Ex Parte Cima et al

Patent Trial and Appeal Board

Aug 24, 2016

12333182 (P.T.A.B. Aug. 24, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/333, 182 12/11/2008
29052 7590 08/26/2016
SUTHERLAND ASBILL & BRENNAN LLP
999 PEACHTREE STREET, N.E.
Suite 2300
ATLANTA, GA 30309
FIRST NAMED INVENTOR
Michael J. Cima
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.
17648-0067 (MIT 12988) 5884
EXAMINER
CARPENTER, WILLIAM R
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
08/26/2016 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):
patent. docket@sutherland.com
pair_sutherland@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL J. CIMA and HEEJIN LEE
Appeal2014-001673
Application 12/333, 182
Technology Center 3700
Before LINDA E. HORNER, EDWARD A. BROWN, and JILL D. HILL,
Administrative Patent Judges.
HILL, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Michael J. Cima and Heejin Lee ("Appellants") appeal under 35
U.S.C. § 134(a) from the Examiner's decision to reject claims 1, 2, 6-10, 12,
14, 16, 17, 19, 21, 23, 25, 27-30, 33 and 50. 1 We heard oral argument on
August 11, 2016. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 Claims 3-5, 11, 13, 15, 18, 20, 22, 24, 26, 31, 32, and 34--49 are canceled.
Appeal Br., Claims App.
Appeal2014-001673
Application 12/333, 182
CLAIMED SUBJECT MATTER
Independent claims 1, 27, and 50 are pending. Claim 1, reproduced
below, illustrates the subject matter on appeal, with the key disputed
limitation italicized.
1. An implantable medical device for controlled drug
delivery comprising:
a drug reservoir portion comprising a drug; and
a retention frame portion attached to the drug reservoir
portion, the retention framing portion comprising an elastic
wire,
wherein the device is elastically deformable between a
relatively straightened shape suited for insertion through a
lumen into a body cavity of a patient and a coiled shape suited
to retain the device within the body cavity, the elastic wire
functioning as a spring to maintain the device in the coiled
shape in the absence of a compressive load.
REJECTIONS
I. Claims 1, 6, 9, 10, 12, 16, 19, 21, 25, and 50 stand rejected
under 35 U.S.C. § 103(a) as unpatentable over Matsuura (US 6,171,298 Bl;
iss. Jan. 9, 2001) and Li (US 2007/0255222 Al; pub. Nov. 1, 2007). Final
Act. 2.
II. Claim 2 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Matsuura, Li '222, and Gianchandani (US 2004/0149294
Al, pub. Aug. 5, 2004). Final Act. 7.
III. Claims 7 and 8 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Matsuura, Li '222, and Li (US 2004/0022824 Al, pub.
Feb. 5, 2004). Final Act. 8.
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Application 12/333, 182
IV. Claims 10, 14, 17, 27, 30 and 33 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Matsuura, Li '222, and Zentner (US
4,968,507, iss. Nov. 6, 1990). Final Act. 9.
V. Claim 23 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Matsuura, Li '222, and Lee (US 2007/0202151 Al, pub.
Aug. 30, 2007). Final Act. 12.
VI. Claim 28 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Matsuura, Li '222, Zentner, and Li '824. Final Act. 13.
VII. Claim 29 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Matsuura, Li '222, Zentner, and Gianchandani. Final Act.
14.
ANALYSIS
Rejection I - Claims 1, 6, 9, 10, 16, 19, 21, and 25
Appellants argue claims 1, 6, 9, l 0, 16, 19, 21, and 25 as a group. \Ve
select independent claim 1 as representative of the group. See 37 C.F.R.
§ 41.37(c)(l)(iv). Claims 6, 9, 10, 16, 19, 21, and 25 stand or fall with claim
1.
The Examiner finds that Matsuura discloses the limitations of claim 1,
including reference to employing a shape memory material to prevent the
device from returning to its original shape (Matsuura, 8:36-41 ("In one
embodiment, the device has shape memory so that the device does not return
to its original shape simply by dispensing its contents.")), but finds that
Matsuura does not explicitly disclose its wire 34 functioning as a spring
(supplying the recited spring force) to expand and maintain the device in the
coiled shape in absence of a compressive load. See Final Act. 3. The
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Application 12/333, 182
Examiner finds, however, that Li '222 discloses elastic and resilient
members 127 that comprise wires 129 of a shape memory material that use
spring force to expand and maintain the device in a coiled shape for device
retention. Id. at 4 (citing Li, Figure 3(b) and i-f 37). The Examiner concludes
that it would have been obvious to form Matsuura's wire 34 of the material
of Li's shape memory wire 129 to ensure that Matsuura's "device does not
return to its original shape simply by dispensing its contents." Id. at 3, 4.
Appellants first argue that the Examiner's combination of Matsuura
and Li '222 "would only be obtainable using improper reliance on hindsight
reconstruction." Appeal Br. 7. According to Appellants, one skilled in the
art, starting with the device of Matsuura, would not have looked to Li '222
because "Li's device (i) is not intended for the bladder, (ii) is not a drug
delivery device ... , and (iii) is not configured to be retained wholly within
any body cavity, since the end of the feeding tube necessarily extends
outside of the patient's body." Id. at 9.
The Examiner responds that Matsuura provides sufficient instructions
for one skilled in the art to produce an embodiment using a shape memory
material, as disclosed at column 8, lines 36-41, wherein the device employs
a shape memory material in its wire 34, allowing the device to retain its
curved shape. Ans. 1 7. According to the Examiner,
Given the EXPLICIT reference by Matsuura of the
advantageous second embodiment wherein the device exhibits
a "shape memory" such that [] the device retains a shape
which does not pass out the urethra ... [,] an ordinary artisan
would look to prior art medical fluid delivery devices which are
known in the art to exhibit shape memory to control the shape
between a straightened delivery configuration and a curved
retention configuration[]. In looking for such art, an ordinary
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Application 12/333, 182
artisan would be made aware of the Li reference which shares
the shape explicit reference towards "shape-memory materials"
to accomplish the same goal, i.e. ensure that the device maintains
a curved anchoring shape ....
Id. at 18.
The Examiner states that the proffered reason for combining Matsuura
and Li '222 comes from Matsuura itself, rather than hindsight
reconstruction. Ans. 19. We agree. In addition, regarding Appellants'
reasons (i)-(iii) above, we disagree with Appellants' contention that one
skilled in the art would not combine Matsuura and Li '222 unless Li '222
was directed to a drug delivery device intended to be wholly retained within
the bladder. See, e.g., In re Bigio, 381F.3d1320, 1325 (Fed. Cir. 2004)
(holding that a reference is analogous art and proper for use in an
obviousness rejection if the reference is reasonably pertinent to the problem
faced by the inventor).
Regarding Appellants' argument that Matsuura cannot be read as
teaching wire 34 effecting a shape change, but rather that Matsuura discloses
that its entire device effects a shape change (Appeal Br. 10 (citing Cima
Dec. i-f 9) ), we are not persuaded by this argument in light of the Examiner's
combination of Matsuura with Li '222, wherein the wire 129 of Li '222
would be employed in place of Matsuura's wire 34, rather than being
employed as Matsuura's entire device.
Regarding Appellants' arguments that Matsuura's wire 34 does not
function as a spring (Appeal Br. 10 (citing Cima Dec. i-f 4)) or cause the
device to take a coiled shape (id. at 11 (citing Cima Dec. i-f 6)), we are not
persuaded by these arguments, because they do not address the rejection as
set forth by the Examiner. The Examiner's rejection looks to Li '222, not
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Matsuura, for these teachings. Final Act. 4 (citing Li '222, Figure 3 (b) and i-f
37).
Regarding Appellants' argument that employing the shape memory
wire 129 of Li '222 in Matsuura would change Matsuura's principle of
operation (Appeal Br. 12 (defining the principle of operation as liquid filling
and expanding the device to cause "the tensile member to urge the device
into a shape and size by inhibiting axial extension of the device")), we
disagree with Appellants' stated principle of operation of Matsuura. The
principle of operation of Matsuura can be more accurately stated as inserting
a drug delivery device into a bladder and then expanding the device to retain
the device in the bladder at least during the period of drug infusion. See
Matsuura, Abstract. This principle of operation is more accurate at least
because it encompasses Matsuura' s alternate embodiment that employs a
shape memory material. See Matsuura 8:36-41. This principle of operation
would not be changed by employing a shape memory wire in Matsuura.
Claim 50
Regarding claim 50, which recites the elastic wire being aligned
substantially parallel with the elastomeric tube, Appellants argue that
Matsuura' s wire 34 is not parallel with its pressure member 16, and that
making these two elements parallel would change the principle of operation
of Matsuura. Appeal Br. 14. Appellants fail to explain why such alignment
would change the principle of operation, and we disagree with their
determination.
Even ifMatsuura's wire 34 does not run parallel to a surface of its
pressure member 16 when the device is straight before filling and curved
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when filled, which assertion is contrary to the depiction of Matsuura's
Figures 1 and 2, respectively, such a parallel configuration would not change
the principle of operation of Matsuura's device as defined above.
Claim 12
Claim 12 recites an elastomeric tube controlling drug release "at least
in part by osmosis and compris[ing] one or more apertures for dispensing the
drug at a controlled rate." The Examiner finds that Matsuura discloses an
embodiment employing osmosis for drug delivery (Final Act. 4 (citing
Matsuura 19:41--46)). Appellants argue:
A person of ordinary skill in the art would understand that
osmotic systems, such as the ALZET pump, are substantially
rigid and would be inconsistent with pressure member 16 being
elastic. (See Cima Declaration, i-f 15). Accordingly, if
Matsuura' s pressure member 16-which is the only elastomeric,
drug containing tube disclosed in Matsuura-must be
"substituted" to provide osmotically-driven infusion, there
\'l/ould be no elastomeric tube to control release of drttg in part
by osmosis. (See Cima Declaration, i-f 15).
Appeal Br. 15. Cima's Declaration, however, discusses only one type of
osmotic pump - the ALZET pump - in concluding that one skilled in the art
would not employ osmosis for Matsuura's drug release. Cima's Declaration,
therefore, falls short of establishing that one skilled in the art would not
understand that any other osmotic system is available to replace Matsuura's
pressure member 16. We therefore are not persuaded by this argument.
For the reasons set forth above, we sustain Rejection I.
Rejection III and VI- Claims 7, 8, and 28
Claims 7 and 8 depend from independent claim 1 and recite the elastic
wire having an uncompressed state "which is curled in the form of two or
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more loops," the ends of the elastic wire being "bounded within said one or
more loops." Claim 28 depends from independent claim 27 and contains
similar limitations. The Examiner finds this claim limitation disclosed in the
drug delivery device 100 of Li '824, which is "formed by two loops (102)
wherein the first and second ends ( 106) of the device are bounded within the
one or more loops." Final Act. 8 and 13.
Appellants argue that the device of Li '824 "is not designed to be a
free-floating, unloaded implant" and is silent regarding a retention frame or
shape change functionality, such that one skilled in the art "would not have
had any reason to combine Matsuura and Li ['824] ... without using
Applicants' specification as a blueprint." Appeal Br. 17-18.
The Examiner responds that it would have been obvious to one skilled
in the art to alter the shape of Matsuura' s device "to comprise two loops, as
disclosed by Li ['824] in order to form a better retaining shape." Ans. 31.
The Examiner continues that "[ c ]hanges in shape have been held to be
obvious design choices for an ordinary artisan, particularly when the prior
art (Matsuura) expressly contemplates that other designs are possible and
desired." Id.; see In re Kuhle, 526 F.2d 553, 555 (CCPA 1975).
Given that Appellants' Specification discloses a variety of suitable
retention frame shape embodiments (see Figures 6 and 7), and Matsuura also
discloses that various retention shapes can be employed (Matsuura, 8:8-12
("it will be understood that other shapes, including sinusoidal, helical,
supercoiled, and random folded shapes are also within the scope of the
present invention")), the Examiner has the better argument regarding
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obviousness of the proposed shape choice. We therefore sustain rejections
III and VI.
Rejection IV-Claims 10, 14, 17, 27, 30 and 332
Appellants' argument regarding claim 12, set forth above, applies to
claims 10, 14, 17, 27, 30, and 33, which are argued as a group. As set forth
above, we are not persuaded by this argument.
Appellants' also argue that, if Matsuura's device was water permeable
upon combination with Zentner's teachings, it would be inoperable and
unsuitable for its intended purpose, because it relies on a water-impermeable
pressure member 16 to contain and release its liquid drug solution through a
pressure responsive valve. Appeal Br. 15. The Examiner's combination of
Matsuura, Li, and Zentner, however, proposes to replace Matsuura's
pressure delivery with osmosis, as proposed by Matsuura itself. Matsuura,
19:41--43 ("osmotically driven infusion means is substituted for the pressure
member 16"). Appellants' argument does not persuade us that one skilled
in the art would be unable to employ osmosis to cause infusion in
Matsuura's drug infusion device, particularly given that Matsuura is
modified in the rejection to utilize a shape memory material for deployment,
rather than pressurizing its pressure member 16. We are apprised of no
intended purpose of Maatsura for which the modified device would be
unsuitable. We therefore sustain Rejection IV.
2 Appellants do not argue for the patentability of claim 17. Appeal Br. 14;
Reply Br. 10.
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Rejections II and VII- Claims 2 and 29
Claims 2 and 29 recite "the elastic wire ha[ ving] a spring constant
between 3 Nim and 60 Nim." The Examiner finds this disclosure in
Gianchandani's wires 16. Final Act. 7, 15 (citing Gianchandani i-f 99).
Appellants argue that Gianchandani' s spring test determines the
spring constant of the overall stent, rather than the individual wires 16, and
that "[t]he spring constant of an entire stent cannot properly be compared
with the spring constant of the claimed retention wire." Appeal Br. 17
(citing Cima Declaration i-f 19). We agree with Appellants that the Examiner
erred in finding that Gianchandani discloses a wire having the claimed
spring constant. Further, the Examiner failed to provide a reason why one
skilled in the art would have found it obvious to utilize the spring constant of
an overall stent in the claimed retention frame elastic wire. We therefore do
not sustain rejections II and VII.
Rejection V- Claim 23
Claim 23 recites the drug reservoir portion comprising "a first end
attached to a first location on an intermediate region of the retention frame
portion," and "a second end attached to a second location on an intermediate
region of the retention frame portion." The Examiner finds this claim
limitation disclosed in Lee, which illustrates a drug reservoir 12 connected
to retention projections 16. Final Act. 13; Lee Fig. lB and i-f 47.
Appellants argue that the ends of Lee's drug reservoir 12 are not
attached to an intermediate region of the alleged retention frame 16. Appeal
Br. 17.
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The Examiner responds that Appellants' argument is based on an
"impermissibly narrow construction" of the term "end," and that "by virtue
of its three dimensional structure, the device of Lee has many ends." Ans.
29. According to the Examiner, because the claims do not limit the term
"end," the portions of Lee's tube 12 to which its wires 16 attach "may be
viewed as ends as they constitute extremes along the minor axis of the
device." Id. The Examiner has the better argument, as Appellants do not
provide us with a definition of the term "end" that refutes the Examiner's
argument.
Appellants then argue that modifying Matsuura in view of Lee "would
render the tensile member [34] ineffective for its stated purpose" of
connecting the proximal and distal ends of the device to urge the device into
a curved shape upon inflation. Reply Br. 15. This argument is not
persuasive, because it does not address the combination of references
proposed by the Examiner, which includes utilizing shape memory material
for the tensile member 34 of Matsuura. We therefore sustain Rejection V.
DECISION
We AFFIRM the Examiner's rejection of claims 1, 6, 9, 10, 12, 16,
19, 21, 25, and 50 under 35 U.S.C. § 103(a) as unpatentable over Matsuura
and Li '222.
We REVERSE the Examiner's rejection of claim 2 under 35 U.S.C.
§ 103(a) as unpatentable over Matsuura, Li, and Gianchandani.
We AFFIRM the Examiner's rejection of claims 7 and 8 under 35
U.S.C. § 103(a) as unpatentable over Matsuura, Li '222, and Li '824.
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We AFFIRM the Examiner's rejection of claims 10, 14, 17, 27, 30
and 33 under 35 U.S.C. § 103(a) as unpatentable over Matsuura, Li '222,
and Zentner.
We AFFIRM the Examiner's rejection of claim 23 under 35 U.S.C.
§ 103(a) as unpatentable over Matsuura, Li '222, and Lee.
We AFFIRM the Examiner's rejection of claim 28 under 35 U.S.C.
§ 103(a) as unpatentable over Matsuura, Li '222, Zentner, and Li '824.
We REVERSE the Examiner's rejection of claim 29 under 35 U.S.C.
§ 103(a) as unpatentable over Matsuura, Li '222, Zentner, and
Gianchandani.
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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