Ex Parte Li et al

Board of Patent Appeals and Interferences

Sep 29, 2010

11125297 (B.P.A.I. Sep. 29, 2010)

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.
11/125,297 05/09/2005 Jamie Li 04-0074US1 9843
27774 7590 09/29/2010
MAYER & WILLIAMS PC
251 NORTH AVENUE WEST
2ND FLOOR
WESTFIELD, NJ 07090
EXAMINER
FRAZIER, BARBARA S
ART UNIT PAPER NUMBER
1611
MAIL DATE DELIVERY MODE
09/29/2010 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JAMIE LI and MICHAEL MADDEN
__________

Appeal 2010-007219
Application 11/125,297
Technology Center 1600
__________

Before CAROL A. SPIEGEL, TONI R. SCHEINER, and DONALD E. ADAMS,
Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims to an
injectable bulking composition. The claims have been rejected as obvious.
We have jurisdiction under 35 U.S.C. § 6(b).

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.

Appeal 2010-007219
Application 11/125,297

2
STATEMENT OF THE CASE
“The present invention relates to injectable bulking compositions for
medical and cosmetic applications” (Spec. ¶ 1), for example, “the treatment
[of] urinary incontinence . . . and aesthetic shaping (e.g., treatment of skin
contour deficiencies)” (id. at ¶ 14).
Claims 1-3, 5, 8-11, and 16-20 are pending and on appeal.2 Claims 1
and 20 are representative:
1. An injectable bulking composition comprising: (a) fibers that
are configured to prevent migration of the fibers to locations in the body
remote from the injection site, and (b) a carrier in an amount effective to
render the composition injectable.
20. The injectable bulking composition of claim 1, wherein said
fibers have surface features that stimulate host tissue response so as to
prevent migration.

The Examiner rejected claims 1-3, 5, 8-11, and 16-19 under 35 U.S.C.
§ 103(a) as unpatentable over Bucay-Couto.3
The Examiner also rejected claims 1 and 20 under 35 U.S.C. § 103(a)
as unpatentable over Hunter.4
We reverse.

2 Claims 4, 6, 7, 12-15, 21, and 22 are also pending, but have been
withdrawn from consideration (App. Br. 2).
3 Patent Application US 2005/0064008 A1 of Weenna Bucay-Couto et al.,
published March 24, 2005.
4 U.S. Patent 7,166,570 B2, issued January 23, 2007 to William L. Hunter
et al.
Appeal 2010-007219
Application 11/125,297

3
FINDINGS OF FACT
The Invention
1. All of the claims on appeal are directed to bulking compositions
comprising (a) fibers, and (b) a carrier in an amount effective to render the
composition injectable.
2. A bulking composition is used to add volume (i.e., bulk) to an
area of a subject’s body in need of augmentation (Spec. ¶¶ 1-5).
3. According to the Specification, “[a]s used herein, a ‘fiber’ is an
elongated particle having a length that is at least 10 times longer than the
greatest width of the particle . . . For instance, in the case of a cylindrical
fiber, the length is at least 10 times the diameter” (Spec. ¶ 15).
4. The Specification teaches that “[t]he carrier typically includes
one or more liquid species, for example, water, one or more liquid organic
species (e.g., glycerin or other alcohols), or a mixture of water and one or
more liquid organic species” (Spec. ¶ 24).
5. The Specification also teaches that “surface characteristics that
stimulate host tissue response to lock the fibers in position include surface
features, such as roughness and microscopic patterns, as well as coatings of
therapeutic agents” (Spec. ¶ 23).
Bucay-Couto
6. Bucay-Couto discloses an injectable solid or semi-solid dosage
form “for chemoablation of tissue, such as prostate tissue.” The dosage
forms comprise, as integral components, a biodisintegrable binder (e.g., a
polymer) and a chemical ablation agent (e.g., a salt), wherein the ablation
agent causes “necrosis (death) or shrinkage of nearby tissue upon injection
or insertion of the formulation into the tissue” (Bucay-Couto ¶¶ 1, 6, 14, 15).
Appeal 2010-007219
Application 11/125,297

4
7. Bucay-Couto’s biodisintegrable binder is one that, “once
injected or inserted into tissue such as the prostate, undergoes dissolution,
degradation, resorption and/or other disintegration processes . . . typically
[undergoing] . . . a 50-100% reduction in weight after residing in the tissue
for a period of 4 days” (Bucay-Couto ¶ 21).
8. According to Bucay-Couto, the solid or semi-solid dosage
forms “result . . . in improved dosage retention in the tissue (e.g., there is
little to no back-leakage into the injection tract), thereby improving delivery
efficiency of the ablation agents and/or minimizing . . . nonspecific tissue
damage” (Bucay-Couto ¶ 14).
9. Bucay-Couto’s dosage forms are made, e.g., by dissolving a
polymer (i.e., the biodisintegrable binder) in a saturated salt solution (i.e.,
the ablation agent), and extruding the resultant paste through a needle into
ethanol to form a rod/filament which is dried and cut to a desired length
(Bucay-Couto Example 1, ¶ 53).
10. Bucay-Couto teaches:
Because they are solid or semisolid in consistency, the
dosage forms . . . can be provided in an essentially unlimited
variety of shapes (e.g., spheres, cylinders, irregular shapes
including beads of various shapes) and sizes, ranging from
microparticles to pellets . . . As a more specific example,
cylindrical pellets can be provided, which have an outside
diameter ranging from 1 to 3 mm and a length ranging from 3
to 10 mm.
(Bucay-Couto ¶ 36.)

Appeal 2010-007219
Application 11/125,297

5
Hunter
11. Hunter discloses a “long-lasting and biocompatible approach
for anchoring implantable medical devices into or onto biological tissue”
(Hunter, col. 2, ll. 57-58).
12. Hunter provides “drug-coated or drug-impregnated implants
and medical devices . . . which induce adhesion or fibrosis in the
surrounding tissue, or facilitate ‘anchoring’ of the device/implant in situ”
(Hunter, col. 2, l. 66 to col. 3, l. 2).
13. The implants and devices are coated, impregnated, or in contact
with “a fibrosis-inducing agent or a composition comprising a fibrosis-
inducing agent” (Hunter, col. 3, ll. 43-44).
Exemplary fibrosis-inducing agents include . . . talcum powder,
metallic beryllium and oxides thereof, copper, silk, silica,
crystalline silicates, talc, quartz dust, and ethanol; . . .
fibronectin, collagen, fibrin, or fibrinogen; . . . polylysine,
poly(ethylene-co-vinylacetate), chitosan, N-carboxybutyl-
chitosan, and RGD proteins; vinyl chloride . . . cyanoacrylates
and crosslinked poly(ethylene glycol)-methylated collagen; . . .
TGFβ, PDGF, VEGF, bFGF, TNFα, NGF, GM-CSF, IGF-a, IL-
1, IL-8, IL-6, . . . CTGF; BMP . . . and bleomycin or an
analogue or derivative thereof.
(Id. at 4, ll. 48-63.)
14. Hunter discloses that the “the agent may be present in a
composition along with a polymer,” which may be biodegradable or not
(Hunter col. 4, ll. 35-39), or with a “bulking agent” or a sealant” (id. at 4, ll.
44, 47).
15. Hunter teaches that the silk “may be in any suitable form that
allows the silk to be joined with the medical implant, e.g., the silk may be in
thread or powder” form (Hunter, col. 9, ll. 16-17, 65-68).
Appeal 2010-007219
Application 11/125,297

6
16. Hunter also describes therapeutic methods involving injecting
“a composition comprising a fibrosis-inducing agent” into a vein, an artery,
a fallopian tube, a damaged joint, an intervertebral disc space, etc. (Hunter,
col. 5, ll. 16-60).

OBVIOUSNESS
Obviousness over Bucay-Couto
Claims 1-3, 5, 8-11, and 16-19 stand rejected as unpatentable over
Bucay-Couto.
The Examiner finds that Bucay-Couto discloses “solid or semi-solid
therapeutic formulations comprising a biodisintegrable binder and an
ablation agent which is injectable, and whereby retention at the site of
injection . . . is improved, thereby improving delivery efficiency” (Ans. 4).
According to the Examiner, “[t]he carrier may be a liquid such as a sodium
chloride solution . . . or the biodisintegrable binder, such as cellulose, may
also act as the carrier” (id.).
The Examiner acknowledges that Bucay-Couto doesn’t “specifically
teach that the biodisintegrable polymers are ‘fibers’ according to Applicant’s
definition in the specification” (Ans. 4), but concludes that “one skilled in
the art would be motivated to select cylindrical pellets having dimensions
according to Applicant’s definition of ‘fiber’ . . . by routine experimentation,
in order to optimize the retention at the site of injection to improve delivery
efficiency, as taught by Bucay-Couto” (id. at 5), especially as “the
biodisintegrable polymers of Bucay-Couto et al. ‘can be provided in an
essentially unlimited variety of shapes’” (id.).
Appeal 2010-007219
Application 11/125,297

7
Appellants contend that “the ‘injectable bulking composition’ of the
claim preamble does not merely state a purpose or an intended use of the
invention, but rather, discloses a fundamental characteristic of the claimed
invention that is properly construed as a limitation of the claim” (Reply Br.
4). Appellants contend “[t]here is simply no suggestion or motivation, either
in the Bucay-Couto reference itself or in the knowledge generally available
to one of ordinary skill in the art” (App. Br. 5 (emphasis omitted), “to take
the tissue-ablating formulations of Bucay-Couto et al., which very purpose is
to ‘result[ ] in necrosis (death) and shrinkage of nearby tissue upon
injection . . . and modify such formulations to create a bulking composition
that, instead of killing or shrinking nearby tissue, is an ‘augmentative
material’” (id. at 5-6). Appellants further contend that “a ‘fiber’ would
not be recognized by one of ordinary skill in the art as a type of ‘dosage
form’” (App. Br. 7), thus, “one of ordinary skill in the art would not find that
the variety of dosage forms described in Bucay-Couto et al., ‘spheres,
cylinders, [beads of] irregular shapes . . . and sizes, ranging from
microparticles to pellets’” would suggest fibers (id.).
Nevertheless, the Examiner asserts that Bucay-Couto’s dosage forms
are “capable of use as bulking compositions” (Ans. 8) because they are
“retained at the site of injection or insertion . . . [and] last[ ] for at least
several days, . . . [and] provide[ ] an increased mass or ‘bulk’ at the site of
injection” (id. at 9). As the Examiner sees it, “the question is not one of
modifying the formulation of Bucay-Couto . . . , but rather of selecting a
shape of ‘fiber’, as defined by Appellants, from what is already disclosed by
Bucay-Couto” (id. at 10).
Appeal 2010-007219
Application 11/125,297

8
Given these conflicting positions, the principle issue raised by this
rejection is whether the Examiner’s interpretation of Bucay-Couto’s
chemoablation dosage formulation as a “bulking composition” is reasonable
in the first place, given the evidence of record.
On this basic point, Appellants have the better position. Bucay-
Couto’s chemoablative dosage form contains an ablative agent as an integral
component, the express purpose of which is to shrink tissue, not to augment
it. Even if the dosage form is retained at the injection site for a period of
days, there is nothing to suggest that it adds bulk to the tissue because the
tissue around it is being ablated. Moreover, the shapes, e.g., cylinders,
disclosed by Bucay-Couto refer to the overall shape of the dosage form,
which is an integral mixture of a biodisintegrable polymer and an ablative
agent (e.g., Example 1, wherein the polymer is dissolved in a saturated salt
solution) (FF9). Even if the ablative agent is considered to be the “carrier”
required by the claims on appeal, there’s no suggestion in the reference that
the biodisintegrable polymer itself, which is blended with the carrier in an
intimate mixture, is in the form of a fiber, nor has the Examiner explained
why it would have been obvious to modify the shape of the polymer itself
within the solid or semi-solid dosage form.
On this record, we are constrained to reverse the rejection of claims
1-3, 5, 8-11, and 16-19 as unpatentable over Bucay-Couto.
Appeal 2010-007219
Application 11/125,297

9
Obviousness over Hunter
Claims 1 and 20 stand rejected as unpatentable over Hunter. Claim 20
depends from claim 1 and requires that the “fibers have surface features that
stimulate host tissue response so as to prevent . . . migration” of the fibers.
The Examiner finds that Hunter discloses “a composition comprising
a fibrosis-inducing agent and a bulking agent” (Ans. 7); and that the
“fibrosis-inducing agent may be growth factors” (id.); that “the therapeutic
agent may [be] formulated with a polymeric carrier” (id.); and that “[t]he
compositions may be injected” (id.). The Examiner also notes that Hunter
teaches that “fibrosis-inducing agents . . . such as silk . . . may be in the form
of strands and/or threads” (id.).
The Examiner acknowledges that Hunter doesn’t “specifically teach
that the bulking agent and/or growth factors are ‘fibers’” (Ans. 7). However,
the Examiner concludes that “it would have been obvious . . . to form an
injectable bulking composition comprising fibers and a carrier, thus arriving
at the claimed invention” (Ans. 7-8), “in order to optimize the promotion of
fibrosis” (id. at 8), because Hunter “fairly teach[es] and suggest[s] other
fibrosis-inducing agents in the form of strands and/or threads, such as silk”
and Hunter’s compositions are “injectable and capable of use as bulking
compositions” (id.).
Appellants contend that Hunter “teaches joining or otherwise
attaching raw silk threads to the surface of a medical implant in order to
promote[ ] adhesion between the implant and tissue” (App. Br. 9), and “does
not utilize fibers within an injectable bulking composition as required by the
present invention” (id.). Appellants further contend there is “no suggestion
or motivation, either in the Hunter et al. reference itself or in the knowledge
Appeal 2010-007219
Application 11/125,297

10
generally available to one of ordinary skill in the art, to modify the reference
or to combine reference teachings” (id. at 8 (emphases omitted)).
Given these conflicting positions, the issue raised by this rejection is
whether the Examiner has established that one of ordinary skill in the art
would have had a reason to include a fibrous fibrosis-inducing agent in an
injectable composition, given Hunter’s disclosure.
Again, Appellants have the better position. The Examiner has drawn
from disparate embodiments to assemble the components required by the
claims, without a reasoned explanation as to why one of ordinary skill in the
art would have combined those particular elements. It is true that Hunter
teaches that a composition comprising a fibrosis-inducing agent can be
injected into veins, etc., and also teaches that silk fibers are fibrosis-inducing
agents. But the Examiner has not explained why, out of the fifty or so
predominantly particulate fibrosis-inducing agents listed (FF13), one would
have selected silk, possibly the only fiber listed, to inject into a vein, when
Hunter specifically discusses silk fibers only as an attachment or coating for
an implanted device (FF15) (which is what Hunter is primarily directed to,
in any case).
On this record, we are constrained to reverse the rejection of claims 1
and 20 as unpatentable over Hunter.

Appeal 2010-007219
Application 11/125,297

11
SUMMARY
The rejection of claims 1-3, 5, 8-11, and 16-19 under 35 U.S.C.
§ 103(a) as unpatentable over Bucay-Couto is reversed.
The rejection of claims 1 and 20 under 35 U.S.C. § 103(a) as
unpatentable over Hunter is reversed.

REVERSED

alw

MAYER & WILLIAMS PC
251 NORTH AVENUE WEST
2ND FLOOR
WESTFIELD, NJ 07090