Ex Parte Kumar

Patent Trial and Appeal Board

Mar 14, 2017

13965158 (P.T.A.B. Mar. 14, 2017)

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.
13/965,158 08/12/2013 Praveen Kumar 105013-0251 6468
30542 7590 03/16/2017
FOT FY Rr T ARDNFR T T P
EXAMINER
3000 K STREET N.W. KISHORE, GOLLAMUDI S
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1612
NOTIFICATION DATE DELIVERY MODE
03/16/2017 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PRAVEEN KUMAR
Appeal 2015-001588
Application 13/965,158
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
RYAN H. FLAX, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL1
This appeal under 35 U.S.C. § 134(a) involves claims 1—3 and 5—13
(Final Act.2 2). Examiner entered rejections under 35 U.S.C. § 103(a). We
have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
STATEMENT OF THE CASE
Appellant’s “invention relates to biphasic lipid-vesicle compositions”
(Spec. 11). Each of Appellant’s independent claims 1, 9, and 10 require,
inter alia, multilamellar lipid vesicles that comprise 2,6-di-tert-butoxyphenol
1 Appellant identifies the real party in interest as “Helix Biopharma
Corporation” (App. Br. 2).
2 Examiner’s Final Office Action mailed Feb. 7, 2014.
Appeal 2015-001588
Application 13/965,158
in an amount to stabilize the lipid vesicles from oxidation (see App. Br. 15—
17). Claim 1 is representative and reproduced below:
1. A biphasic vesicle composition comprising:
(a) a first phase comprising an oil-in-water emulsion
which oil-in-water emulsion comprises oil in a water phase
wherein a sufficient amount of oil is employed to form a
composition suitable for topical application, and wherein the
water phase comprises interferon alpha-2b and a first
antioxidant which inhibits oxidation of the interferon alpha-2b;
and
(b) a second phase comprising multilamellar lipid
vesicles suspended in said first phase wherein said vesicles
contain entrapped therein a composition comprising an oil-in­
water emulsion wherein the water phase comprises interferon
alpha-2b and said first antioxidant,
wherein each phase contains [] a therapeutically effective
aggregate amount of said interferon alpha-2b for treating
cervical dysplasia, and
wherein the multilamellar lipid vesicles comprise a
second antioxidant to stabilize said lipid vesicles from
oxidation wherein said second antioxidant is 2,6-di-tert-
butoxyphenol.
(App. Br. 15.)
The claims stand rejected as follows:
Claims 1—3 and 5—13 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Foldvari,3 Anderson,4 and Song,5 with
or without Hellerbrand.6
3 Foldvari et al., US 6,656,499 Bl, issued Dec. 2, 2003.
4 Anderson, US 2010/0086573 Al, published Apr. 8, 2010.
5 Song, US 2005/0037048 Al, published Feb. 17, 2005.
6 Hellerbrand et al., US 2009/0285880 Al, published Nov. 19, 2009.
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Appeal 2015-001588
Application 13/965,158
Claims 1—3 and 5—13 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Foldvari, Anderson, and Park,7 with or
without Hellerbrand.
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion that the combination of Foldvari and Anderson, taken with
Song or Park, with or without Hellerbrand, makes obviousness a biphasic
vesicle composition comprising, inter alia, 2,6-di-tert-butoxyphenol?
FACTUAL FINDINGS (FF)
FF 1. Examiner finds that Foldvari and Anderson fail to disclose a biphasic
vesicle composition comprising 2,6-di-tert-butoxyphenol (Ans. 2—3; see
generally id. at 4).
FF 2. Examiner relies on Hellerbrand to disclose “vesicle compositions
[comprising] antioxidants such as ascorbic acid, tocopherol and methionine”
(Ans. 3; see generally id. at 4).
FF 3. Song “relates to medical devices and more particularly to
implantable or insertable medical devices containing oxidation-sensitive
therapeutic agents” (Song 11).
FF 4. Song discloses that “[mjedical devices include medical devices . . .,
such as catheters, guide wires, balloons, filters, stents, stent grafts, vascular
grafts, vascular patches and shunts” (Song | 6).
FF 5. Song discloses that “[ajntioxidants include[, inter alia,]
alkoxyphenols such as 4-tert-butoxyphenol, 4-ethoxyphenol, 3-
methoxyphenol and 2-tert-butyl-4-methoxyphenol; [and] 2,2-methylene-bis-
7 Park et al., EP 0 211 647 Al, published Feb. 25, 1987.
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Appeal 2015-001588
Application 13/965,158
(4-methyl-6-tert-butylphenol)” (Song 124; see generally id. ]Hf 24—29; Ans.
3).
FF 6. Examiner relies on Park to disclose “a method of making liposomes
[] that [include] arginine [as] a hydrating agent which produces highly stable
liposomes in aqueous solution having a very high capture capacity” (Ans. 4).
ANALYSIS
The issue with respect to both of Examiner’s rejections is the same.
Therefore, we address both rejections together.
Based on the combination of Foldvari, Anderson, and Song, with or
without Hellerbrand, Examiner concludes that, at the time Appellant’s
invention was made, it would have been prima facie obvious to include
Appellant’s “claimed butoxyphenol in the compositions of Foldvari and
Anderson[, with or without] Hellerbrand[, because] Song teaches
alkoxyphenols and tocopherols are antioxidants” (Ans. 4). In this regard,
Examiner finds “that Song does not teach” 2,6-di-tert-butoxyphenol, but,
nonetheless, asserts that 2,6-di-tert-butoxyphenol is an “art[-]known
antioxidant[]” (see Ans. 3 and 6).
Based on the combination of Foldvari, Anderson, and Park, with or
without Hellerbrand, Examiner concludes that, at the time Appellant’s
invention was made, it would have been prima facie obvious to include
arginine, as suggested by Park, in the biphasic vesicle composition
suggested by the combination of Foldvari and Anderson, with or without
Hellerbrand to produce a stable liposomal dispersion (see Ans. 4).
We are not persuaded that Examiner established an evidentiary basis
on this record to support a conclusion that the combination of Foldvari and
Anderson, taken with Song or Park, with or without Hellerbrand, makes
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Appeal 2015-001588
Application 13/965,158
obviousness a biphasic vesicle composition comprising, inter alia, 2,6-di-
tert-butoxyphenol.
As Appellant explains, “none of the cited references teach or suggest
[the] use of the specific compound 2,6-di-tert-butoxyphenol as an
antioxidant, let alone in a biphasic vesicle composition” (App. Br. 9). To the
contrary, as Appellant makes clear, “the only basis for [Examiner’s]
rejections is an allegation that 2,6-di-tert-butoxyphenol (which is not even
mentioned in any of the five cited references) is an art-known antioxidant”
(Reply Br. 2; cf. FF 1—6; Ans. 3 and 6). In this regard, Appellant contends
that:
Examiner has not identified, or even attempted to identity, any
reason for a person skilled in the art to choose the particular
compound 2,6-di-tert-butoxyphenol while ignoring all
antioxidants taught in the cited art. Indeed, the Examiner
cannot identify such a reason, since the cited references not
only fail to provide any reason, but also fail to even mention
this particular compound!
(Reply Br. 2—3; see id. at 3 (“the references do not provide any reason to
pick this compound if for no other reason that this compound is not
mentioned in any of the references”).) We agree (see FF 1—6). In re Kahn,
441 F.3d 977, 988 (Fed. Cir. 2006) (“rejections 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”).
CONCFUSION OF FAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion that the combination of Foldvari and Anderson, taken
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Application 13/965,158
with Song or Park, with or without Hellerbrand, makes obviousness a
biphasic vesicle composition comprising, inter alia, 2,6-di-tert-butoxyphenol
The rejection of claims 1—3 and 5—13 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Foldvari, Anderson, and Song, with or
without Hellerbrand, is reversed.
The rejection of claims 1—3 and 5—13 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Foldvari, Anderson, and Park, with or
without Hellerbrand, is reversed.
REVERSED
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