Ex Parte Battaglia

Patent Trials and Appeals Board

May 28, 2019

12991349 - (D) (P.T.A.B. May. 28, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/991,349 01/28/2011
23373 7590 05/30/2019
SUGHRUE MION, PLLC
2100 PENNSYLVANIA A VENUE, N.W.
SUITE 800
WASHINGTON, DC 20037
FIRST NAMED INVENTOR
Giuseppe Battaglia
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.
Ql21574 8031
EXAMINER
WHEELER, THURMAN MICHAEL
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
05/30/2019 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):
PPROCESSING@SUGHRUE.COM
sughrue@sughrue.com
USPTO@sughrue.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GIUSEPPE BATT AG LIA 1
Appeal2017-010393
Application 12/991,349
Technology Center 1600
Before ERIC B. GRIMES, FRANCISCO C. PRATS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method of treatment, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
Claims 1-3, 5, and 11-17 are on appeal. Claim 1 is the only
independent claim and reads as follows (emphasis added):
1. A method of treatment comprising administering
to a human or animal body a composition comprising
nanovesicles and, encapsulated within the aqueous core of the
1 Appellant identifies the Real Party in Interest as Biocompatibles UK
Limited. Appeal Br. 2.
Appeal2017-010393
Application 12/991,349
nanovesicles, a chemical agent, wherein the chemical agent is
delivered trans- and/or intra-epithelially to a human or animal
body across an epidermis, oral mucosa, buccal cavity or by
bronchial delivery, wherein the nanovesicles comprise an
amphiphilic block copolymer having a hydrophilic and a
hydrophobic block, the hydrophobic block comprises pendant
tertiary amine groups which have a pKa in the range 3.0 to 6.9,
the hydrophilic block is formed from ethylenically unsaturated
radically polymerisable monomers comprising a zwitterionic
monomer, the ratio of the degree of polymerization of the
hydrophilic to hydrophobic block is in the range of 1 :2.5 to 1 :8
and the nanovesicles have a diameter in the range 50-lOOOnm,
and wherein the chemical agent is delivered into the cell cytosol
after the nanovesicles have at least partially crossed the
epithelium, wherein the nanovesicles comprise two populations
of vesicles, the first of which has a hydrophilic block which is
polyalkylene oxide, and the second of which has a hydrophilic
block formed from ethylenically unsaturated radically
polymerizable monomers comprising a zwitterionic monomer,
and wherein the zwitterionic monomer has the general formula.
YBX I
in which Y is an ethylenically unsaturated group selected
from H2C=CR-CO-A-, H2C=CR-C6H4-A1-, H2C=CR-CH2A2,
R20-CO-CR =CR-C0-0 RCH =CH-C0-0-, '
RCH =C(COOR2)CH2-CO-O,
R)-{_
F!~r,
0
A is -0- or NR1;
A1 is selected from a bond, (CH2)1A2 and (CH2)1S03- in
which 1 is 1 to 12;
A2 is selected from a bond, -0-, 0-CO-, C0-0, CO-NR1-,
-NR1-CO O-CO-NR1- NR1-CO-O-
' ' '
R is hydrogen or Ci-4 alkyl;
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Appeal2017-010393
Application 12/991,349
R 1 is hydrogen, Ci-4 alkyl or BX;
R2 is hydrogen or Ci-4 alkyl;
B is a bond, or a straight branched alkanediyl, alkylene
oxaalkylene, or alkylene ( oligooxalkylene) group, optionally
containing one or more fluorine substituents;
X is a zwitterionic group.
DISCUSSION
The Examiner has rejected all of the claims on appeal under 35 U.S.C.
§ I03(a) as obvious based on Du,2 Lomas, 3 Discher,4 and Vamvakaki. 5 Final
Action6 2-3. The Examiner finds that "Du teaches pH-sensitive vesicles
based on a biocompatible zwitterionic diblock copolymer"; specifically,
PMPC-b-PDPA. Id. at 3. "Moreover, Du teaches that these nanovesicles
have biomedical applications as nanosized delivery vehicles," and can be
"used to encapsulate a chemical agent e.g., doxorubicin." Id. at 4. However,
the Examiner acknowledges that Du does not teach, among other things,
"that the chemical agent encapsulated within the aqueous core of the
nanovesicles is delivered trans- and/or intra-epithelially to a human or
2 Jianzhong Du et al., pH-Sensitive Vesicles Based on a Biocompatible
Zwitterionic Diblock Copolymer, 127(51) J. Am. Chem. Soc'y 17982-83
(2005).
3 Hannah Lomas et al., Biomimetic pH Sensitive Polymersomes for Efficient
DNA Encapsulation and Delivery, 19 Adv. Mat. 4238--43 (2007).
4Discher et al., US 2005/0003016 Al, Jan. 6, 2005.
5 M. Vamvakaki et al., Synthesis of Controlled Structure Water-Soluble
Diblock Copolymers via Oxyanionic Polymerization, 32 Macromolecules
2088-90 (1999).
6 Office Action mailed Feb. 1, 2016.
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Appeal2017-010393
Application 12/991,349
animal body across an epidermis, oral mucosa, buccal cavity or by bronchial
deliver[y ]." Id. at 5.
The Examiner finds that "Lomas teaches biomimetic pH sensitive
polymersomes for efficient DNA Encapsulation and Delivery," id., and
"teaches a method of using PMPC-PDPA polymersomes to deliver DNA
into the cellular cystosol [sic] of Chinese Hamster Ovary (CHO) cells (i.e.
epithelial-like cells)." Id. at 6. The Examiner also finds that "Discher teaches
polymersomes comprising polyethylene oxide[]-based diblock copolymers
for controlled transport and delivery of encapsulatable active agents." Id.
"Particularly, Discher teaches polymersomes for the delivery of a chemical
agent, e.g., doxorubicin (DOX), via the degradable polymersomes in MDA-
MB231 breast cancer epithelial cells, wherein there is nuclear and
perinuclear localization of DOX." Id.
The Examiner concludes that
it would have been apparent to one of ordinary skill in the art at
the time of the invention that polymersomes can be used to
deliver a chemical trans- and/or intra-epithelially to a human or
animal body across an epidermis and wherein the chemical
agent is delivered into the cell cytosol after the nanovesicles,
i.e., polymersomes, have at least partially crossed the
epithelium having a reasonable expectation of success by
following the teachings of Du, Lomas and Discher, as a whole.
Id. at 6-7.
Appellant argues that "the Examiner has acknowledged that Du does
not disclose or suggest delivery of the chemical agent across an epidermis,
oral mucosa, buccal cavity or by bronchial delivery." Appeal Br. 9.
Appellant argues that "Lomas cannot disclose or suggest delivery across an
epidermis, oral mucosa, buccal cavity or by bronchial delivery because the
epidermal layer in Lomas is removed and discarded." Id. at 10.
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Appeal2017-010393
Application 12/991,349
Appellant also argues that "the only disclosure in Discher cited in the
Office Action relates to the incubation of doxorubicin with breast cancer
epithelial cells, yet is completely silent regarding delivery across an
epidermis, oral mucosa, buccal cavity or by bronchial delivery." Id. at 11.
Finally, Appellant argues that "Vamvakaki is completely silent regarding
any delivery method recited in the present claims," and concludes that "no
cited document discloses or suggests the presently recited delivery of a
chemical agent across an epidermis, oral mucosa, buccal cavity or by
bronchial delivery. The rejection should therefore be reversed at least on this
ground." Id. at 12.
We agree with Appellant that the Examiner has not provided a
sufficient evidentiary basis for concluding that the route of delivery recited
in claim 1 would have been obvious to a person of ordinary skill in the art
based on the cited references. "[T]he examiner bears the initial burden, on
review of the prior art or on any other ground, of presenting a prima facie
case ofunpatentability." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir.
1992). "[R ]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,418 (2007)
(quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). "[P]atentability is
determined on the totality of the record, by a preponderance of evidence
with due consideration to persuasiveness of argument." In re Oetiker, 977
F.2d at 1445.
Here, the Examiner has acknowledged that Du does not teach delivery
of a chemical agent "trans- and/or intra-epithelially to a human or animal
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Appeal2017-010393
Application 12/991,349
body across an epidermis, oral mucosa, buccal cavity or by bronchial
deliver[y ]," Final Action 5, but relies on Lomas and Discher to make up for
this deficiency in Du. Id. at 5---6. We do not agree that Lomas or Discher
disclose or suggest the disputed limitation.
Lomas discloses biomimetic pH-sensitive polymersomes for
delivering DNA. (Lomas, title). However, Lomas focuses on the activity of
the polymersomes at the cellular level. See, e.g., id. at 4240, last paragraph
( discussing endocytosis of polymersomes by cells and the effect of the
resulting pH change on the polymersomes ). The Examiner points to Lomas'
disclosure of delivering GFP-encoding DNA to Chinese Hamster Ovary
(CHO) cells using polymersomes (Final Action 6; Lomas 4241 ), but the
cited experiment was carried out in vitro, not in vivo. Lomas 4243, left col.
That is, the CHO cells were cultured (id. at 4242--4243 ("Cell Culture")) and
then transfected with GFP-encoding plasmids (id. at 4243, left col.
("Epifluorescence Microscopy and Transfection") and 4242, right col.
("GFP Plasmid Preparation")).
Discher discloses "polyethylene oxide (PEO)-based polymersome
vesicles ... and methods of use therefor for the controlled transport and
delivery of encapsulatable active agents contained therein." Discher,
abstract. Discher states that its
invention provides methods of using the polymersome or
encapsulating membrane to transport one or more of the above
identified compositions to or from a patient in need of such
transport activity. For example, the polymersome could be used
to deliver a drug or therapeutic composition to a patient's tissue
or blood stream, or it could be used to remove a toxic
composition from the blood stream of a patient.
Id. ,I 22.
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Application 12/991,349
The Examiner points to Discher' s disclosure of delivering doxorubicin
(DOX) to MDA-MB231 breast cancer epithelial cells. Final Action 4.
Discher discloses that "DOX-loaded degradable polymersomes ... were
incubated ... with MDA-MB231 (human breast cancer epithelial cells), and
showed uptake within hours by passive endocytosis." Discher ,r 274.
Thus, like Lomas, Discher specifically describes only in vitro, not in
vivo, delivery of an active agent to cells. Although Discher suggests using
its polymersomes to deliver a drug to a patient, id. ,r 22, even that suggestion
is only to "deliver a drug or therapeutic composition to a patient's tissue or
blood stream." Id., emphasis added. The Examiner has not pointed to any
suggestion, in Discher or Lomas, of delivering a chemical agent "trans-
and/ or intra-epithelially to a human or animal body across an epidermis, oral
mucosa, buccal cavity or by bronchial delivery," as required by claim 1. The
Examiner does not point to anything in V amvakaki that would make up for
the deficiency of the other references.
We therefore conclude that the Examiner has not shown by a
preponderance of the evidence that the method of claim 1, including the
recited route of delivery, would have been obvious to a person of ordinary
skill in the art based on Du, Lomas, Discher, and Vamvakaki.
In response to Appellant's argument on this point, the Examiner again
cites the same disclosures of the references that were cited in the Final
Action. See Ans. 3--4. For the reasons discussed above, we do not agree that
a preponderance of the evidence supports a conclusion of obviousness, based
on the cited references.
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Application 12/991,349
SUMMARY
We reverse the rejection of claims 1-3, 5, and 11-17 under 35 U.S.C.
§ 103(a) based on Du, Lomas, Discher, and Vamvakaki.
REVERSED
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