Ex Parte Cao et al

Patent Trial and Appeal Board

Feb 9, 2018

13641590 (P.T.A.B. Feb. 9, 2018)

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.
13/641,590 10/16/2012 Yunwei Charles Cao 222106-1555 1085
24504 7590 02/13/2018
THOMAS I HORSTEMEYER, LLP
3200 WINDY HILL ROAD, SE
SUITE 1600E
ATLANTA, GA 30339
EXAMINER
HUMPHREY, LOUISE WANG ZHIYING
ART UNIT PAPER NUMBER
1657
NOTIFICATION DATE DELIVERY MODE
02/13/2018 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
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte YUNWEI CHARLES CAO, CHEN LIU, HONGYAN LIU,
ZHONGLIANG WANG, and SOON HYE YANG
Appeal 2016-007263
Application 13/641,5901
Technology Center 1600
Before FRANCISCO C. PRATS, JOHN G. NEW, and RYAN H. FLAX,
Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a
nanoparticle that has, attached to it, an enzyme and a moiety that recognizes
a molecular target. The Examiner rejected the claims for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
1 Appellants state that the “real party in interest of the instant application is
University of Florida Research Foundation, Inc. having a principle place of
business at 223 Grinter Hall, Gainesville, Florida 32611.” Appeal Br. 3.
Appeal 2016-007263
Application 13/641,590
STATEMENT OF THE CASE
The following rejections are before us for review:
(1) Claims 1-3, 5-9, 12-15, and 17, under 35 U.S.C. § 103(a) as
being unpatentable over Farokhzad2 (Final Act. 2-6, 9-10);
(2) Claim 4, under 35 U.S.C. § 103(a) as being unpatentable over
Farokhzad and Suri3 (id. at 6-7);
(3) Claim 10, under 35 U.S.C. § 103(a) as being unpatentable over
Farokhzad and Griinweller4 (id. at 7-8);
(4) Claim 11, under 35 U.S.C. § 103(a) as being unpatentable over
Farokhzad, Griinweller, and Suri (id. at 8-9); and
(5) Claim 16, under 35 U.S.C. § 103(a) as being unpatentable over
Farokhzad and Fi5 (id. at 10-11).
Claim 1, the only independent claim on appeal, reads as follows:
1. A nanozyme, comprising:
a nanoparticle having an enzyme and a plurality of
recognition moieties attached thereto, and optionally having
one or more protecting moieties attached thereto,
2 WO 2008/105773 A2 (published Sept. 4, 2008).
3 S. Suri et al., RNase: A Novel Enzyme For Treatment Of Cancers, 5 The
Internet Journal of Oncology 1-7 (2007).
(http://ispub.eom/IJO/5/l/5326 (last accessed Sept. 17, 2014)).
4 Arnold Griinweller & Roland K. Hartmann, Locked Nucleic Acid
Oligonucleotides: The Next Generation of Antisense Agents?, 21 Biodrugs
235^13 (2007).
5 Chun-Qi Fi & Guang-Xian Zhang, Nanosize delivery as an emerging
platform for cancer therapy, 7 Cancer Biology & Therapy 1860-62
(2008).
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Appeal 2016-007263
Application 13/641,590
wherein the recognition moieties target a specific target
molecule that reacts with the enzyme, and
wherein the recognition moieties and protecting moieties
are at a density on the nanoparticle that substantially reduces
non-target molecules from reacting with the enzyme.
Appeal Br. 18 (emphasis added).
DISCUSSION
The Examiner’s Prima Facie Case
The Examiner found that Farokhzad teaches a nanoparticle for
targeted delivery of therapeutic agents, the nanoparticle having attached to it
both the recognition moieties and enzyme required by Appellants’ claim 1.
Final Action 3. Specifically, the Examiner cited Farokhzad as disclosing
that its nanoparticle includes “a targeting moiety (recognition moiety) such
as an antibody and a therapeutic agent such as an enzyme.” Id. (citing
Farokhzad 20, 24, 237, and claim 60).
As to the enzyme required by Appellants’ claim 1, the Examiner
found that “Farokhzad teaches that the agent to be delivered could be an
enzyme (F-asparaginase, which performs a hydrolysis), which would react
with the targeting molecule (proteins in cells or specifically, asparagine an
amino acid in proteins in cells).” Id. (citing Farokhzad 237 and 175).
Although the Examiner found that Farokhzad differs from Appellants’
claim 1 in not expressly describing its nanoparticles as having recognition
and protecting moieties that meet claim l’s density requirement, the
Examiner concluded, nonetheless, that nanoparticles meeting that
requirement would have been obvious. Id. at 3—4.
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Appeal 2016-007263
Application 13/641,590
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a prima
facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant in
response, patentability is determined on the totality of the record,
by a preponderance of evidence with due consideration to
persuasiveness of argument.
In the present appeal, we agree with Appellants that the Examiner has
not shown by a preponderance of the evidence that the nanozyme recited in
claim 1 would have been obvious to an ordinary artisan.
In particular, we agree with Appellants that Farokhzad “does not teach
or suggest a targeting moiety that targets asparagine, the ‘specific molecule
that also reacts with the enzyme’ (L-asparagine) as required by instant claim
1.” Appeal Br. 10.
We acknowledge, as the Examiner found, that Farokhzad teaches a
“targeted particle” which may be a nanoparticle, and which includes a
therapeutic agent and a “targeting moiety,” the targeting moiety “targeting]
prostate cancer cells.” Farokhzad, p. 102 (claims 1 and 2).
We acknowledge, as the Examiner found, that Farokhzad discloses
that “[i]n some embodiments, the agent to be delivered may be an anti­
cancer agent. Exemplary protein anti-cancer agents are enzymes (e.g.[,] L-
asparaginase). . . .” Id. ^ 237.
As Appellants point out, however, claim 1 requires its recognition
moieties to “target a specific target molecule that reacts with the enzyme.”
Appeal Br. 18 (emphasis added). As Appellants contend, the Examiner does
not identify in Farokhzad any teaching or suggestion of a targeting moiety
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Appeal 2016-007263
Application 13/641,590
that targets asparagine, which is undisputedly the specific molecule that
reacts with the asparaginase enzyme.
In that regard, the Examiner contends that “Farokhzad specifically
suggests that the target of the targeting molecule can comprise protein, a
carbohydrate, a lipid, and/or a nucleic acid (see para. 00175), therefore
implying that the target being a molecule in which the agent reacts with.”
Ans. 5.
We acknowledge Farokhzad’s teaching that its targeting moieties may
target “a protein, a carbohydrate, a lipid, and/or a nucleic acid. In certain
embodiments, a target can comprise a protein and/or characteristic portion
thereof, such as a tumor-marker, integrin, cell surface receptor,
transmembrane protein, intercellular protein, ion channel, membrane
transporter protein, enzyme, antibody, chimeric protein, glycoprotein, etc.”
Farokhzad]} 175.
The Examiner, however, does not identify any disclosure in
Farokhzad that teaches, suggests, or even implies, that its targeting moieties
target asparagine, the specific molecule that reacts with the enzyme
identified by the Examiner as teaching the enzyme element recited by
Appellants’ claim 1. Nor does the Examiner otherwise adequately explain
why any other teaching in Farokhzad would suggest or imply that its
targeting moiety targets a specific molecule that also reacts with an enzyme
delivered by the nanoparticle. As noted above, for example, in claim 1 of
Farokhzad cited by the Examiner, the targeting moiety targets prostate
cancer cells (Farokhzad, p. 102), rather than a specific molecule with which
a nanoparticle-delivered enzyme would react; contrary to statements by the
Examiner, a cell is not a molecule (Answer 6).
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Appeal 2016-007263
Application 13/641,590
In sum, for the reasons discussed, Appellants persuade us that the
Examiner has not shown by a preponderance of the evidence that the
nanozyme recited in Appellants’ claim 1 would have been obvious to an
ordinary artisan. We, therefore, reverse the Examiner’s rejection of claim 1,
and its dependent claims 2, 3, 5-9, 12-15, and 17, over Farokhzad.
As to the remaining rejections, the Examiner cited Suri, Griinweller,
and Li as evidence that the additional elements recited in dependent claims
4, 10, 11, and 16 would have been obvious features of the nanozyme recited
in Appellants’ claim 1. Because the Examiner does not adequately explain
how Suri, Griinweller, and/or Li remedy Farokhzad’s deficiencies, discussed
above, as to claim 1, we reverse the Examiner’s rejections based on
Farokhzad combined with Suri, Griinweller, and Li.
REVERSED
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