The Research Foundation for the State University of New York

Patent Trials and Appeals Board

Dec 24, 2021

2021001880 (P.T.A.B. Dec. 24, 2021)

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.
13/972,539 08/21/2013 Juntao Luo 1892-110US01 6146
169515 7590 12/24/2021
The Research Foundation for SUNY
P.O. Box 9
Albany, NY 12201-0009
EXAMINER
KASSA, TIGABU
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
12/24/2021 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):
ashtonka@rfsuny.org
ben.clark@rfsuny.org
patents@rfsuny.org
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JUNTAO LUO, WENZHE HUANG,
YU SHAO, and CHANGYING SHI1

Appeal 2021-001880
Application 13/972,539
Technology Center 1600
Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
JOHN E. SCHNEIDER, 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
compound, which have been rejected as obvious. We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE.

1 Appellant identifies the real party in interest as The Research Foundation
for the State University of New York. Appeal Br. 2. “Appellant” refers to
“applicant” as defined in 37 C.F.R. § 1.42.
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Application 13/972,539

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STATEMENT OF THE CASE
Appellant’s “disclosure provides . . . functional segregated
telodendrimers having, for example, two or three functional segments.”
Spec. ¶ 4. “‘[T]elodendrimer’ refers to a linear-dendritic copolymer,
containing an optional hydrophilic segment (i.e., PEG moiety) and one or
more chemical moieties covalently bonded to one or more end groups of the
dendron.” Id. ¶ 51. The Specification also “provides nanocarriers comprising
the telodendrimers. In an embodiment, a composition comprises an aggregate
of a plurality of the telodendrimers that form a nanocarrier having a
hydrophobic core and a hydrophilic exterior.” Id. ¶ 9.
Claims 1–5, 16, 18–25, and 27 are on appeal. Claim 1, the only
independent claim, is reproduced in Appellant’s Claims Appendix. Appeal
Br. 19–20. In response to an election-of-species requirement, Appellant
elected the following chemical species encompassed by generic claim 1:

Response to Election of Species Requirement, filed July 13, 2015, page 8.
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The Examiner states that “Appellant[] received examination on the
merits specifically with respect to the elected species as set forth above not
to the broader claim scope recited in claim 1.” Ans. 4. “[T]he Examiner
addresses Appellant’s argument[] to the extent in which it applies to the
elected species only.” Id.
Appellant argues that the Examiner erred in taking this position,
because “[c]laim 1 includes a genus and is not limited to the species
highlighted by the Examiner.” Reply Br. 2–3.
This argument misunderstands the effect of an election-of-species
requirement. “When examining a Markush claim, the examiner may generally
choose to require a provisional election of species. . . . The applicant’s
election serves as a starting point for the search and examination of the
claim.” MPEP § 803.02(I). “If the elected species . . . is anticipated by or
obvious over the prior art, an appropriate art-based rejection of any claim that
reads on the elected species . . . should be made.” MPEP § 803.02(III)(C)(1).
If the elected species . . . is not anticipated by or obvious over
the prior art, the examiner should extend the search and
examination to a non-elected species . . . that falls within the
scope of a proper Markush grouping that includes the elected
species. The search and examination should be continued until
either (1) prior art is found that anticipates or renders obvious a
species that falls within the scope of a proper Markush
grouping that includes the elected species, or (2) it is
determined that no prior art rejection of any species that falls
within the scope of a proper Markush grouping that includes the
elected species can be made.
MPEP § 803.02(III)(C)(2).
In this case, the Examiner has made clear that the search and
examination of claim 1’s genus of compounds has not been extended beyond
the single elected species. Thus, the issue on appeal is whether the Examiner
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Application 13/972,539

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has properly rejected that single species. We take no position respecting the
patentability of other species or the genus encompassed by Appellant’s
claims. See Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BPAI 1987).
OPINION
Claims 1–5, 16, 18–25, and 27 stand rejected under 35 U.S.C. § 103
as obvious based on Lam2 and Tomic-Vatic.3 Final Action4 3. The Examiner
finds that Lam’s paragraph 160, claims 1–25, and “Figures 1–6, 26–32, 41,
48B, 49B, and 50–52B” show “dendrimers that meet the scope of instant
claim 1.” Id. at 3–6.
More specifically, the Examiner notes that in “Appellant’s elected
species depicted above R1 is cholic acid moiety and R2 is vitamin E moiety.”
Ans. 5–6. The Examiner points to Lam’s Figure 51, finding that “[t]he
difference between Appellant’s elected species and for instance the structure
depicted in figure 51 is in figure 51 both R1 and R2 are cholic acid.” Id. at 6.
See also Final Action 7 (“Lam et al. does not specifically teach vitamin E
from the elected species structure attached within the dendrimer.”).
The Examiner concludes, however, that it would have been obvious
“to modify the teachings of Lam et al. by attaching vitamin E or analogues
in the dendrimer structure because Tomic-Vatic teach Vitamin E (VE)
analogues, epitomized by a-tocopheryl succinate (a-TOS), are proapoptotic

2 Lam et al., US 2011/0286915 A1, pub. Nov. 24, 2011.
3 Tomic-Vatic et al., Vitamin E amides, a new class of vitamin E analogues
with enhanced proapoptotic activity, International Journal of Cancer
117:188–193 (2005).
4 Office Action mailed July 30, 2019.
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agents with selective antineoplastic activity.” Final Action 8 (emphasis
omitted).
Appellant argues that “in instant claim 1, R1 and R2 are on separate
dendritic points, which may contain one or more branching units, resulting
in R1 and R2 groups that are on different segments of the compound. . . .
This feature is absent in Lam.” Appeal Br. 7. Appellant argues that “[c]laim
1 recites limitations not taught, suggested, or otherwise yielded by any
permissible review of the cited art. Initially, the Examiner has correctly
indicated Lam is deficient for not specifically teaching a Vitamin E moiety
either as R1 or R2 possibilities.” Reply Br. 5 (citing Ans. 8).
Appellant also argues that Tomic-Vatic “merely states the superiority
of the vitamin E amides over vitamin E esters in inducing apoptosis in
malignant cells” and the Examiner does not “provide any rationale
supporting a conclusion that one having ordinary skill in the art would be
motivated to conjugate vitamin E or vitamin E analogues to a nanocarrier of
Lam.” Appeal Br. 9.
We agree with Appellant that the Examiner has not adequately
supported a prima facie case of obviousness. “An examiner bears the initial
burden of presenting a prima facie case of obviousness.” In re Huai-Hung
Kao, 639 F.3d 1057, 1066 (Fed. Cir. 2011). “Obviousness requires more
than a mere showing that the prior art includes separate references covering
each separate limitation in a claim under examination.” Unigene Labs., Inc.
v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir. 2011). “Rather, obviousness
requires the additional showing that a person of ordinary skill at the time of
the invention would have selected and combined those prior art elements in
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the normal course of research and development to yield the claimed
invention.” Id.
The Examiner has made clear that the examination of Appellant’s
claims has been limited to the elected species. Ans. 4. With respect to that
species, the Examiner points to the compound of Lam’s Figure 51, and finds
that “[t]he difference between Appellant’s elected species and for instance
the structure depicted in figure 51 is in figure 51 both R1 and R2 are cholic
acid. Lam et al. do not explicitly or specifically teach as R2 vitamin E
moiety.” Ans. 6. Lam’s Figure 51 is reproduced below:

Figure 51 “shows the structure of HS-PEG5000-CA8.” Lam ¶ 62.
As we understand it, the basis for the rejection is that Tomic-Vatic
would have led a skilled artisan to substitute vitamin E moieties for four of
the eight cholic acid moieties in Lam’s Figure 51 compound, thus producing
Appellant’s elected species. We disagree.
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In addition, as Appellant has pointed out, in the elected species of
“instant claim 1, R1 and R2 are on separate dendritic points, which may
contain one or more branching units, resulting in R1 and R2 groups that are
on different segments of the compound. This feature is highlighted in figures
1, 2, 3, and 4 of the instant application. This feature is absent in Lam.”
Appeal Br. 7.
In addition, we agree with Appellant that the Examiner has not
persuasively explained how Tomic-Vatic would have made it obvious to
replace four of the cholic acid moieties of Lam’s HS-PEG5000-CA8 with
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Application 13/972,539

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vitamin E moieties. The Examiner cites Tomic-Vatic’s disclosure that
“[v]itamin E (VE) analogues, epitomized by [α]-tocopheryl succinate ([α]-
TOS), are proapoptotic agents with selective antineoplastic activity.” 5 Final
Action 7.
As best we understand it, the Examiner’s reasoning is that a skilled
artisan would have expected, based on Tomic-Vatic’s disclosure that vitamin
E analogues are proapoptotic agents with antineoplastic activity, that
modifying Lam’s HS-PEG5000-CA8 by replacing four of its eight cholic acid
moieties with vitamin E moieties would result in a modified HS-PEG5000-CA8
also having proapoptotic and antineoplastic activity.
The Examiner has not, however, provided evidence or sound technical
reasoning to show that a skilled artisan would have expected that modifying
Lam’s HS-PEG5000-CA8 to include vitamin E moieties would result in a
compound with proapoptotic or antineoplastic activity. Tomic-Vatic’s
teachings are limited to vitamin E analogues as separate compounds, not as
part of a larger structure like that of Lam’s HS-PEG5000-CA8. Lam describes
its invention as follows:
The present invention provides nanocarriers that have a
hydrophobic interior and a hydrophilic exterior permitting the
nanocarriers to deliver drugs having low water solubility. The
nanocarriers are formed by the aggregation of conjugates into
micelles. . . . The hydrophobic core of the nanocarriers can be
provided by cholic acid, which has a hydrophobic face and a
hydrophilic face. Typically, several cholic acid groups are used
to sequester the drug in the nanocarrier. The hydrophilicity of
the nanocarriers is provided by a polyethyleneglycol polymer

5 The remainder of the Tomic-Vatic abstract quoted by the Examiner
concerns analogues in which “the ester bond was replaced by an amide
bond,” which is not part of the elected species. Final Act. 7.
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chain that encapsulates the nanocarrier and forms a micelle
through the aggregation of the conjugates.
Lam ¶ 64. The Examiner has not explained what aspect of Lam’s HS-
PEG5000-CA8 would have led a skilled artisan to expect proapoptotic or
antineoplastic activity to result from incorporating vitamin E moieties.
Thus, the Examiner has not provided any persuasive reasoning,
supported by evidence, to establish that the teachings of Lam and Tomic-
Vatic would have suggested the elected species to a person of ordinary skill
in the art. “[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’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)
(quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)).
In summary, the Examiner’s rejection fails to persuasively show that a
skilled artisan would have been led to modify Lam based on Tomic-Vatic, or
that such a modification would have resulted in the elected species of claim 1.
We therefore reverse the rejection of claims 1–5, 16, 18–25, and 27 under
35 U.S.C. § 103 based on Lam and Tomic-Vatic.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–5, 16,
18–25, 27
103 Lam, Tomic-Vatic 1–5, 16,
18–25, 27
REVERSED