Ex Parte Bodmeier

Board of Patent Appeals and Interferences

Mar 8, 2010

10378733 (B.P.A.I. Mar. 8, 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.
10/378,733 03/04/2003 Roland Bodmeier BOD-4 4352
24039 7590 03/08/2010
INNOVAR, LLC
P O BOX 250647
PLANO, TX 75025
EXAMINER
VU, JAKE MINH
ART UNIT PAPER NUMBER
1618
MAIL DATE DELIVERY MODE
03/08/2010 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 ROLAND BODMEIER
__________

Appeal 2009-014588
Application 10/378,733
Technology Center 1600
__________

Decided: March 8, 2010
__________

Before ERIC GRIMES, FRANCISCO C. PRATS, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a kit for
making extended release particles. The Examiner has rejected the claims for
indefiniteness, anticipation, obviousness, and obviousness-type double
patenting. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

Appeal 2009-014588
Application 10/378,733

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STATEMENT OF THE CASE
The Specification states that “[c]ommercially available biodegradable
microparticle products . . . consist of a dry powder of the microparticles and
an aqueous suspension vehicle, which is stored separately” (Spec. 2: 22-28).
The Specification states that “[t]his storage form requires a reconstitution
step just prior to administration. The suspension of the microparticles and
the subsequent injection can also cause difficulties due to agglomeration of
the particles, residual microparticles in the syringe, clogging of the needle,
etc.” (Id. at 3: 7-10.)
The Specification discloses a “composition with extended release of
an active compound in the form of a dispersion of extended release particles,
wherein the extended release particles are formed by mixing at least two
liquid preproducts” (id. at 4: 5-7). The Specification states that the
composition can be made, for example, “from a drug-containing solution of
poly(lactide-co-glycolide) in a biocompatible solvent such as ethylacetate as
the first liquid preproduct in one syringe and a separately stored aqueous
dispersion vehicle . . . in a second syringe. The particle dispersion is formed
prior to administration by mixing the two liquid preproducts through a
connector.” (Id. at 8: 11-16.)
Claims 10, 13-16, 18, 20, and 38-49 are on appeal. Claim 38 is the
only independent claim on appeal and reads as follows:
38. A kit for the preparation of a ready-to-use single- or multi-dose
dispersion of extended release solidified particles, the kit comprising at least
two liquid preproducts each of which is present in a portion for the
preparation of a single- or multi- dose composition; wherein
a. at least two of the preproducts are liquid and wherein the extended
release solidified particles are formed by mixing the preproducts;
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b. a first liquid preproduct comprises a carrier material that solidifies
in a second liquid preproduct prior to administration to a subject to form the
extended release solidified particles and, optionally, a biocompatible solvent
or solvent mixture;
c. a second liquid preproduct comprises a biocompatible liquid within
which the first liquid preproduct forms the extended release solidified
particles prior to administration to a subject; and
d. one or more active compounds are independently included in the
first liquid preproduct and/or the second liquid preproduct.

The claims stand rejected as follows:
• Claims 13, 14, 16, and 42 under 35 U.S.C. § 112, second paragraph,
as indefinite (Ans. 5);
• Claims 10, 13-16, 18, 20, and 38-49 for obviousness-type double
patenting based on the claims of Bodmeier1 (id. at 4);
• Claims 10, 13-16, 20, and 38-49 under 35 U.S.C. § 102(e) or
alternatively under 35 U.S.C. § 103(a) based on Dunn ‘846,2 including its
incorporation by reference of Dunn ‘2013 (id. at 6); and
• Claims 10, 13-16, 18, 20, and 38-49 under 35 U.S.C. § 103(a) based
on Dunn ‘846, Dunn ‘201, and Dunn ‘1154 (id. at 8).
I.
Issue
The Examiner has rejected claims 13, 14, 16, and 42 under 35 U.S.C.
§ 112, second paragraph, on the basis that the term “derivative” is unclear

1 Bodmeier, US 7,303,756 B1, Dec. 4, 2007
2 Dunn et al., US 2004/0127846 A1, July 1, 2004
3 Dunn et al., US 5,278,201, Jan. 11, 1994
4 Dunn et al., US 5,945,115, Aug. 31, 1999
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Application 10/378,733

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because, “[f]or example, carbon dioxide could theoretically be derived from
the combustion of acrylic acid-derivative” (Ans. 5).
Appellant contends that “derivative,” as used in the chemical field,
means “a compound that is obtained by chemical modification of a parent
compound such that the ‘derivative’ includes within it almost all or all of the
chemical structure of the parent (or base) compound” (Appeal Br. 13,
emphasis omitted). Appellant cites four dictionary definitions in support of
his position (id.). Appellant contends that those skilled in the art recognize
that there must be “substantial chemical structure similarity between the
parent (base) compound and the derivative” (id.).
The issue with respect to this rejection is: Has the Examiner shown
that the scope of the claims is indefinite because they recite “derivatives” of
certain compounds?
Principles of Law
“A claim is indefinite if, when read in light of the specification, it
does not reasonably apprise those skilled in the art of the scope of the
invention.” Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313,
1342 (Fed. Cir. 2003).
“[T]he definiteness of the language employed must be analyzed—not
in a vacuum, but always in light of the teachings of the prior art and of the
particular application disclosure as it would be interpreted by one possessing
the ordinary level of skill in the pertinent art.” In re Moore, 439 F.2d 1232,
1235 (CCPA 1971).
“[B]readth is not to be equated with indefiniteness.” In re Miller, 441
F.2d 689, 693 (CCPA 1971).
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Analysis
Appellant has provided evidence that, as used in the chemical field, a
“derivative” is a compound that shares structural similarity with the parent
(or base) compound. Appellant’s definitions do not include the precise
degree of similarity that defines a “derivative,” but the fact that the term has
an art-accepted meaning is itself evidence that those skilled in the art are
capable of recognizing a derivative compound when they see one. The
evidence that the Examiner cites in support of his position – a general
dictionary definition that also requires structural relatedness – does not
persuade us that those skilled in the art would not be able to determine
whether a given product was or was not encompassed by the claims. And
even the Examiner’s interpretation – that CO2 could be considered a
“derivative” of acrylic acid – would make the claims very broad, but not
indefinite.
Conclusion of Law
The Examiner has not shown that the scope of the claims is indefinite
because they recite “derivatives” of certain compounds.
II.
Issue
The Examiner has rejected claims 10, 13-16, 18, 20, and 38-49 for
obviousness-type double patenting based on the claims of Bodmeier (id. at
4). The Examiner has also rejected claims 10, 13-16, 20, and 38-49 under
35 U.S.C. § 102(e), or alternatively under 35 U.S.C. § 103(a), based on
Dunn ‘846, including its incorporation by reference of Dunn ‘201 (id. at 6)
and has rejected claims 10, 13-16, 18, 20, and 38-49 under 35 U.S.C.
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Application 10/378,733

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§ 103(a) based on Dunn ‘846, Dunn ‘201, and Dunn ‘115 (id. at 8). Since
the same issue is dispositive to all three rejections, we will address them
together.
The Examiner finds that Bodmeier’s claims “recite a kit for the
preparation of a composition comprising a carrier phase, which forms an
implant or particles in a body, on a body or under physiological conditions”
(Ans. 4). The Examiner concludes that “[i]t would have been obvious for
the person of ordinary skill in the art to combine the polylactide [carrier] and
solvent in a kit, because it would require one less separate chamber” (id. at
4-5).
The Examiner finds that Dunn ‘846 discloses a dual-chamber syringe
system that can mix two liquids, including the drug delivery system of Dunn
‘201, which is incorporated by reference into Dunn ‘846 (Ans. 7). The
Examiner finds that Dunn ‘201 discloses “a first liquid preproduct
comprised of a carrier material, such as polylactide . . . , and a biocompatible
solvent, such as ethanol or NMP . . . ; a second liquid preproduct, such as
water (see col. 5, line 50-51); and an active compound” (id.). The Examiner
concludes that “the prior art’s syringe coupling kit contain[s] the same
content as claimed by Applicant” (id.). The Examiner relies on Dunn ‘115
only for the suggestion of a release modifying agent, as recited in claim 18
(id. at 8).
With respect to the double-patenting rejection, Appellant contends
that the claims require “two liquid preproducts that form an extended release
ready-to-use dispersion of solidified particles PRIOR TO administration to a
subject” (Appeal Br. 10), while Bodmeier “requires a liquid polymer-
containing carrier phase . . . [that] solidifies and forms an implant or
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particles AFTER administration to a subject. The combinations of materials
required to meet the limits of each claimed invention differ.” (Id.)
With respect to the prior art rejections, Appellant contends that Dunn
‘846 and Dunn ‘201 do not disclose kits that include a second liquid
preproduct (Appeal Br. 17). Appellant contends “Dunn requires
coagulation/precipitation of the polymer after administration (outside of the
syringe) rather than prior to administration (within the syringe)” (id. at 18-
19), so that “when the polymer solution is injected into a subject . . . , the
water present in the physiological environment extracts the water-miscible
solvent from the polymer solution thereby affecting formation of a solid
implant” (id. at 18, emphasis omitted).
The issue with respect to each of these rejections is: Has the
Examiner shown that the cited references disclose or make obvious a kit that
comprises both a liquid composition that solidifies when exposed to a
second liquid composition, and the second liquid composition?
Findings of Fact
1. Bodmeier claims a “system for forming solid microparticles or a
solid implant in a subject” that comprises an “administrable dispersion
compris[ing] a liquid polymer-containing carrier phase dispersed within a
second phase,” where “the polymer-containing carrier phase in the
dispersion solidifies and forms the solid microparticles or a solid implant
after administration to a subject” (Bodmeier, col. 10, ll. 24-44).
2. Dunn ‘846 discloses a “coupling syringe system . . . [that] allows
for the effective mixing of compositions immediately prior to
administration” (Dunn ‘846 2, ¶ 19).
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3. Dunn ‘846 discloses that “[e]ach composition to be combined with
a syringe can independently be a solid, liquid, or mixture thereof” (id. at 3, ¶
32).
4. Dunn ‘846 discloses that “[a]ny suitable drug delivery system can
be employed. A suitable drug delivery system . . . is the Atrigel® delivery
system mixed with doxycycline or leuprolide acetate. The Atrigel® system
is described in U.S. Pat. No. 5,278,210, the disclosure of which is
incorporated herein by reference.” (Id. at 3-4, ¶ 34.)
5. Dunn ‘201 discloses that its products use “biodegradable polymers
as prosthetic implants and controlled-release, drug-delivery systems which
can be administered as liquids via, for example, a syringe and needle, but
which coagulate or cure (‘set’) shortly after dosing to form a solid” (Dunn
‘201, col. 2, ll. 54-58).
6. Dunn ‘201 discloses that “a solid, linear-chain, biodegradable
polymer or copolymer is dissolved in a solvent. . . . Once the polymer
solution is placed into the body where there is sufficient water, the solvent
dissipates or diffuses away from the polymer, leaving the polymer to
coagulate or solidify.” (Id. at col. 2, ll. 62-68.)
7. Dunn ‘201 discloses that, through its system, “the advantages of
liquid application are achieved. For example, the polymer may be injected
via syringe and needle into a body while it is in liquid form and then left in-
situ to form a solid biodegradable implant structure. The need to form an
incision is eliminated.” (Id. at col. 3, ll. 60-64.)
8. Dunn ‘201 discloses that “the higher molecular-weight polymers
will normally tend to coagulate or solidify faster than the very low-
molecular-weight polymers. . . . The higher molecular-weight polymer
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solution coagulates immediately when placed into water.” (Id. at col. 5, ll.
34-51.)
Principles of Law
“Obviousness-type double patenting is a judge-made doctrine that . . .
requires rejection of an application claim when the claimed subject matter is
not patentably distinct from the subject matter claimed in a commonly
owned patent” In re Berg, 140 F.3d 1428, 1431 (Fed. Cir. 1998).
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros., Inc. v. Union Oil Co., 814 F.2d 628, 631
(Fed. Cir. 1987).
Obviousness under 35 U.S.C. § 103 requires there to be “a reason that
would have prompted a person of ordinary skill in the relevant field to
combine the elements in the way the claimed new invention does.” KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
Analysis
Bodmeier claims a system for forming solid implants or particles in a
subject by administering a liquid polymer-containing composition that then
solidifies in the subject after administration (FF 1). Dunn ‘846 discloses a
syringe-coupling system that allows mixing of compositions, including the
composition of Dunn ‘201, before administration (FFs 2, 4). Dunn ‘201
discloses that its composition, like Bodmeier’s, is administered as a liquid
and solidifies after it is exposed to water in the body (FFs 5, 6). Dunn ‘201
discloses that administering its composition as a liquid has the advantage of
not requiring an incision to be made (FF 7).
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Application 10/378,733

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The Examiner finds that Dunn ‘201 discloses a system that includes
“a second liquid preproduct, such as water (see col. 5, line 50-51)” (Ans. 7).
That finding, however, is not supported by the reference. The relevant
passage is reproduced above (FF 8). Read in context, the cited passage
states that higher-molecular weight polymers will coagulate more quickly
when exposed to water, as they would be after injection, compared to lower-
molecular weight polymers. The cited passage does not disclose or suggest
combining, outside the body, a polymer-containing composition with an
aqueous composition that would cause it to solidify.
None of Bodmeier, Dunn ‘846, or Dunn ‘201 expose their
compositions to water, or another solidification-inducing liquid, before
administering the composition to a subject. The Examiner has not identified
a reason that would have prompted a person of ordinary skill in the art to
combine the composition claimed by Bodmeier or disclosed by the Dunn
references with a liquid that would cause solidification of the prior art
compositions, as required by the claims on appeal. The Examiner relies on
Dunn ‘115 only for its teaching of the release-modifying agent recited in
claim 18 (Ans. 8) and does not identify any teaching in Dunn ‘115 that
would remedy the deficiency of Dunn ‘846 and Dunn ‘201.
Conclusion of Law
The Examiner has not shown that the cited references disclose or
make obvious a kit that comprises both a liquid composition that solidifies
when exposed to a second liquid composition, and the second liquid
composition.
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SUMMARY
We reverse the rejection under 35 U.S.C. § 112, second paragraph, the
rejection for obviousness-type double patenting; and the rejections based on
Dunn ‘846, Dunn ‘201, and Dunn ‘115.

REVERSED

lp

INNOVAR, LLC
P O BOX 250647
PLANO TX 75025