Puri, Sonali et al.

Patent Trials and Appeals Board

Dec 10, 2019

12341433 - (D) (P.T.A.B. Dec. 10, 2019)

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.
12/341,433 12/22/2008 Sonali Puri 4010/270 1897
121974 7590 12/10/2019
KACVINSKY DAISAK BLUNI PLLC
2601 Weston Parkway
Suite 103
Cary, NC 27513
EXAMINER
SPRINGER, STEPHANIE K
ART UNIT PAPER NUMBER
1629
NOTIFICATION DATE DELIVERY MODE
12/10/2019 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):
bbonneville@kdbfirm.com
docketing@kdbfirm.com
ehysesani@kdbfirm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SONALI PURI, ROBERT E. RICHARD, and JOHN E. O’GARA1
Appeal 2019-005006
Application 12/341,433
Technology Center 1600
Before ERIC B. GRIMES, TIMOTHY G. MAJORS, and
MICHAEL A. VALEK, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to
injectable particles, which have been rejected for lack of adequate written
description. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 Appellant identifies the real party in interest as Boston Scientific Scimed,
Inc. Appeal Br. 3. We use the word Appellant to refer to “applicant” as
defined in 37 C.F.R. § 1.42(a).
Appeal 2019-005006
Application 12/341,433

2
STATEMENT OF THE CASE
Claims 33–35 are on appeal. Claim 33, reproduced below, is
illustrative (emphasis added):
33. Injectable particles comprising (a) a first group of injectable
particles comprising first polymeric particles that comprise a
crosslinked particle-forming polymer comprising vinyl alcohol
monomer and a charged polymer comprising -SO3– groups
covalently bound to the particle-forming polymer, said first
group of injectable particles being loaded with doxorubicin HCl
and (b) a second group of injectable particles comprising
second polymeric particles that comprise a crosslinked particle-
forming polymer comprising vinyl alcohol monomer, said
second group of injectable particles being loaded with
doxorubicin HCl, wherein said second group of polymeric
particles do not comprise functional groups having a charge,
and wherein after a period of 12 hours in phosphate buffered
saline (PBS) with 0.05% wt/vol polysorbate 20 surfactant, pH
7.4, a percentage of doxorubicin HCl released by said second
group of injectable particles is at least 5 times greater than a
percentage of doxorubicin HCl released by said first group of
injectable particles.

Claim 35 is also independent and is directed to injectable particles
comprising first and second groups of particles having the same structural
limitations as recited in claim 33, and the following release characteristics:
wherein a percentage of doxorubicin HCl released by said
second group of injectable particles is 85–95% after a period of
2 hours in phosphate buffered saline (PBS) with 0.05% wt/vol
polysorbate 20 surfactant, pH 7.4, and wherein a percentage of
doxorubicin HCl released by said first group of injectable
particles is about 10% after a period of 24 hours in phosphate
buffered saline (PBS) with 0.05% wt/vol polysorbate 20
surfactant, pH 7.4.
Appeal 2019-005006
Application 12/341,433

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OPINION
Claims 33–35 stand rejected under 35 U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement. Ans. 3. The
Examiner notes that the claims recite release characteristics in “functional
descriptive language,” and finds that the Specification does not “provide
guidance to the ordinarily skilled artisan in arriving at particular polymers or
polymeric particles which would result in the recited release profile.” Id. at 7.
The Examiner finds that the Specification provides a working
example of particles having the structural properties recited in the claims and
the following release rates: “the doxorubicin-loaded fast-release particles
release 85–95% of the loaded drug in 2 hours, whereas the doxorubicin-
loaded slow-release particles release only 5% of the loaded drug in 2 hours,
and only 10% in 24 hours.” Id. at 9–10. The Examiner finds, however, that
“[t]here is no evidence of record demonstrating that Applicant was in
possession of other polymers or other polymeric particles, and there is no
disclosure which would suggest that the single disclosed embodiment is
representative of the entirety of the claimed genus.” Id. at 10.
The Examiner concludes that the Specification does not adequately
describe the claimed particles because
the claims are so broad and generic, with respect to all possible
polymers, particle-forming polymers, and polymeric particles
encompassed by the claims, the possible structural variations
are nearly infinite. Although the claims may recite some
functional characteristics, the claims lack written description
because there is no disclosure of a correlation between function
and structure of the compounds beyond the single disclosed
example in the specification. Moreover, the specification lacks
sufficient variety of species to reflect this variance in the genus.
Id. at 11.
Appeal 2019-005006
Application 12/341,433

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Appellant argues that, while the claims use “comprising” language
that encompasses additional, unrecited elements, they “are quite specific
with regard to what they do require, including a polymer comprising a vinyl
alcohol monomer as well as a polymer comprising a vinyl alcohol monomer
and a charged polymer comprising -SO3– groups.” Reply Br. 8. Appellant
argues that,
[g]iven the moderate scope of the claimed invention, . . . the
instant specification describes the claimed invention in
sufficient detail, including an actual reduction to practice, such
that one skilled in the art would reasonably conclude that the
inventors had possession of the claimed invention, which as can
be seen from claims 33 and 35 are tailored to the working
Example [in the Specification].
Id.
We agree with Appellant that the Examiner has not shown that those
skilled in the art would not have recognized from the Specification’s
description that Appellant was in possession of the claimed invention at the
time the instant application was filed. The Examiner “‘bears the initial
burden . . . of presenting a prima facie case of unpatentability.’ Insofar as the
written description requirement is concerned, that burden is discharged by
‘presenting evidence or reasons why persons skilled in the art would not
recognize in the disclosure a description of the invention defined by the
claims.’” In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996) (citations
omitted). “[T]he test . . . is whether the disclosure of the application relied
upon reasonably conveys to those skilled in the art that the inventor had
possession of the claimed subject matter as of the filing date.” Ariad
Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010)
(citations omitted).
Appeal 2019-005006
Application 12/341,433

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Here, the Specification describes the invention as injectable particles
comprising two groups of polymeric particles, each group being loaded with
a therapeutic agent, where the polymeric particles and/or the therapeutic
agents in each group can be the same or different. Spec. ¶ 6. The
Specification states that, when the polymeric particles are different and the
therapeutic agent is the same, “the first and second groups of particles . . .
can have a different release profile due to the difference in composition
between the first and second polymeric particles (e.g., one group may be
adapted for shorter term ‘burst’ release and the other may be adapted for
longer term ‘sustained’ release).” Id. ¶ 12. This scenario describes the
particles and release characteristics recited in the claims.
The Specification also provides a working example of “fast and slow
releasing doxorubicin HCl PVA-based microspheres.” Id. ¶ 104. “PVA” is
polyvinyl alcohol. Id. ¶ 47. The fast releasing microspheres were produced
by exposing Contour SE microspheres to a solution of doxorubicin HCl. Id.
¶ 104. The Specification describes Contour SETM as porous acetalized PVA
particles (id. ¶ 55); i.e., a polymer comprising vinyl alcohol monomers as
recited in the claims. The fast releasing microspheres of the Specification’s
example thus correspond to the “second group” of particles recited in the
claims: those that do not comprise functional groups having a charge.
The slow releasing microspheres in the Specification’s example were
“produced by introducing ionic group substituted polymers, specifically,
poly(sodium styrene-4-sulfonate) . . . and poly(vinyl sulfonic acid, sodium
salt) . . . into the CSE microspheres by radiation grafting.” Id. ¶ 104. The
modified microspheres were then exposed to a solution of doxorubicin HCl.
Id. The slow releasing microspheres thus correspond to the “first group” of
Appeal 2019-005006
Application 12/341,433

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particles recited in the claims: those that comprise a polymer comprising
vinyl alcohol monomers and a covalently bound charged polymer
comprising -SO3– groups.
The Specification states that, “under in vitro drug release conditions,
i.e. . . . in phosphate buffered saline (PBS) with Tween® 20 (polysorbate 20)
surfactant (pH 7.4, 0.05% wt/vol polysorbate 20),” the fast releasing
microspheres released “85–95% of the loaded drug . . . in 2 hrs.” Id. By
contrast, the slow releasing microspheres “display[ed] a very controlled,
slow and uniform release of the doxorubicin, i.e. only 5% of doxorubicin is
released in 2 hrs and only 10% is released in 24 hrs.” Id.
The release characteristics described in the Specification for the fast
releasing and slow releasing particles of the working example are the same
as those recited in claim 35. In addition, Figure 1 of the Specification is a
graph of the results of the working example that shows that the fast releasing
particles (“Lyophilized CSE”) released greater than 90% of the doxorubicin
after 12 hours, while slow releasing particles (“Prototype-1” and “Prototype-
2”) released less than 10% after 12 hours. The results shown therefore
correspond to the release characteristics recited in claim 33, as well.
Thus, as Appellant points out, the limitations of claims 33–35 are
tailored to the working example in the Specification. While the claims are
not limited to the exact polymers used in the example, the Examiner has not
persuasively shown that a skilled artisan would not have recognized that
Appellant was in possession of the claimed invention based on the
description, including the working example, provided in the Specification.
We therefore reverse the rejection of claims 33–35 under 35 U.S.C. § 112,
first paragraph, for lack of adequate written description.
Appeal 2019-005006
Application 12/341,433

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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
33–35 112, first
paragraph
Written Description 33–35

REVERSED