Ex Parte Srinivas et al

Board of Patent Appeals and Interferences

Aug 31, 2011

11916685 (B.P.A.I. Aug. 31, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ARUTLA SRINIVAS, HARSHAL P. BHAGWATWAR,
VAKATI VENKAT ARVIND, SARAVANA PERUMAL,
VEMULA SATHYA NARAYANA,
MANDAVALLI SRIRAMA SARVESWARA RAO,
VENKATESWARLU VOBALABOINA, and
NOOKARAJU VENKATA SREEDHARALA
__________

Appeal 2011-004836
Application 11/916,685
Technology Center 1600
__________

Before ERIC GRIMES, LORA M. GREEN, and
MELANIE L. McCOLLUM, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner‟s rejection of claims 1-20 and 27-31. We have jurisdiction under
35 U.S.C. § 6(b).
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STATEMENT OF THE CASE
Claim 1 is representative of the claims on appeal, and reads as
follows:
1. Substantially non-porous polymeric microparticles comprising a
hydrophobic polymer and a plasticizer, containing therein a bioactive
or bioinactive agent, the microparticles containing surface pores,
internal pores, or both, but having substantially no internal porosity
connecting with the surface.

The following grounds of rejection are before us for review:
I. Claims 1-20 and 27-31 stand rejected under 35 U.S.C. § 112,
second paragraph, as being indefinite.
II. Claims 1, 4-9, and 11-20 stand rejected under 35 U.S.C. § 102(b)
as being anticipated by Lo.
1

III. Claim 2 stands rejected under 35 U.S.C. § 103(a) as being rendered
obvious by the combination of Lo and Straub.
2

IV. Claim 3 stands rejected under 35 U.S.C. § 103(a) as being rendered
obvious by the combination of Lo and Wright.
3

V. Claim 10 stands rejected under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Lo and Oshlack.
4

VI. Claims 27-29 stand rejected under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Lo and Cattaneo.
5

1
Lo, US 5,725,869, Mar. 10, 1998.
2
Straub et al., US 6,395,300 B1, May 28, 2002.
3
Wright et al., US 2005/0271702 A1, Dec. 8, 2005.
4
Oshlack et al., US 2002/0010127 A1, Jan. 24, 2002.
5
Cattaneo, US 2004/0247632 A1, Dec. 9, 2004.
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VII. Claim 30 stands rejected under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Lo and Wright.
VIII. Claim 31 stands rejected under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Lo and Wright as further
combined with Cattaneo.
We reverse.
ISSUE (Rejection I)
Has the Examiner established by a preponderance of the evidence that
the use of the phrases “substantially non-porous” and “the microparticle
containing surface pores, internal pores, or both, but having substantially no
internal porosity connecting with the surface” render the independent claims
on appeal indefinite?

FINDINGS OF FACT
FF1. The Specification teaches that the “invention relates to polymeric
microparticles containing one or more bioactive or bioinactive agents or
combinations thereof” (Spec. 1).
FF2. The Specification teaches that the “invention includes substantially
non-porous polymeric microparticles comprising a hydrophobic polymer and
a plasticizer, and containing therein a bioactive or bioinactive agent” (id. at
3).
FF3. According to the Specification:
The term “substantially nonporous” is intended to mean
microparticles that can have surface pores, internal pores, or
both, but generally lack an interconnected network of pores
open to the surface. Such a substantially non-porous product as
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defined by the porosity and pore volume is obtained by altering
the ratio of polymer to plasticizer and controlling the processing
parameters during the manufacture of the microparticle phase.
Thus, increasing the concentration of the plasticizer in the
microparticle composition will generally provide a product with
a lower porosity. Further, lower porosity can also be imparted
to the microparticle phase through slower drying and at ambient
temperatures. An elevated temperature for example can
enhance the rate of solvent evaporation, but result in a product
with a higher porosity.

(Id. at 5-6.)
FF4. The Specification teaches further:
Without being bound by any particular theory, the water-
insoluble plasticizer allows a reduction in the glass transition
temperature of the polymer or polymer combinations used in
the present invention, thus providing a microparticle that is not
completely rigid as would be expected with the neat polymer or
neat polymer combinations. The microparticle thus produced is
a species in-between a liquid droplet and a solid particle. It is
believed that the use of a water-insoluble plasticizer for the
polymer, because of this reduction in glass transition
temperature, allows for a substantially non-porous product to be
prepared, while at the same time allowing the microparticles to
retain enough mechanical strength to keep them in their original
shape during further processing and storage.

(Id. at 6.)
FF5. The Specification also teaches that the “surface areas and pore
volumes of the microparticles can be determined by B.E.T (Brunauer,
Emmett and Teller) nitrogen multipoint analysis using instruments such as
Quantachrome Autosorb automated gas sorption system, Langmuir
multipoint analysis, and other methods known to one skilled in the art” (id.
at 7).
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FF6. The Examiner‟s statement of the indefiniteness rejection may be
found at pages 4-6 of the Answer.
FF7. The Examiner notes that claims 1, 11, 20, and 30 recite the limitations
of “„substantially non-porous‟” and “„the microparticle containing surface
pores, internal pores, or both, but having substantially no internal porosity
connecting with the surface‟” (Ans. 4).
FF8. The Examiner finds that the “term „substantialy non-porous‟ is a
relative term which renders the claims indefinite” (id. at 5).
FF9. Specifically, the Examiner finds:
While a measurement of porosity per se is not considered
indefinite, the claims do not recite a measurable range from
which one of ordinary skill can ascertain whether said measured
values of porosity are within the scope of “substantially non-
porous” and “substantially no internal porosity connecting to
the surface.”

(Id.).

PRINCIPLES OF LAW
“Definiteness problems often arise when words of degree [e.g.,
“substantially”] are used in a claim.” Seattle Box Co., Inc. v. Indus. Crating
& Pkg., Inc., 731 F.2d 818, 826 (Fed. Cir. 1984). “That some claim
language may not be precise, however, does not automatically render a claim
invalid.” Id. When a word of degree is used, it must be determined whether
the Specification provides some standard for measuring that degree. Id.
Thus the issue is whether one of ordinary skill in the art would understand
what is claimed when the claim is read in light of the specification. Id.

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ANALYSIS
Appellants argue that the terms “„substantially non-porous‟ and
„substantially no internal porosity,‟ when viewed in light of the specification
and prior art, reasonably describe the claimed subject matter such that its
scope is readily understood by persons of skill in the art” (App. Br. 12).
Specifically, Appellants assert that the disclosure
teaches that substantially non-porous microparticles containing
surface pores, internal pores, or both, but having substantially
no internal porosity connecting with the surface can be defined
by porosity and pore volume and can be obtained by altering
the ratio of polymer to plasticizer and controlling the processing
parameters during the manufacture of the microparticle phase

(id.).
The Specification defines what is meant by “substantially non-porous”
and sets forth processes of forming such particles, and also teaches methods
for determining surface areas and pore volumes of the microparticles. Thus,
we agree with Appellants that the skilled artisan would understand the terms
“substantially non-porous” and “substantially no internal porosity” when
viewed in light of the Specification. That is, the ordinary artisan would
understand that the particles may have surface pores or internal pores, but
very few, if any, pores connecting the internal pores to the surface of the
particle.
Moreover, the Examiner's objection to the term “substantially” seems
to be based on the perception that the use of that term per se renders the
claim indefinite, as the Examiner did not explain why the ordinary artisan
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would not understand the metes and bounds of the claim in view of the
teachings of the Specification.
CONCLUSION OF LAW
We conclude that the Examiner has not established by a
preponderance of the evidence that the use of the phrases “substantially non-
porous” and “the microparticle containing surface pores, internal pores, or
both, but having substantially no internal porosity connecting with the
surface” render the independent claims on appeal indefinite.
We thus reverse the rejection of claims 1-20 and 27-31 under 35
U.S.C. § 112, second paragraph, as being indefinite.

ISSUE (Rejections II-VIII)
Has the Examiner established by a preponderance of the evidence that
Lo anticipates the substantially non-porous particle of claims 1 and 30, a
composition comprising a substantially non-porous particle as set forth in
claim 11, and a process for preparing a substantially non-porous particle as
set forth in claim 20?

FINDINGS OF FACT
FF10. The Examiner‟s statement of the anticipation rejection over Lo may
be found at pages 6-8 of the Answer.
FF11. The Examiner notes:
For the purposes of examination on the merits, any prior art
composition comprising microparticles, hydrophobic polymer,
plasticizer and bioactive or bioinactive agent will be considered
to meet the limitation of “substantially non-porous” and
“substantially no internal porosity connecting to the surface.”
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(Ans. 6.)
FF12. The Examiner cites Lo for teaching “compositions comprising
polymeric microspheres (a microparticle) containing a polymer and a
plasticizer (Abstract)” (id.).
FF13. The Examiner finds:
It is noted that the microspheres of Lo are taught to have
a highly porous surface and a highly porous internal structure
(column 5, lines 37 - 40). However, Lo teaches a microsphere
composition comprising the same elements as instantly
claimed. Furthermore, the microspheres of Lo are prepared
using the same process as claimed. Accordingly, Lo anticipates
the “substantially non-porous” microspheres recited in the
instant Claims.

(Id. at 8.)
FF14. The remaining references, i.e., Straub, Wright, Oshlack, and Cattaneo,
are cited in obviousness rejections to meet limitations of dependent claims
(see Ans. 9-15).

PRINCIPLES OF LAW
To anticipate, every element and limitation of the claimed invention
must be found in a single prior art reference, arranged as in the claim.
Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir.
2001).

ANALYSIS
Appellants argue that it was error for the Examiner to ignore the
limitations of “„substantially non-porous‟” and “„substantially no internal
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porosity connecting to the surface‟” in making the anticipation rejection
(App. Br. 16). We agree. As the Examiner admits, Lo teaches a highly
porous microparticle. We are thus compelled to reverse the rejection.

CONCLUSION OF LAW
We conclude that the Examiner has not established by a
preponderance of the evidence that Lo anticipates the substantially non-
porous particle of claims 1 and 30, a composition comprising a substantially
non-porous particle as set forth in claim 11, and a process for preparing a
substantially non-porous particle as set forth in claim 20.
We thus reverse the rejection of claims 1, 4-9, and 11-20 under 35
U.S.C. § 102(b) as being anticipated by Lo.
As the remaining references relied upon by the Examiner in the
obviousness rejections do not make up the deficiencies of Lo, we also
reverse the rejection of:
claim 2 under 35 U.S.C. § 103(a) as being rendered obvious by the
combination of Lo and Straub;
claim 3 under 35 U.S.C. § 103(a) as being rendered obvious by the
combination of Lo and and Wright;
claim 10 under 35 U.S.C. § 103(a) as being rendered obvious by the
combination of Lo and Oshlack;
claims 27-29 under 35 U.S.C. § 103(a) as being rendered obvious by the
combination of Lo and Cattaneo;
claim 30 under 35 U.S.C. § 103(a) as being rendered obvious by the
combination of Lo and Wright; and
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claim 31 under 35 U.S.C. § 103(a) as being rendered obvious by the
combination of Lo and Wright as further combined with Cattaneo.

REVERSED

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