Ex Parte Overstreet et al

Patent Trial and Appeal Board

Oct 31, 2017

13676310 (P.T.A.B. Oct. 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.
13/676,310 11/14/2012 Edward H. Overstreet 07-00524-05 5153
67876 7590
Advanced Bionics, LLC
c/o Fabian Vancott
215 South State Street
Suite 1200
Salt Lake City, UT 84111
EXAMINER
CARPENTER, WILLIAM R
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
11/02/2017 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):
patents @ fabianvancott.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte EDWARD H. OVERSTREET, JIAN XIE, MICHAEL S.
COLVIN, and MICHAEL A. FALTYS1
(Applicant: ADVANCED BIONICS, LLC)
Appeal 2016-008235
Application 13/676,310
Technology Center 3700
Before RICHARD J. SMITH, TAWEN CHANG, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a kit for
delivering therapeutic treatment to biological tissue. We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm.
1 According to Appellants, the real party in interest is Advanced Bionics,
LLC. (Appeal Br. 2.)
Appeal 2016-008235
Application 13/676,310
STATEMENT OF THE CASE
Claims on Appeal
Claims 1,2, and 13—19 are on appeal.2 (Claims Appendix, Appeal Br.
20-22.) Claims 16 and 1 are illustrative and read as follows:
16. A kit for delivering therapeutic treatment to biological tissue
comprising:
a surgically implantable lead comprising at least one preformed
cavity; and
a plurality of modular capsules configured to be retained in the at least
one preformed cavity comprising:
at least one dummy capsule;
a first capsule comprising a first therapeutic agent, the first
capsule configured to elute into biological tissue at a first concentration; and
a second capsule comprising a second therapeutic agent, the
second capsule configured to elute into biological tissue at a second
concentration.
{Id. at 21.)
1. The kit of claim 16, further comprising a third modular capsule
comprising:
a third therapeutic agent with a first solubility in biological fluids in
an implanted environment;
a fourth therapeutic agent with a second lower solubility in the
biological fluids;
in which dissolution of the third therapeutic agent increases a rate of
dissolution of the fourth therapeutic agent.
{Id. at 20.)
Examiner’s Rejections
1. Claims 16—19 stand rejected under pre-AIA 35 U.S.C. § 103(a)
2 Claims 10 and 22 are withdrawn from consideration as directed to a non-
elected invention. (Office Action dated Oct. 19, 2015 (“Final Act.”), at 2—
3.)
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as unpatentable over Doan,3 Gibson,4 Gunderson,5 and Jolly.6 (Final Act. 3—
6.)
2. Claims 1, 2, and 13—15 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Doan, Gibson, Gunderson, Jolly, and Ruane.7 (Id. at 6—
8.)
DISCUSSION
We adopt as our own the Examiner’s findings, analysis, and
conclusions as set forth in the Final Action (Final Act. 2—8) and Answer
(Ans. 2—18), including the Examiner’s findings regarding the scope and
content of, and reasons to modify or combine, the prior art. We discern no
error in the rejections of the claims as obvious.
Issue
Whether a preponderance of evidence of record supports the
Examiner’s rejections under 35 U.S.C. § 103(a).
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “[Wjhen a patent
‘simply arranges old elements with each performing the same function it had
been known to perform’ and yields no more than one would expect from
3 Doan et al., US 6,198,973 Bl, issued March 6, 2001 (“Doan”).
4 Gibson, US 2009/0076581 Al, pub. March 19, 2009 (“Gibson”).
5 Gunderson et al., US 2007/0123941 Al, pub. May 31, 2007
(“Gunderson”).
6 Jolly, US 2007/0088335 Al, pub. April 19, 2007 (“Jolly”).
7 Ruane et al., US 2007/0196423 Al, pub. Aug. 23, 2007 (“Ruane”).
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such an arrangement, the combination is obvious.” Id. at 417 (quoting
Sakraida v. Ag Pro. Inc., 425 U.S. 273, 282 (1976)).
Analysis
Rejection No. 1
Appellants separately argue claims 16, 17, and 18.
Claim 16
The Examiner finds that Doan discloses a kit for delivering
therapeutic treatment to biological tissue, including a surgically implantable
lead (30) comprising at least one preformed cavity (the interior of 54 or 36),
and at least one modular capsule (38) configured to be retained in the at least
one preformed cavity. (Final Act. 4; citing Doan Fig. 4.) Figures 3 and 4 of
Doan are illustrated below:
FIG-3
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FIG. 3 above is an exploded view of a tip electrode assembly and FIG.
4 above is a cross-sectional view of the tip electrode assembly. (Doan col. 3,
11. 14—17.)
The Examiner further finds that Doan discloses “a ‘first’ capsule (38)
comprising a first therapeutic agent and configured to elute into biological
tissue at a first concentration.” (Final Act. 4, citing Doan col. 3,1. 64—col. 4,
1. 13.)
The Examiner finds that “Gibson discloses a surgically implantable
lead (200) having at least one preformed cavity (224) configured to house at
least one modular capsule (300).” (Final Act. 4.) Figures 2A and 2B of
Gibson are illustrated below:
FIG. 2A above is a side view of an electrode assembly and FIG. 2B is
a cross-sectional view of the electrode assembly illustrated in FIG. 2A.
(Gibson H 11 and 12.)
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The Examiner further finds that Gibson’s system may be provided
with a plurality of drug release capsules comprising different drug
configurations, that the capsules can include at least one dummy capsule to
serve as a spacer or seal, and that the capsules may comprise a “second”
capsule comprising a “second” therapeutic agent configured to elute at a
“second” configuration. (Final Act. 4—5, citing Gibson || 22, 23, 60, and
61.)
Based on these findings, the Examiner concludes that:
It would have been obvious for a person having ordinary
skill in the art at the time the invention was made to provide the
kit of Doan with a plurality of capsules, as disclosed by Gibson,
including at least one dummy capsule and at least one “second”
therapeutic capsule, in order to configure the device of Doan to
accommodate a plurality of different therapeutics in a plurality
of different configurations.
(Final Act. 5.)8
Appellants argue that the Examiner has disregarded the plain meaning
of the term “kit,” and that “a ‘kit’ is defined as ‘a packaged collection of
related material.’” (Appeal Br. 10.)9 Moreover, according to Appellants,
“claim 16 recites specific related items assembled into a packaged collection
or ‘kit’” {id.), and that “[t]his specific combination of elements in the form
of a kit has not been demonstrated as taught or even suggested in the prior
art” {id. at 12).
8 The Examiner cites Gunderson and/or Jolly to establish that the pacing lead
of Doan and the cochlear lead of Gibson are relevant and analogous art, and
part of a single genus. (Final Act. 5.) Appellants do not dispute this finding.
9 Appellants cite to http://www.merriam-webster.com/dictionary/kit.
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Appellants also point to Figure 26 of the Specification to argue that
the kit 2600 is a box that includes the claimed items. (Appeal Br. 10.)
Figure 26 of the Specification is illustrated below:
Fig, 28
Fig. 26 above is an example of a kit that includes modular capsules.
(Spec. 130.)
We understand Appellants’ argument to be that the horizontal and
vertical lines on the perimeter of Fig. 26 illustrate a box. (Appeal Br. 10;
Reply Br. 5.)
We are not persuaded. A “kit” is an article of manufacture. In re
Venezia, 530 F.2d 956, 960 (CCPA 1976). Moreover, the term “kit” is not
defined in the Specification, and we find that the broadest reasonable
interpretation of the term “kit” is “a set of articles or equipment needed for a
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specific purpose.”10 This definition is consistent with that set forth by the
Examiner; namely, “a collection of articles usually for personal use,” “a set
of tools or implements,” or a “set of parts to be assembled or worked up.”
(Ans. 3^4 (emphasis omitted).)* 11 Thus, although Appellants’ proffered
definition refers to a kit as “packaged” (e.g., in a box), neither the
construction we adopt nor that of the Examiner requires a “kit” to be
packaged or in a box. 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.”).
Accordingly, although the articles or equipment of a kit may be in a
container or package, the construction or definition of “kit” as applicable to
claim 16 does not require that the articles or equipment be boxed or
packaged together, as argued by Appellants, and claim 16 does not recite
that the kit is boxed or packaged. Furthermore, we find that Fig. 26 merely
shows an example of “a set of articles or equipment needed for a specific
purpose” rather than showing that the term “kit” should be defined so as to
include a “box.” See Renishaw PLC v. Marposs Societa ’per Azioni, 158
F.3d 1243, 1249 (Fed. Cir. 1998) (definitions should be set forth in the
specification with reasonable clarity, deliberateness, and precision).
10http://www.oxfordreference.com/search?q=kit&searchBtn=Search&isQuic
kSearch=true, last visited October 13, 2017.
11 Fike Appellants, the Examiner also cites to Merriam-Webster’s Online
Dictionary — https://www.merriam-webster.com/dictionary/kit, last visited
Oct. 13,2017.
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Based on the foregoing construction of the term “kit” as used in claim
16, we agree with the Examiner that both Doan and Gibson teach or suggest
a kit. (Ans. 9—10.) The Examiner points to the “various requisite articles” in
Figure 3 of Doan, as well as Doan’s provision of “a steroid eluting pacing tip
electrode assembly . . . with fewer parts . . . and a simplified assembly
process.” (Doan col. 2,11. 58—61; see also description of component articles
at col. 3,11. 32—57.) The Examiner also finds that “Gibson discloses
providing a surgical lead together with a plurality of capsules for use in
combination with said lead [] thereby providing clear evidence of a ‘kit.’”
(Ans. 9, citing Gibson | 61.)12
Claim 17
Claim 17 recites “[t]he kit of claim 16, further comprising an insertion
tool to insert a modular capsule into the preformed cavity.” (Appeal Br. 21.)
The Examiner cites to Doan as disclosing “an insertion tool (32) to insert the
module capsule into the preformed cavity.” (Final Act. 5, citing Doan
Figures 3 and 4.) Appellants question how the housing (32) can be a tool to
insert the plug (capsule) into itself, and further argue that there is “no tool
taught or suggested in the cited references that is packaged in a kit with the
12 We acknowledge, but are unpersuaded by, Appellants’ argument
regarding “hindsight.” (Appeal Br. 12; Reply Br. 9.) Appellants point to no
evidence that any of the Examiner’s findings were beyond the level of
ordinary skill at the time of the invention or could have been taken only
from Appellants’ Specification. See In re McLaughlin, 443 F.2d 1392, 1395
(CCPA 1971).
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other recited items and that is used to insert a capsule . . . into [a preformed
cavity] in a lead.” (Appeal Br. 14—15.) Appellants also argue that it is
improper for the implantable electrode (30) of Doan to be both the
“surgically implantable lead” of claim 16 and the “insertion tool to insert a
modular capsule into” the cavity of the lead, as recited in claim 17. (Reply
Br. 11-13.)
We find that the Examiner has the better position. As the Examiner
explains, the “preformed cavity” of Doan is the interior of 54 (see FIG. 4
above), and the tool (32) does not “insert the plug into itself,” but “serves to
‘insert the plug’ into the space/cavity formed within the lead/sheath (54).”
(Ans. 10—11.) Furthermore, we do not find that the Examiner is improperly
using “a single structure/element in the prior art to disclose two separate
claimed elements” (Reply Br. 12) because the implantable lead of Doan
includes element 54 and the tool is element 32. (Ans. 10—11.) The
Examiner specifically points to Figures 3 and 4 of Doan to show how the
tool (32) is used to insert the modular capsule (38) into the preformed cavity
of the lead (54). (Id. at 11.) Moreover, there is no requirement in the claim
that the tool (32) be “packaged” in the kit separately from the other items.
See In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (rejecting arguments “not
based on limitations appearing in the claims”).
Claim 18
Claim 18 recites “[t]he kit of claim 17, in which the modular capsule
is preloaded into the insertion tool.” (Appeal Br. 21.) The Examiner finds
that “there exists a point in time where the module capsule MUST be loaded
into the insertion tool prior to its insertion into the preformed cavity.” (Final
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Act. 5.) Moreover, according to the Examiner, “the phrase ‘preloaded’ fails
to define or distinguish over the modified system of Doan just prior to the
insertion of the insertion tool (32) into the pre-formed cavity (54).” {Id. at
5-6.)
Appellants contest these findings by arguing that the Examiner has not
demonstrated any insertion tool in the prior art, and that the claim does not
recite that “at just any point in time the capsule is loaded into the insertion
tool.” (Appeal Br. 16.) Rather, according to Appellants, the claims require
that the modular capsule be preloaded into the insertion tool as presented in
a “kit.” {Id.) That is, according to Appellants, “claim 18 recites that, when
vackased as a ‘kit, ’ the modular capsule is already loaded in an insertion
tool designed to insert the capsule into the [preformed] cavity of the
implantable lead.” (Reply Br. 13.)
We are not persuaded. Doan’s teaching of an insertion tool is
addressed above. Furthermore, we agree with the Examiner that Appellants’
arguments “appear to be directed toward a temporal relationship in the
method of use of the article whereas the instant claims are directed toward
the article itself. . . . [I]n the context of an article of manufacture, it doesn’t
matter when the capsule(s) are loaded into the insertion tool. . . .” (Ans.
13.) Moreover, Appellants’ argument regarding what claim 18 recites is not
based on limitations appearing in claim 18. See Self, 671 F.2d at 1348.
Accordingly, for the reasons of record and as set forth above, we
affirm the rejection of claims 16—18. Claim 19 was not argued separately
and falls with claim 16.
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Rejection No. 2
We address claims 1 and 13, both of which are separately argued by
Appellants. Claim 13 is representative of claims 13 and 15, which
Appellants argue as a group.
Claim 1
The Examiner finds that Gibson discloses capsules that can be
provided as different embodiments, including capsules comprising multiple
layers or subparts. (Final Act. 6, citing Gibson || 22 and 54.) The
Examiner further finds that Gibson discloses capsule implementations
configured for “releasing the same or different drug at the same or different
rate, or having different concentrations of a drug across one or more portions
of the drug release capsule” (Gibson | 54), that is, a capsule comprising “a
‘third’ therapeutic agent having a higher solubility [than] a provided ‘fourth’
therapeutic agent.” (Final Act. 6.) Thus, according to the Examiner, Gibson
renders obvious a composition comprising “multiple layers.” {Id. at 6—7.)
The Examiner further finds that:
Ruane discloses a method of providing a multiple layer drug
release coating to a medical device (150). Ruane discloses that
the device should be provided with a permeable membrane (114)
wherein a layer of a first therapeutic (130) is provided interposed
between the permeable membrane and a second therapeutic (132)
such that dissolution of the first therapeutic agent increases the
rate of dissolution of the second therapeutic by increasing the
availability of the second therapeutic as the first therapeutic is
released.
(Final Act. 7, citing Ruane 1 68.) Figure 2B of Ruane, illustrating the
Examiner’s findings, is shown below:
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FIGURE 2B
130 114 140
160
Figure 2B immediately above illustrates a cross-sectional view of a coating
configuration. (Ruane ]f 18.)
Based on these findings, the Examiner concludes that:
It would have been obvious for a person having ordinary skill in
the art at the time the invention was made to provide multiple
layers on a “third” modular capsule of the device of Doan, as
disclosed by Gibson, wherein the layers are provided to effect
sequential delivery of the therapeutics, as disclosed by Ruane.
Ruane merely illustrates one implementation wherein a multi­
layered drug release product can be configured to elute two drugs
at different rates.
(Final Act. 7.)
Appellants reassert their arguments regarding claim 16, and further
argue that Gibson does not suggest the limitations of dependent claim 1.
(Appeal Br. 16—17.) In their Reply Brief, Appellants state that “[t]he
Answer now, for the first time, which is improperly belated, proposes a new
modification of Doan using Ruane.” (Reply Br. 15.) Appellants proceed to
argue Ruane in connection with the rejection of claim 13 (not claim 1),
particularly stating that Ruane does not restrict “the exposure of a modular
capsule or therapeutic agent to a single surface thereof.” {Id. at 15—16.)
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We are not persuaded. The rejection of claim 1 is based on the
combined teachings of Doan, Gibson, and Ruane, as set forth in the Final
Action (Final Act. 6—8). Furthermore, the Examiner relies on the teachings
of Ruane (not Gibson) for the dissolution of the third and fourth therapeutic
agents as recited in claim 1, and that reliance by the Examiner was not raised
for the first time in the Answer. Appellants’ failure to address Ruane in the
Appeal Brief constitutes a waiver of any arguments regarding Ruane that
could have been raised in response to the Final Office Action. See 37 C.F.R.
§ 41.37(c)(l)(iv); MPEP § 1205.02. Moreover, the arguments that
Appellants ultimately advance in connection with Ruane relate to the “single
surface exposed” limitation recited in claim 13 (discussed below), not the
particular limitations recited in claim 1. (See Reply Br. 15—16.)
Claim 13
Claim 13 recites “[t]he kit of claim 1, wherein the modular capsule is
placed in a cavity in an implant such that the modular capsule has a single
surface exposed to the biological fluids.” (Appeal Br. 20.) The Examiner
points to Figure 4 of Doan and finds that “Doan discloses that the modular
capsule is placed in the cavity of the implant such that the modular capsule
has a single exposed surface to the biological fluid.” (Final Act. 7.) The
Examiner also points to Ruane Figure 2B, with the teachings of Ruane
included in the rejection of claim 13 (dependent on claim 1), and finds that
Ruane “include[s] a frame (160) such that exposure to biological fluids must
occur through permeable membrane (114) in order to expose the drug
core/capsule (130) to biological fluids.” (Ans. 16.)
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Appellants argue that “[t]here is no teaching or suggestion in Doan
that biological fluids do not enter the housing (32) and surround the plug
(38),” and that, in contrast to Doan, “[Appellants’] lead is made of silicone
which can surround and seal to the modular capsule such that a side of the
capsule not immediate adjacent the opening of the receiving cavity is
‘covered’ and not exposed to biological fluids.” (Appeal Br. 18, citing Spec.
33 and 97.) Appellants argue that “Ruane makes clear that the different
layers of therapeutic agents may be eluting at the same time.” (Reply Br. 16,
citing Ruane 1 68.) Thus, according to Appellants, neither Doan nor Ruane
restrict “the exposure of a modular capsule or therapeutic agent to a single
surface thereof.” (Id.)
We find that the Examiner has the better position. As the Examiner
explains, “the frame (160) [of Ruane] ensures that the capsule has only a
single ‘exposed’ side (particularly when provided in the context of Doan
[]).” (Ans. 16.) As to Doan, the Examiner explains that the sheath (54) in
Doan creates an “enclosure for the steroid plug” and is also preferably made
of silicone. (Ans. 16—17, citing Doan col. 3,11. 55—57 and col. 4,11. 34—38.)
The Examiner also points to Figure 4 of Doan and explains that “the distal
opening [(64)] provides the ONLY path by which the capsule is ‘exposed to
the implanted environment,’ . . . therefore ONLY the distal facing surface of
the capsule is ‘exposed’ with all other sides being covered by the
combination of the housing/tool (32) and the sheath (54).” (Ans. 17.)
Accordingly, for the reasons of record and as set forth above, we
affirm the rejection of claims 1 and 13. Claims 2, 14, and 15 were not
argued separately and fall with claim 1.
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Conclusions of Law
Rejection No. 1: A preponderance of evidence of record supports the
Examiner’s rejection of claims 16—18 under 35 U.S.C. § 103(a). Claim 19
falls with claim 16 because it was not argued separately.
Rejection No. 2: A preponderance of evidence of record supports the
Examiner’s rejection of claims 1 and 13 under 35 U.S.C. § 103(a). Claims
2, 14, and 15 were not argued separately and fall with claim 1.
SUMMARY
We affirm the rejections of all claims on appeal.
TIME PERIOD FOR RESPONSE
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
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