Ex Parte Berkson et al

Patent Trial and Appeal Board

Oct 25, 2013

11924871 (P.T.A.B. Oct. 25, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte LINDSEY BERKSON and KENNETH G. BURTON
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Appeal 2012-000837
Application 11/924,871
Technology Center 1600
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Before DEMETRA J. MILLS, LORA M. GREEN, and
ERICA A. FRANKLIN, Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to topical
medicaments comprising nitroglycerin and curcumin. The Patent Examiner
rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

STATEMENT OF THE CASE
Claims 1-7 are on appeal. Claim 1 is representative and reads as
follows:

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1. A topical, medicinal composition comprising:
nitroglycerin; and curcumin.

The Examiner rejected the claims as follows:
• claims 1-5 under 35 U.S.C. § 103(a) as unpatentable over
Joe,1Sidhu2 and Pipelzadeh;3 and
• claims 6 and 7 under 35 U.S.C. § 103(a) as unpatentable over Joe,
Sidhu, Pipelzadeh and Barbul.4

OBVIOUSNESS
The Examiner found that Joe taught that turmeric, a powder obtained
from Curcuma longa rhizomes, was traditionally used in Ayurvedic
medicine to topically treat wounds and other skin ailments. (Ans. 6.) The
Examiner found that Joe taught that the active ingredients in turmeric are
curcuminoids, with curcumin being most abundant among them. (Id.) The
Examiner found that Joe describes curcumin as “the [most] important active
ingredient responsible for the biological activity of turmeric,” having proven

1 B. Joe et al., Biological Properties of Curcumin-Cellular and Molecular
Mechanisms of Action, 44 CRITICAL REVIEWS IN FOOD SCIENCE AND
NUTRITION 97-111 (2004).
2 Gurmel S. Sidhu et al., Curcumin enhances wound healing in
streptozotocin induced diabetic rats and genetically diabetic mice, 7 WOUND
REPAIR AND REGENERATION 362-374 (1999).
3 Mohammed Hassan Pipelzadeh et al., A Study on the Effects of Modulation
of Intracellular Calcium on Excisional Wound Healing in Rabbit, 7 IRAN.
BIOMED. J. 161-166 (2003).
4 Patent Application Publication No. US 2003/0091601 A1 by Adrian Barbul
et al., published May 15, 2003.

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anti-inflammatory and anti-cancer properties. (Id.) Regarding wound
healing, the Examiner found that Joe stated:
Curcumin enhances cutaneous wound healing in rats and guinea
pigs by increasing the formation of granulation tissue,
biosynthesis or extracellular matrix proteins, and TGF-/β1 in
wounds … accelerated wound healing in streptozotocin-induced
diabetic swiss albino rats and genetically diabetic (C57/KsJ-
db+/db+) mice by increasing the formation of granulation
tissue, faster re-epithelialization, and increased collagenization
...[.] Systemic treatment with curcumin after local muscle
injury leads to faster restoration of normal tissue architecture, as
well as an increased expression of biochemical markers
associated with muscle regeneration….

(Id. at 7)(quoting Joe at 103). Therefore, the Examiner found that “the
wound-healing properties of curcumin were scientifically tested and verified
as being effective.” (Id.) However, the Examiner found that Joe did not
teach a composition comprising curcumin and nitroglycerin. (Id.)
The Examiner found that Sidhu, cited by Joe, also taught “that
curcumin enhanced wound healing via the formulation of granulation tissue
and biosynthesis of extracellular matrix proteins and TGF-β in wounds.”
(Id. at 8.) The Examiner found that Sidhu also demonstrated the ability of
curcumin to accelerate wound healing in more complex diabetic wounds.
(Id.) Specifically, the Examiner found that Sidhu disclosed that a topical
treatment of diabetic full cutaneous wounds comprising 0.1% curcumin in a
PEG base provided an advanced healing response as compared to a control.
(Id.)
Additionally, the Examiner found that Pipelzadeh taught that an
ointment comprising 2% nitroglycerin in a Vaseline base, i.e., a viscous
carrier medium, accelerated wound healing in a statistically significant
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manner and also provided greater tensile strength as compared to a control.
(Id. at 9.) The Examiner found that Pipelzadeh proposed the use of topical
nitroglycerin for promoting faster healing, producing stronger wounds and
limiting scar formation. (Id.)
According to the Examiner, it would have been obvious to a person of
ordinary skill in the art at the time the invention was made to have combined
curcumin and nitroglycerin for their known benefits since each was well
known in the art for treating wounds. (Ans. 10.)(citing In re Kerkhoven, 626
F.2d 846, 850 (CCPA 1980) and In re Sussman, 136 F.2d 715, 718 (CCPA
1943).
We agree with the Examiner that these applied references evince a
prima facie case of obviousness for claim 1.
Appellants’ nonobviousness position is premised on their contention
that while “some healing effects would be expected through the use of the
individual ingredients,” i.e., curcumin and nitroglycerin, the claimed
invention exhibits superior and unexpected results over the cited art, as
evidenced by the declarations of Lindsey Berkson and Jack Moncrief, M.D.
(App. Br. 6.)
While evidence of unexpected results can be used to rebut a prima
facie case of obviousness, Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1369-
70 (Fed. Cir. 2007), it is well settled that such results must be established by
factual evidence, In re Lindner, 457 F.2d 506, 508 (CCPA 1972). Mere
argument or conclusory statements in the specification does not suffice.
(Id.)
After considering all the evidence and arguments, we conclude that
Appellants have not presented evidence of unexpected results sufficient to
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rebut the Examiner’s prima facie case of obviousness. See In re Rinehart,
531 F.2d 1048, 1052 (CCPA 1976)(“When prima facie obviousness is
established and evidence is submitted in rebuttal, the decision-maker must
start over.”); see also In re Hedges, 783 F.2d 1038, 1039 (Fed. Cir. 1986)
(“If a prima facie case is made in the first instance, and if the applicant
comes forward with reasonable rebuttal, whether buttressed by experiment,
prior art references, or argument, the entire merits of the matter are to be
reweighed”).
Appellants assert that “[t]he results of the current invention were
superior regarding the shared property of wound healing.” (App.Br. 6.)
Appellants support this assertion by referring to a disclosure in the
Specification that “the present invention increases blood flow to the wound,
expedites growth of new islands cells, allows skin to take root and grow,
eliminates need for debridement and substantially eradicates pernicious
microbes.” (Id. at 7)(citing Spec. 13-14). However, as the Examiner
explained, Appellants have not provided evidence that these features of the
claimed invention would not have been expected. (See Ans. 16-17.)
Appellants also rely on the Berkson Declaration as showing superior
results, and the Moncrief Declaration as addressing the superior results.
(App. Br. 7.) According to Appellants, this declaratory evidence
demonstrates that “[t]he claimed invention provides significant results by the
fourth day post-treatment that are not even registered until 2 weeks or longer
in the cited art using the individual ingredients.” (Id.) While we recognize
the apparent expertise of each declarant in their designated fields, we do not
afford their testimony persuasive weight. In particular, neither declaration
provides a detailed description of an experiment from which the “results of
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the claimed invention” were derived, much less a side-by-side comparison
with the closest prior art. See In re Baxter Travenol Labs., 952 F.2d 388,
392 (Fed. Cir. 1991)(“[W]hen unexpected results are used as evidence of
nonobviousness, the results must be shown to be unexpected compared with
the closest prior art.”).
Moreover, an assertion that “far more advanced stages of healing are
observed only 4 days after treatment with the claimed invention” is merely
an assertion of degree, i.e., the rate of wound healing, and not of a different
kind. See Pfizer, 840 F.3d at 1371(Superiority alone is inadequate to
establish nonobviousness; the superiority must be unexpected.); see also In
re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996)(To be unexpected, the result
must be different in kind, not just degree).
Further, Appellants assert that “the claimed invention has the
unexpected property of continued efficacy with [] nitroglycerin in
combination with curcumin, wherein the nitroglycerin in the claimed
invention does not appear to rapidly dissipate in effect and the patients do
not develop nitroglycerin tolerance ….” (App. Br. 7-8)(emphasis
added)(citing Berkson Decl. ¶¶ 10-11 and 13-16; Moncrief Decl. ¶¶ 11-14
and 25-26). However, as discussed, neither declaration provides a side-by-
side comparison of the claimed invention and the closest prior art.
Moreover, the declaratory evidence does not establish that the asserted
continued wound healing observed in the patients treated with a combination
of nitroglycerin and curcumin was attributable to a “continued efficacy” of
nitroglycerin and not the activity of the combined curcumin. In other words,
Appellants have not established that a skilled artisan at the time of the
invention would not have expected a composition combining nitroglycerin
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and another well-known wound healing agent to provide effective wound
healing for a duration longer than what would allegedly be expected with
nitroglycerin alone.
Finally, Appellants assert that with the claimed invention, “[t]here is
also an absence of an expected property regarding headaches from [the] use
of nitroglycerin alone or in other combinations.” (App. Br. 8.) According to
Appellants, “[t]hese headaches do not appear to be a problem with the
claimed invention and were not reported by the patients.” (Id.)(Emphasis
added). However, Appellants have again failed to provide comparative
evidence to support this contention. See Lindner, 457 F.2d at 508.
For the above stated reasons, Appellants have failed to carry their
burden of rebutting the Examiner’s prima facie case of obviousness by a
preponderance of the evidence. See Rinehart, 531 F.2d at 1052.
Accordingly, we affirm the obviousness rejection of claim 1. Claims 2-5
have not been argued separately and therefore fall with claim 1. 37 C.F.R.
§ 41.37(c)(1)(vii). Regarding claims 5 and 6, Appellants repeat the same
arguments raised for claim 1. (See App. Br. 17-28.) Accordingly, we affirm
the rejection of claims 5 and 6 for the same reasons discussed regarding the
rejection of claim 1.

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SUMMARY
We affirm each of the obviousness rejections.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

cdc