Ex Parte Lee et al

Patent Trials and Appeals Board

Jun 19, 2019

12825215 - (D) (P.T.A.B. Jun. 19, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/825,215 06/28/2010
29052 7590 06/21/2019
Eversheds Sutherland (US) LLP
999 PEACHTREE STREET, N.E.
Suite 2300
ATLANTA, GA 30309
FIRST NAMED INVENTOR
Heejin Lee
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.
29449-0017 1288
EXAMINER
OSINSKI, BRADLEY JAMES
ART UNIT PAPER NUMBER
3783
NOTIFICATION DATE DELIVERY MODE
06/21/2019 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):
patentdocket@eversheds-sutherland.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HEEJIN LEE and CHERYL LARRIVEE-ELKINS
Appeal2019-000706
Application 12/825 ,215
Technology Center 3700
Before JAMES P. CALVE, WILLIAM A. CAPP, and LEE L. STEPINA,
Administrative Patent Judges.
CAPP, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants 1 seek our review under 35 U.S.C. § 134(a) of the final
rejection of claims 1-11, 26-36, 38, 39, and 41-54. We have jurisdiction
under 35 U.S.C. § 6(b). 2
We AFFIRM.
1 TARIS Biomedical LLC is the real party in interest. Appeal Br. 2.
2 This case came before the Board for regularly scheduled oral hearing on
June 6, 2019.
Appeal2019-000706
Application 12/825,215
THE INVENTION
Appellants' invention relates to drug delivery devices. Spec. 1.
Claim 1, reproduced below, is illustrative of the subject matter on appeal.
1. An intravesical drug delivery device comprising:
a device body comprising a drug reservoir lumen and a
retention frame lumen;
a plurality of solid, compressed or molded, drug tablets
positioned in the drug reservoir lumen; and
a retention frame positioned in the retention frame lumen,
wherein the plurality of tablets in the drug reservoir lumen
comprise a single drug.
THE REJECTIONS
The Examiner relies upon the following as evidence in support of the
rejections:
Lieb
Urquhart
Matsuura
Lennox
Cima
us 3,089,815
us 4,578,075
US 6,171,298 Bl
US 6,537,193 Bl
US 2009/0149833 Al
May 14, 1963
Mar. 25, 1986
Jan.9,2001
Mar. 25, 2003
June 11, 2009
The following rejections are before us for review:
1. Claims 1--4, 9--11, 26, 27, 30, 32-36, 38, 39, 41, and 44--49 are
rejected under 35 U.S.C. § I03(a) as being unpatentable over Cima and
Urquhart.
2. Claim 5 is rejected under 35 U.S.C. § I03(a) as being unpatentable
over Cima, Urquhart, and Lieb.
3. Claims 6-8, 28, 29, 42, 43 and 50-54 are rejected under 35 U.S.C.
§ I03(a) as being unpatentable over Cima, Urquhart, and Matsuura.
4. Claim 31 is rejected under 35 U.S.C. § I03(a) as being
unpatentable over Cima, Urquhart, and Lennox.
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OPINION
Unpatentability of
Claims 1-4, 9--11, 26, 27, 30, 32-36, 38, 39, 41, and 44-49
over Cima and Urquhart
Claims 1-4, 9--11, 26, 27, 30, 32, and 44-49
Appellants argue claims 1--4, 9-11, 26, 27, 30, 32, and 44--49 as a
group. Appeal Br. 6-14. We select claim 1 as representative. See 37 C.F.R.
§ 4I.37(c)(l)(iv).
The Examiner finds that Cima discloses the invention substantially as
claimed except for drugs in the reservoir being formed as "tablets," for
which the Examiner relies on Urquhart. Final Action 2-3. The Examiner
concludes that it would have been obvious to a person of ordinary skill in the
art at the time of the invention to modify the device of Cima to carry tablets
as claimed. Id. According to the Examiner, a person of ordinary skill in the
art would have done this to control drug delivery from the device. Id.
Appellants argue that Urquhart is non-analogous art such that the
Examiner relied on improper hindsight reasoning in combining the teachings
of Cima and Urquhart in the rejection. Appeal Br. 6. Appellants argue that
Urquhart is directed to oral medication and, as such, it is "antithetical" to
local drug delivery, such as in Cima. Id. at 7. Appellants argue that oral
drug forms and implantable devices have different requirements in terms of
size, geometry, sterility, materials of construction, and means and routes for
deploying/removing devices from the body. Id. at 8. Appellants emphasize
that such differences are "not trivial." Id. Appellants characterize the
Examiner's contrary position as "wholly illogical" and a "wildly unrealistic
simplification of drug delivery." Id. at 8, Reply Br. 7.
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In response, the Examiner states that Cima and Urquhart each disclose
osmotic delivery. Ans. 14. The Examiner points out that Urquhart is merely
relied on to teach formulating the drug in the form of tablets as opposed to a
single drug rod. Id. The Examiner directs our attention to paragraph 67 of
Cima as suggesting alternatives to drug rods. Id.
A reference qualifies as prior art for an obviousness determination
when it is analogous to the claimed invention. Innovention Toys, LLC. v.
MGA Ent., Inc., 637 F.3d 1314, 1321 (Fed. Cir. 2011). "Two separate tests
define the scope of analogous art: (1) whether the art is from the same field
of endeavor, regardless of the problem addressed, and (2) if the reference is
not within the field of the inventor's endeavor, whether the reference still is
reasonably pertinent to the particular problem with which the inventor is
involved." In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). The "field of
endeavor" test asks if the structure and function of the prior art is such that it
would be considered by a person of ordinary skill in the art because of
similarity to the structure and function of the claimed invention as disclosed
in the application." Id. at 1325-26. "A reference is reasonably pertinent ...
if it is one which, because of the matter with which it deals, logically would
have commended itself to an inventor's attention in considering his
problem." In re Clay, 966 F.2d 656, 659 (Fed. Cir. 1992). "If a reference
disclosure has the same purpose as the claimed invention, the reference
relates to the same problem, and that fact supports use of that reference in an
obviousness rejection." Id. Whether a prior art reference is "analogous" is a
question of fact. Id. at 658.
Cima is directed to an implantable medical device for controlled drug
delivery within the bladder. Cima, Abstract. Cima shares a co-inventor
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Application 12/825,215
(Lee) with the instant application and shares substantially similar, if not
identical, drawings. Compare Cima, Figs. 1, 2, and 6, with Appellants'
Figs. 1, 2, and 9. Urquhart is directed to a drug delivery system comprising
a wall that surrounds an internal space that holds a plurality of tiny osmotic
delivery devices, each of which comprises a semipermeable wall, a soluble
agent that exhibits an osmotic pressure gradient across the semipermeable
wall, and an osmotic passageway for delivering a drug formulation over
time. Urquhart, claim 1. Urquhart's device is delivered orally to the body.
Id. col. 3, 1. 4.
We do not find Appellants' non-analogous art arguments persuasive.
Cima and Urquhart are both from the pharmaceutical field and both are
related to delivery devices for the time released administrative of drugs.
Appellants' point that different considerations come into play depending on
the route of administration ( oral or local) is well taken, however, Appellants'
position focuses too narrowly on such differences and ignores a host of
considerations that are common across various delivery techniques including
the use of osmotic delivery techniques in both references. In our opinion,
Urquhart satisfies the first or "field of endeavor" prong of the Bigio two step
analysis. Bigio, 381 F.3d at 1325.
Appellants' position on the second or "reasonably pertinent to the
particular problem with which the inventor is involved" prong of the Bigio
analysis is even less persuasive. Appellants never identify, much less
analyze and discuss, what the "particular problem" is that the inventor is
involved with in this application. See generally Appeal Br., Reply Br. In
the absence of Appellants identifying their "problem," we deem the problem
as relating to effectively sizing and shaping drugs for delivery through an
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Application 12/825,215
intravesical device. In that regard, we note that the Examiner only relies on
Urquhart for the size and shape of a plurality of tablets. Final Action 2-3.
Both Cima and Appellants' invention entail implantation into the
bladder by insertion through the urinary tract. See Spec. 57, Fig. 19; Cima,
,r 62. After insertion into the bladder, the device assumes a different shape
profile. See Cima Fig. 1, 2. In other words, during delivery the device is
substantially linear, but after delivery, the device assumes a more curvilinear
shape. A person of ordinary skill in the art would have no difficulty in
foreseeing that using a plurality of individual tablets would facilitate the
device undergoing a change in shape profile, which relates to potential
problems attendant upon elongated drug rods being resistive to bending
forces. See Figs. 3, 4. Formulating drugs into tablets is hardly new to the
pharmaceutical industry. Appellants present neither evidence nor persuasive
technical reasoning that formulating drugs for bladder therapy into tablet
size and shape requires more than ordinary skill.
It is well settled that familiar items may have obvious uses beyond
their primary purposes, and a person of ordinary skill often will be able to fit
the teachings of multiple patents together like pieces of a puzzle. KSR Int 'l
Co. v. Teleflex Inc., 550 U.S. 398, 420 (2007). Thus, it is not necessary for
the prior art to serve the same purpose as that disclosed in Appellants'
Specification in order to support the conclusion that the claimed subject
matter would have been obvious. See In re Lintner, 458 F.2d 1013, 1016
( CCP A 1972 ). Thus, a "reference may be read for all that it teaches,
including uses beyond its primary purpose." In re Mouttet, 686 F.3d 1322,
1331 (Fed. Cir. 2012), citing KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398,
418--421 (2007). Here, Urquhart teaches the delivery of drugs in tablet
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form. A person of ordinary skill in the art would have no difficulty in
adopting tablet forms to alternative delivery devices and modalities.
Appellants next argue that the Examiner's stated reason for combining
Cima and Urquhart uses "unreasonably high level abstraction" and is
"unduly generalized and conclusory." Appeal Br. 10. However, Appellants
concede that Cima already suggests that drug formulations can take forms
other than drug rods. Id. Essentially, Appellants argue that, because Cima
already discloses methods and means for customizing and controlling drugs,
a person of ordinary skill in the art would have no reason to modify Cima
with the teachings of Urquhart. Id. at 11.
In response, the Examiner notes that Cima already discloses various
ways of modifying the delivery such that Urquhart merely discloses yet
another alternative which effectively gives a user "more options" thereby
providing a reason for combining. Ans. 15.
Appellants' arguments are not persuasive. The Supreme Court
instructs us to take an expansive and flexible approach in determining
whether a patented invention was obvious at the time it was made. See KSR
Int'! Co. v. Teleflex Inc., 550 U.S. 398,415 (2007). A reason to modify a
prior art reference may be found explicitly or implicitly in market forces;
design incentives; the "interrelated teachings of multiple patents"; "any need
or problem known in the field of endeavor at the time of invention and
addressed by the patent"; and the background knowledge, creativity, and
common sense of the person of ordinary skill. Perfect Web Techs., Inc. v.
InfoUSA, Inc., 587 F.3d 1324, 1328-29 (Fed. Cir. 2009) (quoting KSR, 550
U.S. at 418-21 ). The existence of a reason for a person of ordinary skill in
the art to modify a prior art reference is a question of fact. See In re Constr.
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Equip. Co., 665 F.3d 1254, 1255 (Fed. Cir. 2011). Here, the Examiner
reasons that Urquhart provides a user with "more options" in designing a
delivery profile. Ans. 15. This is sufficient rationale to support the
rejection.
Appellants argument that Cima already discloses alternatives and,
therefore, does not need further modification is unpersuasive. The fact that
the prior art may already perform adequately does not preclude a skilled
artisan from seeking to improve upon it. See Dystar Textilfarben GmBH &
Co, v. CH Patrick Co., 464 F.3d 1356, 1368 (Fed. Cir. 2006) (explaining
that the desire to enhance commercial opportunities by improving a product
or process is universal-and even common-sensical).
We have considered Appellants' remaining arguments and find them
to be without merit. Accordingly, we sustain the Examiner's unpatentability
rejection of claim 1--4, 9--11, 26, 27, 30, 32, and 44--49.
Claims 33-36, 38, 39, and 41
Appellants argue the plurality of solid drug unit limitations of
claims 33-36 as a sub-group and then separately argue the solubilize
limitations of claims 33-36, 38, 39, and 41 as a separate sub-group. Appeal
Br. 12-14 (sub-headings 3 and 4). We select claim 33 as representative of
both sub-groups.
The solid drug unit limitations
Appellants argue that the proposed combination fails to satisfy the
limitation in independent claim 33 directed to solid drug units adjacent to
each other. Appeal Br. 12-13. In response, the Examiner points out that
such argument is addressed in connection with claim 1. Ans. 15.
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Figures la and lb of Urquhart show solid tablets in a delivery vehicle.
Urquhart, Figs. 1 a, 1 b. Appellants' argument is without merit.
The so/ubilize limitations
Appellants argue that Urquhart fails to teach or suggest solubilizing
solid drug units within the drug reservoir lumen. Appeal Br. 13, Reply
Br. 12. In response, the Examiner points out that the plurality of tablets
proposed in the combination result in the drug being solubilized in the drug
reservoir lumen of Cima. Ans. 16.
Appellants' argument amounts to an attack on a single reference in a
two reference, combination rejection. It is well established that non-
obviousness cannot be established by attacking references individually
where the rejection is based upon the teachings of a combination of
references. In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986); In re
Keller, 642 F.2d 413,425 (CCPA 1981).
We understand the rejection as merely entailing reshaping Cima' s
drug into the tablet shape taught by Urquhart. The proposed combination
teaches the limitation in dispute. Appellants present neither evidence nor
persuasive technical reasoning that modifying Cima's drug to assume a
tablet size and shape requires more than ordinary skill or produces
unexpected results.
We sustain the Examiner's rejection of claims 33-36, 38, 39, and 41.
Unpatentability of Claim 5
over Cima, Urquhart, and Lieb
Claim 5 depends from claim 1 and adds the limitation: "wherein the
drug tablets comprise lidocaine base." Claims App. The Examiner relies on
Lieb as satisfying this limitation. Final Action 9.
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Appellants argue that Lieb is non-analogous art as it is directed to
injectable formulations that have different design considerations than the
instant invention. Appeal Br. 14. The Examiner responds that Lieb uses the
same drug as Appellants. Ans. 16. We further note that Cima expressly
discloses delivery of lidocaine to the bladder. Cima, Fig. 16, ,r,r 57, 97.
Appellants present neither evidence nor persuasive technical
reasoning that preparing lidocaine base in tablet form for delivery in Cima's
system requires more than ordinary skill or produces unexpected results.
We are not apprised of error and, therefore, sustain the Examiner's rejection
of claim 5.
Unpatentability of Claims 6-8, 28, 29, 42, 43, and 50-54
over Cima, Urquhart, and Matsuura
Appellants argue claims 6-8, 28, 29, 42, 43, and 50-54 as a group.
Appeal Br. 15-1 7. We select independent claim 6 as representative.
In this ground of rejection, the Examiner relies on Matsuura for
teaching an intravesical device in which the drug reservoir tube and the
retention frame tube are aligned along their entire lengths. Final Action 11.
Appellants assign error to the Examiner's finding regarding the tubes
being aligned along their lengths. Appeal Br. 15-16. Among other things,
Appellants argue that Matsuura lacks two different tubes as claimed. Id.
at 16. According to Appellants, Matsuura has a single tube, namely,
pressure member 16. Id.
In response, the Examiner states that linear resistor 56, which is
disposed inside of impervious coating 62, forms a drug reservoir. Ans. 16.
In reply, Appellants argue that linear resistor 56 cannot be considered a drug
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Application 12/825,215
reservoir. Reply Br. 14. Appellants further argue that linear resistor 56 is
not capable of containing a plurality of drug tablets. Id. at 14--15.
Matsuura is directed to an intravesical infuser that is implanted into
the bladder. Matsuura, Abstract. With reference to a Figure 3 embodiment,
Matsuura teaches that:
[T]he distal end 14 of the infuser 10 provides controlled release
of the drug from the pressure member 16 by means of the distal
opening 32. In the illustrated embodiment, a linear resistor 56
is provided to control the flow of fluid from the interior of the
pressure member 16 through the distal opening 32.
Id. col. 9, 11. 52---60. Matsuura further teaches use of tensile member 34 that
is disposed within pressure member 16, but outside of impervious
coating 62. Id. col. 7, 11. 54--58, Figs. 3, 3A. As linear resistor 56 is
disposed inside of pressure member 16, the Examiner's finding that
Matsuura discloses tubes that align along their length is supported by a
preponderance of the evidence.
As for Appellants' argument that linear resistor 56 cannot hold a
plurality of drug tablets, we note, for reasons previously discussed, that
claim elements directed to holding a plurality of drug tablets are satisfied by
Cima as modified by Urquhart. Appellants' attack on Matsuura holding
tablets is viewed as yet another individual attack on a single reference.
Merck, 800 F.2d at 1097; Keller, 642 F.2d at 425. Contrary to Appellants'
position, the obviousness inquiry does not ask "whether the references could
be physically combined but whether the claimed inventions are rendered
obvious by the teachings of the prior art as a whole." In re Etter, 756 F.2d
852, 859 (Fed. Cir. 1985) (en bane). Here, Appellants present neither
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evidence nor persuasive technical reasoning that aligning two tubes along
their length requires more than ordinary skill or produces unexpected results.
In view of the foregoing discussion, we determine the Examiner's
findings of fact are supported by a preponderance of the evidence and that
the Examiner's legal conclusion of unpatentability is well-founded.
Accordingly, we sustain the Examiner's unpatentability rejection of
claims 6-8, 28, 29, 42, 43, and 50-54.
Unpatentability of Claim 31
over Cima, Urquhart, and Lennox
Claim 31 depends directly from claim 30 and indirectly from claim 1
and adds the limitation: "wherein the drug comprises gemcitabine," for
which the Examiner relies on Lennox. Claims App., Final Action 13-14.
The Examiner concludes that it would have been obvious to a person of
ordinary skill in the art at the time of the invention to modify Cima to deliver
gemcitabine. Id. According to the Examiner, a person of ordinary skill in
the art would have done this to treat cancer. Id.
Appellants argue that Lennox discloses injecting therapeutic agents
which is different from intravesical drug delivery. Appeal Br. 18. However,
Appellants present neither evidence nor persuasive technical reasoning that
adapting gemcitabine for intravesical tablet form delivery requires more than
ordinary skill or achieves unexpected results.
Appellants' argument does not apprise of Examiner error and,
therefore, we sustain the rejection of claim 31.
The Lee Declaration
Appellants rely on declaration testimony from one of the inventors,
Heejin Lee. See e.g., Appeal Br. 17, Reply Br. 16. We have considered
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Mr. Lee's testimony, but find that it does not affect the outcome. Submitting
invention is less persuasive than one made by a disinterested person." In re
McKenna, 203 F.2d 717, 720 (CCI\\ 1953). In particular, we find Mr. Lee's
testimony in paragraph 3 of the Declaration to the effect that Cima does not
suggest a device containing a plurality of drug tablets incomplete. Lee Deel.
,r 3. Cima expressly discloses that "other configurations are possible"
besides a solid drug rod. Cima ,r 67. In our opinion, forming and shaping
the drug into a plurality of tablets would have been considered by a person
of ordinary skill in the art as a likely candidate for one "other consideration"
under paragraph 67. Mr. Lee is a named co-inventor on the Cima patent
and, therefore, should be intimately familiar with its contents. Lee Deel. ,r 2.
Considering the importance of paragraph 67 as it relates to suggesting
alternative forms of drug formulation to a person of ordinary skill in the art
practicing Cima, Mr. Lee's failure to address this aspect of Cima in his
declaration is ample reason to discount his credibility and afford his
declaration little weight in our analysis.
DECISION
The decision of the Examiner to reject claims 1-11, 26-36, 38, 39,
and 41-54 is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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