Ex Parte Bode et al

Patent Trials and Appeals Board

Jun 3, 2019

14357860 - (D) (P.T.A.B. Jun. 3, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/357,860 05/13/2014
110382 7590 06/05/2019
VIKSNINS HARRIS P ADYS MALEN LLP
7851 Metro Parkway
Suite 325
Bloomington, MN 55425
FIRST NAMED INVENTOR
AnnM. Bode
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.
0953 l.328US 1 2498
EXAMINER
WANG, SHENGTIJN
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
06/05/2019 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):
docketing@vhpmlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANN M. BODE, YOUNG-YEON CHO, ZIGANG DONG, and
DONG JOON KIM
Appeal2019-000536
Application 14/357,860
Technology Center 1600
Before DEBORAH KATZ, ULRIKE W. JENKS, and JOHN G. NEW,
Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
Appellants1 submit this appeal2 under 35 U.S.C. § 134(a) involving
claims to a method of treating cancer with herbacetin (3,5,7,8,4' -
pentahydroxyflavone). Examiner rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
1 Appellants identify the Real Party in Interest as the Regents of the
University of Minnesota. App. Br. 2.
2 We have considered and herein refer to the Specification of May 13, 2014
("Spec."); Final Office Action of August 22, 2017 ("Final Act."); Appeal
Brief of February 20, 2018 ("App. Br."); Examiner's Answer of August 8,
2018 ("Ans."); and Reply Brief of October 8, 2018 ("Reply Br.").
Appeal2019-000536
Application 14/357,860
STATEMENT OF THE CASE
"Elevated omithine decarboxylase (ODC) activity is observed in
neoplastic tissues suggesting that this enzyme is a target for cancer
prevention or treatment." Spec. 1:13-15. "There is[ ... ] a need for anti-
cancer agents that have specificity for ODC and have improved
pharmacologic properties such as reduced toxicity." Id. I: 19-20. The
Specification discloses that herbacetin (3,5,7,8,4'-pentahydroxyflavone) "can
1) bind to omithine decarboxylase (ODC); 2) inhibit [O-
tetradecanoylphorbol-13-acetate]-induced ODCl activity; 3) suppress
promoter activities of activator protein-I, Cox2, NF-kappaB; [and] 4)
decrease cell proliferation and anchorage independent colony formation of
JB6 mouse epidermal skin cells." Id. 18: 21-27.
Claims 1-5 and 10-13 are on appeal, and can be found in the Claims
Appendix of the Appeal Brief. Independent claim 1 is reproduced below:
1. A method for inactivating omithine decarboxylase (ODC)
in a cell comprising contacting the cell in vitro or in vivo with an
effective amount of 3,5,7,8,4'-Pentahydroxyflavone, or a
pharmaceutically acceptable salt thereof.
App. Br. 14 (Claims Appendix). The other independent claims, claims 2, 3,
and 12 similarly recite methods using 3,5,7,8,4'-Pentahydroxyflavone.
Appellants request review of Examiner's rejection of claims under 35
U.S.C. § 103(a) over Amin3 and Brown.4
3 Amin et al., US 7,803,902 B2, issued September 28, 2010 ("Amin").
4 N. Brown and E. Jacoby, On Scaffolds and Hopping in Medicinal
Chemistry, 6 MINI-REVIEWS IN MED. CHEM. 1217-1229 (2006) ("Brown").
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Appeal2019-000536
Application 14/357,860
Obviousness over Amin and Brown
Examiner found that Amin teaches a personal care composition used
as a sunscreen that can prevent skin cancer and may contain taxifolin
(3,3',4',5,7-pentahydroxyflavanone) or dihydrorobinetin (3,3',4',5',7-
pentahydroxyflavanone ). Ans. 4. Examiner acknowledges that "Amin does
not expressly [teach] the compound of the instant invention." Id. at 5.
Examiner relies on Brown for modifying Amin' s
pentahydroxyflavanone compounds by "scaffold hopping, or moving the
substituents around a scaffold molecule of interest ... to optimize the
pharmacological properties of a particular parent compound." Ans. 7.
Examiner found that "[ o ]ne of ordinary skill in the art would have been
motivated to do this because Amin teaches a scaffold compound of the
instant [compound], that of 3,3',4',5',7-pentahydroxyflavone, to be a skin
cancer preventative, in an embodiment of a topical composition that is used
as sun screen." Id. Examiner concludes that "a person of ordinary skill,
would understand from the teaching of Amin, that 3,3',4',5',7-pentahydroxy
flavanone can be rendered to the instant compound, by the application of
such scaffold hopping, wherein the hydroxyl moieties can be moved to
different points on the three rings ... to successfully treat cancer." Id. at 8.
The dispositive issue on appeal is whether the preponderance of
evidence of record supports Examiner's conclusion that the combination of
references renders obvious using 3,5,7,8,4'-pentahydroxyflavone as an anti-
cancer agent.
Principles of Law
[T]he examiner bears the initial burden, on review of the prior art
or on any other ground, of presenting a prima facie case of
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Application 14/357,860
unpatentability. If that burden is met, the burden of coming
forward with evidence or argument shifts to the applicant. 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 re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Analysis
Appellants contend that Amin "describe[ s] modified Bowman Birk
Protease Inhibitor proteins (BBPis) ... used to treat a myriad of conditions
from, e.g., hair loss to tick bites to cancer, depending on the modified BBPI
selected." App. Br. 8. Appellants contend that Amin lists dihydrorobinetin
and taxifolin as possible additional active ingredients, but does not teach or
suggest any activity of the compounds, particularly anti-cancer activity. See
id. at 9. Appellants contend that one of ordinary skill in the art "would have
no motivation to select either of these secondary compounds ... ,
particularly given that 1) the focus of [Amin] is modified BBPis; 2) no
activity information is provided for either dihydrorobinetin or taxifolin; and
3) no compositions were made using these two agents." Id.
We find that Appellants' have the better position. Amin teaches a
"personal care composition comprising a modified variant TGF-BBPI [] for
use in improving the appearance and/or condition of the skin of a subject
suffering from skin cancer." Amin 78:7-10. Amin' s personal care
composition may "further comprise at least one active ingredient in addition
to the [BBPI proteins] provide[d] herein." Id. at 87:20-25; 12:6-15 ("the
term 'scaffold' refers to a BBPI protein sequence ... "). Among additional
active ingredients for personal care compositions, Amin teaches antioxidants
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Application 14/357,860
and plant extracts, such as catechins, polyphenols, and flavones, e.g.,
kaempferol and quercetin. See id. at 88:49-90:60. Amin teaches "[i]n yet
some additional embodiments, the personal care compositions of the present
invention comprise at least one ... dihydrorobinetin (3,3',4',5',7-
pentahydroxyflavanone) [or] taxifolin (3,3',4',5,7- pentahydroxyflavanone )."
Id. at 92: 64-93: 1. As Appellants point out, Amin teaches BBPI proteins
may be used for improving skin suffering from skin cancer; not the
secondary active ingredients listed, e.g., pentahydroxyflavanones.
Furthermore, Amin does not distinguish among the many secondary active
ingredients listed. As such, there is no reason in Amin that would suggest
choosing either of the two pentahydroxyflavanones as compounds that
would be useful in treating cancer, or as a starting point for further
modification. Accordingly, we agree with Appellants' contention that
Examiner has not provided a reason to first select and then modify
dihydrorobinetin or taxifolin in order to arrive at using 3,5,7,8,4'-
Pentahydroxyflavone as an anti-cancer compound. To establish
obviousness, the Examiner must identify some reason that would have led a
chemist to modify a known compound. Takeda Chem. Indus., Ltd. v.
Alphapharm Pty., Ltd., 492 F.3d 1350, 1357 (Fed. Cir. 2007).
With respect to Examiner's proposed modifications to the compounds,
Appellants contend that Brown "provide[s] no specific guidance as to how
one skill in the art would proceed with modifying these compounds should
they actually be selected." App. Br. 9. Appellants further contend that "to
generate the instantly claimed 3,5,7,8,4'-pentahydroxyflavone from the cited
compounds, one skill in the art would not only need to both remove polar
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Application 14/357,860
hydroxyl group(s) from the Bring and add polar hydroxyl group(s) to the A
ring, but would also need to add a double bond to the Cring." Id. at 10.
We find that Appellants' position is supported by the evidence.
Although we agree with Examiner that herbacetin, dihydrorobinetin, and
taxifolin are structurally similar compounds, showing structural similarity
alone does not end the obviousness inquiry. Rather, Examiner must show
that the prior art would have suggested making the specific molecular
modifications necessary to achieve the claimed invention. Brown teaches
"[ s Jcaffold hopping has quickly become a very important area of
investigation in drug discovery to determine or design novel molecular
backbones that still permit the desired response to be observed when the
backbone is decorated with substituents to evoke that function." Brown
1220. Brown does not describe any specific molecular modifications for
flavones, in particular the numerous modifications necessary to obtain
3,5,7,8,4'-pentahydroxyflavone. See Takeda, 492 F.3d at 1361 ("As for
ring-walking, the court found that there was no reasonable expectation in the
art that changing the positions of a substituent on a pyridyl ring would result
in beneficial changes"). We therefore find that Examiner has not provided a
sufficiently articulated rationale in order to arrive at a conclusion of
obviousness, and thereby, has not met the burden of presenting a prima facie
case. See Oetiker, 977 F.2d at 1445.
We conclude that the preponderance of the evidence of record does
not support Examiner's conclusion that the combination of Amin and Brown
teaches a method of contacting a cell with, or administering, 3,5,7,8,4'-
pentahydroxyflavone having all the limitations of independent claims 1, 2,
and 3. Likewise, we conclude that the preponderance of the evidence of
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Application 14/357,860
record does not support Examiner's conclusion that the prior art combination
teaches a dermal product comprising 3,5,7,8,4'-pentahydroxyflavone having
all of the limitations of independent claim 12. Therefore, we reverse the
rejection under 35 U.S.C. § 103(a) that relies on the underlying teachings of
Amin and Brown.
SUMMARY
We reverse the obviousness rejection of claims 1-5 and 10-13 under
35 U.S.C. § 103(a) as unpatentable over Amin and Brown.
REVERSED
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