TMI brochure that the
impermeable sheet 10 of Voelker could be modified so that the thickness of
the foam forming chemicals would be less than the height of the gap." (Id;
Reply Br. 9.)
It is well-established that a determination of obviousness based on
teachings from multiple references does not require an actual, physical
substitution of elements. In re Mouttet, 686 F.3d 1322, 1332 (Fed. Cir.
2012); see In re Keller, 642 F.2d 413, 425 (CCPA 1981) ("The test for
obviousness is not whether the features of a secondary reference may be
bodily incorporated into the structure of the primary reference .... ").
Moreover, Appellants do not disagree with the Examiner's rationale that a
skilled artisan "would be motivated to set the dimensions of the gap coating
device of Voelker to the dimensions of TMI because TMI shows that those
are desirable settings for gap coating applications in general[.]" (See App.
Br. 25-26; NFR 6); see also KSR, 550 U.S. at 416-17 (holding that a
13 Claims 7 and 9 stand or fall with claim 8. (App. Br. 25.)
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combination of familiar elements according to known methods yielding no
more than predictable results that is likely to render a claim obvious).) No
harmful error has been shown in this aspect of the obviousness findings.
Claims 4 and 11
Appellants argue that the rejection of claim 4 should be reversed
because the cited art Allenberg "does nothing to address the failure of
Voelker to teach or suggest each and every element of independent claim 1."
(App. Br. 25.) Appellants also argue that the rejection of claim 11 should be
reversed because the cited art "Richard does nothing to address the failure of
Voelker." (Id. at 27.)
For the reasons provided with regard to the rejection of claim 1 based
on Voelker, we affirm the rejections of claims 4 and 11.
C. Order
It is ORDERED that the rejections of claims 1-12 are affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l.136(a).
AFFIRMED
17