Ex Parte Berglund

Patent Trial and Appeal Board

Feb 15, 2013

11276023 (P.T.A.B. Feb. 15, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JOSEPH BERGLUND
__________

Appeal 2011-004225
Application 11/276,023
Technology Center 3700
__________

Before TONI R. SCHEINER, STEPHEN WALSH, and
ERICA A. FRANKLIN, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) from the rejection of
claims directed to a system for treating a vascular condition. The Patent
Examiner rejected the claims for obviousness. We have jurisdiction under
35 U.S.C. § 6(b). We affirm.
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STATEMENT OF THE CASE
Claims 1-9 and 18-28 are on appeal. Claim 1 illustrates the subject
matter on appeal and reads as follows:
1. A system for treating a vascular condition, the system comprising:
a catheter;
an inflatable member operably attached to the catheter; and
a plurality of detachable microdarts connected to at least a portion of
the inflatable member, wherein the plurality of microdarts fold into the
inflatable member in a delivery configuration, wherein the plurality of
microdarts are covered by the inflatable member during delivery and
exposed during inflation of the inflatable member in an insertion
configuration and wherein the detachable microdarts are configured to
detach from the inflatable member upon insertion into a target region.

The Examiner rejected the claims as follows:
A. claims 1, 2, 4-8, 21, 22, and 24-27 under 35 U.S.C. § 103(a) as
unpatentable over Naimark
1
and Park;
2

B. claims 9, 18-20, and 28 under 35 U.S.C. § 103(a) as unpatentable over
Naimark, Park, Reed,
3
and Donovan;
4
and
C. claims 3 and 23 under 35 U.S.C. § 103(a) as unpatentable over
Naimark, Park, and Tobinaga.
5

OBVIOUSNESS
Appellant addresses rejection A with independent claims 1, 18, and 21
grouped together. (App. Br. 11.) To address rejections B and C, Appellant

1
Wendy Naimark et al., US 6,638,246 B1, issued Oct. 28, 2003.
2
Jung-Hwan Park et al., US 2002/0082543 A1, published June 27, 2002.
3
Michael L. Reed et al., US 6,197,013 B1, issued March 6, 2001.
4
Maura G. Donovan et al., US 2004/0220607 A1, published Nov. 4, 2004.
5
Yoshikazu Tobinaga et al., US 2005/0065463 A1, published March 24,
2005.
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relies on the rejection A arguments (id. at 13), and the same issues are
therefore dispositive for all three rejections. We select claim 1 as
representative. As claims 2-9 and 18-28 have not been argued separately,
they will stand or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

The Issues
The Examiner found that (i) Naimark disclosed all the elements of
claim 1 including detachable microneedles or microdarts (Ans. 3-4), but
(ii) if Naimark did not disclose detachable microneedles or microdarts, Park
did so (id. at 4-5). The Examiner then concluded:
It would have been obvious for one having ordinary skill in the
art at the time the invention was made to modify the device of
Naimark to utilize detachable microneedles, as disclosed by
Park, in order to allow for controlled release of the drug,
specific drug release patterns, and specific interactions with
body cells.

(Id. at 5.)
According to the Examiner, (iii) Naimark disclosed microdarts that
fold into an inflatable member as claimed (id. at 5-6), but (iv) if Naimark did
not disclose the claimed fold configuration,
it would have been obvious for one having ordinary skill in the
art at the time the invention was made to form the microdarts to
fold alongside the inner surface of the balloon of the
embodiment of [Naimark‘s] Fig. 4 such that they lay covered
by the outer surface of the balloon, as generally illustrated in
[Naimark‘s] Fig. 6, thereby only establishing the expected
results of providing a suitable means for ensuring the
microdarts are protected while in the delivery configuration

(id. at 6).
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Appellant disputes the Examiner‘s points (i) through (iv) and further
argues that Naimark teaches away from using Park‘s detachable
microneedles. Appellant also contends that (v) likening Naimark‘s needles
which are disposed on a plate to the claimed microdarts is flawed ―since the
microdarts are claimed as ‗connected to the inflatable member‘ and not to
any plate‖ (App. Br. 11); and (vi) ―the Examiner‘s suggested modification
would impermissibly destroy the functioning of [Naimark‘s] device‖ (id. at
12).

Findings of Fact
1. Naimark‘s patent is entitled ―Medical Device For Delivery Of A
Biologically Active Material To A Lumen.‖ (Naimark, Title)
(emphasis omitted.)
2. Naimark described the device as an ―apparatus for delivery of
biologically active materials comprises a catheter and [a] balloon
having micro-needles . . . . the biologically active material is
delivered through lumens in the micro-needles.‖ (Id., Abstract.)
3. Naimark‘s Figure 4B is reproduced here:
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Figure 4B ―depict[s] a cross-sectional view along the longitudinal axis
of another embodiment of a balloon catheter of the invention, wherein
solid micro-needles are disposed upon a plate which is disposed upon
a balloon surface or within the balloon wall and the micro-needles
project through a porous outer surface of the balloon.‖ (Id. at col. 3,
ll. 17-22.)

4. Naimark explained Figure 4B as follows:
FIG 4B shows another embodiment of an apparatus of
the present invention. A plurality of solid micro-needles 41 are
disposed upon a plate 403. The plate 403 is disposed between
an outer layer 47b and an inner layer 47a of an balloon wall 47
of a balloon 40B. The outer layer 47b has a plurality of pores
42. The micro-needles 41 are positioned such that they project
through the outer layer 47b and are disposed on an outer surface
of the balloon. The plate 403 and the outer layer 47b define a
compartment 45, which contains a biologically active material.
The biologically active material is placed into the compartment
45 using a first catheter lumen 49b. The balloon 40B of this
embodiment is inflated in a body lumen by inserting a liquid or
gas into an inflation compartment 46 using an inflation lumen
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49a of the catheter 49 having a guidewire 48. Upon inflation,
the micro-needles 41 contact a surface of the body lumen
piercing the surface and create micro nano-pores in the surface.
The biologically active material is expelled from the pores 42
and is delivered into the micro- or nano-pores created by the
micro-needles 41. After the biologically active material is
delivered, the balloon is deflated and removed from the body
lumen.

(Id. at col. 5, l. 65 – col. 6, l. 19.)
5. Naimark‘s Figures 6A-6C are reproduced here:

―FIG. 6B depicts a cross-sectional view of the same embodiment
which is cut along the line I-I in FIG. 6A. A portion of the FIG. 6B is
enlarged to FIG. 6B'. FIG. 6C shows the same portion as in FIG. 6B'
and the balloon is in its inflated state.‖ (Id. at col. 3, ll. 38-42.)
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6. Naimark explained Figures 6A – 6C as follows:
FIG. 6A is a cross-sectional view of a balloon 60 along
its longitudinal axis, and FIG. 6B is a cross-sectional view of
the balloon 60 along line I-I in FIG. 6A. A portion of FIG. 6B is
enlarged and referred to as FIG. 6B'. FIG. 6C shows the same
portion of the balloon as in FIG. 6B' and in its inflated state.
The balloon 60 has generally the same structure as that shown
in FIGS. 5A and 5B except that it has solid micro-needles 64
instead of micro-needles having lumens and does not have an
interior compartment. A plurality of micro-needles 64 are
disposed upon a plate 602 which is disposed on the outer
surface 67a of a balloon wall 67. The balloon 60 comprises an
inflation compartment 66. When the balloon 60 is in its
deflated state, the micro-needles 64 lay along the outer surface
67a of the balloon wall 60 and are covered by a sheath 62 as
shown in Fig. 6B‘. The sheath 62 has a plurality of ports or
openings 61.

(Id. at col. 6, l. 60 – col. 7, l. 8.)
7. Naimark stated: ―Bioabsorbable polymers are preferable in case the
micro-needles are broken and left in a body lumen or tissue.‖ (Id. at
col. 12, ll. 51-53.)
8. Park‘s patent application is entitled ―Microneedle Devices And
Production Thereof.‖ (Park, Title) (emphasis omitted.)
9. According to Park:
The devices disclosed herein are useful in transport of
material into or across biological barriers including the skin (or
parts thereof); the blood-brain barrier; mucosal tissue (e.g., oral,
nasal, ocular, vaginal, urethral, gastrointestinal, respiratory);
blood vessels; lymphatic vessels; or cell membranes (e.g., for
the introduction of material into the interior of a cell or cells).
The biological barriers can be in humans or other types of
animals, as well as in plants, insects, or other organisms,
including bacteria, yeast, fungi, and embryos. The microneedle
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devices can be applied to tissue internally with the aid of a
catheter or laparoscope.

(Id. at 3, [0034].)
10. Park disclosed:
In one variation of this embodiment, the micro-needles
may be purposefully sheared off from the substrate after
penetrating the biological barrier. . . . The portion of the
microneedles which remains in the skin or other biological
barrier then releases drug over time according to a profile
determined by the composition and geometry of the
microneedles, the concentration of the drug, and other factors.

(Id. at 10, [0124].)
11. Park disclosed:
Microneedle shape and content can be designed to
control the breakage of microneedles. For example, an
indentation can be introduced into microneedles either at the
time of fabrication or as a subsequent step. In this way,
microneedles preferentially break at the site of the indentation.

(Id. at 10, [0126].)

Principles of Law
[O]bviousness must be determined in light of all the facts, and
there is no rule that a single reference that teaches away will
mandate a finding of nonobviousness. Likewise, a given course
of action often has simultaneous advantages and disadvantages,
and this does not necessarily obviate motivation to combine. . .
. Where the prior art contains ―apparently conflicting‖
teachings (i.e., where some references teach the combination
and others teach away from it) each reference must be
considered ―for its power to suggest solutions to an artisan of
ordinary skill.... consider[ing] the degree to which one reference
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might accurately discredit another.‖ In re Young, 927 F.2d 588,
591 (Fed.Cir.1991).

Medichem, S.A. v. Rolabo, S.A., 437 F.3d 1157, 1165 (Fed. Cir. 2006).
In re Mouttet, 686 F.3d 1322, 1332 (Fed. Cir. 2012) (the Board‘s
determination that the difference in the circuitry—electrical versus optical—
does not affect the overall principle of operation of a programmable
arithmetic processor was supported by substantial evidence. See, e.g., In re
Umbarger, 407 F.2d 425, 430-31 (CCPA 1969) (finding [In re Ratti, 270
F.2d 810, 813 (CCPA 1959)] inapplicable where the modified apparatus will
operate ―on the same principles as before‖).

Analysis
On issue (i), we agree with Appellant that Naimark did not describe
detachable micro darts configured to detach from the inflatable member
upon insertion into a target region. (See App. Br. 11.) Contrary to the
Examiner‘s interpretation, ―configured to detach‖ is a structural limitation,
not the mere capability of being broken if sufficient force is brought to bear.
The rejection relying on that claim interpretation is reversed.
The Examiner‘s second basis for rejection (issue (ii)) is that Naimark
and Park rendered the claims obvious. On issue (ii), we agree with the
Examiner. As the Examiner found, Naimark was aware that microneedles
could break, and specifically taught using bioabsorbable materials to
accommodate that possibility, thus avoiding complications that might be
caused by non-resorbable needles. (FF 7.) Like Naimark, Park explicitly
taught that its invention was to be used in blood vessels, among other
tissues. (FF 9.) Improving Naimark‘s micro-needles by using Park‘s
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detachable configuration would allow for controlled release of drug, specific
release patterns, and specific interactions with body cells, as the Examiner
found. (Ans. 5.) ―[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’l Co. v. Teleflex Inc.,
550 U.S. 398, 417 (2007).
We also agree with the Examiner that Naimark did not teach away
from combining Park‘s teachings with its own. (Ans. 11.) Naimark
apparently did not see the advantages in microdarts or needles configured to
detach, and its teaching to avoid complications caused by breakage by using
resorbable material was not a suggestion to deliberately make the darts
detachable. However, Park disclosed the advantages of detachable
microneedles or darts, and effectively showed how the breakage that
Naimark may not have preferred could be turned to advantage if designed
into the device. A person of ordinary skill in the art would have appreciated
that aspect of Park, and seen how Park‘s teaching would have outweighed a
negative inference drawn from Naimark. See Medichem, 437 F.3d at 1165.
Appellant contends that likening Naimark‘s needles which are
disposed on a plate to the claimed microdarts is flawed ―since the microdarts
are claimed as ‗connected to the inflatable member‘ and not to any plate.‖
(App. Br. 11.) Naimark explained the connection of the needles to a plate on
the inner or outer surface of the balloon. (FF 4, 6.) The Examiner responds
that Naimark‘s needles are properly considered as ―connected to the
inflatable member,‖ even if connected through a plate, which itself expands
and contracts with the surface of the balloon. (Ans. 10.) Appellant does not
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direct attention to a limiting definition of ―connected‖ excluding connection
via a plate. Under this circumstance, we agree with the Examiner that
Naimark‘s needles are connected to an inflatable member.
Appellant contends that the Examiner's suggested modification would
impermissibly destroy the functioning of Naimark‘s device. (App. Br. 12-
13.) According to Appellant, detached ―micro-needles would prevent the
therapeutic agent from seeping into the pore‖ created by the micro-needle.
(Id. at 13.) This argument is unpersuasive because Naimark and Park
described the same function – deliver a therapeutic agent via microdart or
needle. (See Ans. 12.) See, In re Umbarger, 407 F.2d 425, 430-31 (CCPA
1969) (finding similar argument unpersuasive where the modified apparatus
will operate ―on the same principles as before‖).

SUMMARY
We affirm the rejection of claims 1, 2, 4-8, 21, 22, and 24-27 under
35 U.S.C. § 103(a) as unpatentable over Naimark and Park.
We affirm the rejection of claims 9, 18-20, and 28 under 35 U.S.C.
§ 103(a) as unpatentable over Naimark, Park, Reed, and Donovan.
We affirm the rejection of claims 3 and 23 under 35 U.S.C. § 103(a)
as unpatentable over Naimark, Park, and Tobinaga.
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

cdc