Ex Parte Berry

Patent Trial and Appeal Board

Oct 31, 2013

12661567 (P.T.A.B. Oct. 31, 2013)

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.
12/661,567 03/19/2010 Don Wayne Berry 031710 1143
7590 10/31/2013
Christopher J. Whewell
Western Patent Group
6020 Tonkowa Trail
Georgetown, TX 78628
EXAMINER
PALLAY, MICHAEL B
ART UNIT PAPER NUMBER
1617
MAIL DATE DELIVERY MODE
10/31/2013 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte DON WAYNE BERRY
__________

Appeal 2013-004387
Application 12/661,567
Technology Center 1600
__________

Before TONI R. SCHEINER, DEMETRA J. MILLS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 from the final rejection of
claims 15-17, 19, 21, and 26-32, directed to a method of treating pre-
cancerous skin lesions in mammals. The claims 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 Berry Pharmaceuticals,
LLC (App. Br. 3).

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STATEMENT OF THE CASE
Claims 15-17, 19, 21, and 26-32 are pending and on appeal. Claims
1-14, 22-25, 33, and 41-44 have been withdrawn from consideration as
“drawn to nonelected inventions and species” (Final Rej. 2).2
In addition, we note that Appellant elected the species “pre-cancerous
lesions” for examination on the merits, without traverse, in the Response to
Election/Restriction dated January 10, 2011. Accordingly, it is our
understanding that the claims have been examined only to the extent they
read on the elected species: pre-cancerous lesions (see Final Rej. 4).
Claim 15 is representative of the subject matter on appeal, and is
reproduced below:
15. A method for treating a disorder present in or on a mammalian subject
which method comprises contacting a composition containing a Hamelia
patens extract to the skin of said subject in an effective amount and
frequency for reducing symptoms of a disorder selected from the group
consisting of: pre-cancerous lesions, keratotic lesions and radiation-induced
burns.
The Examiner relies on the following evidence:
Mentrup Edgar et al. US 5,498,420 Mar. 12, 1996
Herzog US 2003/0235540 A1 Dec. 25, 2003
LESLIE TAYLOR, THE HEALING POWER OF RAINFOREST HERBS, A GUIDE TO
UNDERSTANDING AND USING HERBAL MEDICINALS 144-145, 417-420, 505
(2005).
Janine G. Einspahr et al., Chemoprevention of human skin cancer, 41
CRITICAL REVIEWS IN ONCOLOGY/HEMATOLOGY 269-285 (2002).
Appellants rely on the following additional evidence:

2 Final Rejection mailed August 17, 2012.
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Ana M. López Abraham et al., Extracts from plants with cytostatic
properties growing in Cuba, Part II, 31 REV. CUBANA. MED. TROP 105-111
(1979) (all references are to the English language translation, pages 1-10).
Declaration of Dr. Cloyce L. Stetson III, submitted under the provisions of
37 C.F.R. §1.132, dated February 14, 2012 (“Stetson Decl.”).
Declaration of Dr. David W. Hobson, submitted under the provisions of
37 C.F.R. §1.132, dated June 13, 2012 (“Hobson Decl.”).
Declaration of Dr. Clifton David Fuller, submitted under the provisions of
37 C.F.R. §1.132, dated July 6, 2012 (Fuller Decl.”).
Declaration of Dr. Debabrata Saha, submitted under the provisions of
37 C.F.R. §1.132, dated July 18, 2012 (Saha Decl.”).
The Examiner rejected the claims as unpatentable under 35 U.S.C.
§ 103(a) as follows:
Claims 15-17, 19, 21, 26, and 30-32 over Taylor and Einspahr (Final
Rej. 3-8).
Claims 15, 27, and 28 over Taylor, Einspahr, and Herzog (Final Rej.
8-9).
Claims 15 and 29 over Taylor, Einspahr, and Mentrup Edgar (Final
Rej. 9-11).
FINDINGS OF FACT
The following findings of fact (FF) are supported by a preponderance
of the evidence of record.
Taylor
1. Taylor discloses that the main actions attributed to the leaves
and stems of Hamelia patens are “analgesic, anti-inflammatory, antiseptic,
febrifuge (reduces fever), refrigerant (reduces body temperature)” (Taylor
144, col. 3), and the main topical uses of the plant include “as a topical anti-
inflammatory and analgesic (pain-reliever) remedy for skin problems
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(rashes, bites, stings, etc.) and for bruises, strains, muscle aches, sprains,
etc.” and “as a topical astringent, antiseptic, and antimicrobial remedy for
wounds, cuts, burns, skin fungi, etc.” (id. at 144, col. 4).
2. Taylor also teaches that Hamelia patens “has also been
documented with diuretic effects and was shown to inhibit the growth of
tumor and bacteria cells” (Taylor 419), citing López Abraham (number 15 in
Taylor’s bibliography) as evidence of anti-tumor activity of Hamelia patens.
3. López Abraham discloses that aqueous, alcohol, and ketone
extracts of Hamelia patens exhibit cytostatic activity against Neurospora
crassa, a type of bread mold (López Abraham 1-3).
4. Finally, Taylor reports the use of Hamelia patens “for cancer”
in the Amazonia region (Taylor 419). However, Taylor does not specify
what type of cancer[s] Hamelia patens is used to treat, or whether the plant
is used topically or ingested.
The Fuller, Stetson, Hobson, and Saha Declarations
5. Dr. Fuller, after reviewing the English language translation of
the López Abraham article, cited in Taylor, asserts that “the statement of
percentage inhibition by Hamelia patens therein was made solely in
reference to the growth rate of a line of cells . . . of the plant Neurospora
crassa” (Fuller Decl. ¶¶ 7, 9), and that
It is my professional opinion that all credible researchers realize
that knowledge of a particular material having
cytostatic/cytotoxic activity with respect to particular cells . . .
of one particular plant species, would not be reasonably
interpreted or extrapolated as indicating that the same particular
material would exhibit the same effect in any dermal cell lines
of any mammalian species, and that cytostatic/cytotoxic activity
in the kingdom Plantae does not imply direct corollary activity
in animal models.
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(Id. at ¶ 10).
Drs. Stetson, Hobson, and Saha make similar statements in their
Declarations (see ¶¶ 11, 12 of the Stetson Decl.; ¶¶ 15-17 of the Hobson
Decl.; and ¶¶ 9, 10 of the Saha Decl.).
Einspahr
6. According to Einspahr, “[c]ancer chemoprevention strategies, if
effective, could prevent or delay the occurrence of cancer in high-risk
populations, such as those with premalignant lesions” (Einspahr 273, col. 1),
like premalignant actinic keratosis (AK) (id. at 270, col. 2).
DISCUSSION
There are three obviousness rejections, each based, in whole or in
part, on the Examiner’s proposed combination of Taylor and Einspahr. The
issue raised by each of the rejections is whether the Examiner has
established by a preponderance of the evidence that it would have been
obvious for one of ordinary skill in the art to treat pre-cancerous skin lesions
by applying a composition comprising an extract of Hamelia patens, given
the teachings of Taylor and Einspahr.
The Examiner finds that Taylor “discloses hamelia patens as having
antitumorous properties and having use in humans as a topical remedy to
treat ‘all types of skin problems,’ skin disorders, skin diseases, rashes, sores,
wounds, burns, and cancer” and having “been shown to inhibit the growth of
tumor cells” (Final Rej. 4). The Examiner finds that “[i]t can be prepared as
a poultice, decoction, infusion, tincture, tea, or boiled in water (i.e., extract)
and . . . applied topically or internally” (id.). The Examiner acknowledges
that Taylor “does not specifically disclose the disorder as pre-cancerous
lesions” (id.), but finds that Einspahr “cures the deficiency of Taylor by
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teaching treatment of pre-cancerous lesions . . . using chemopreventive
natural products in order to reduce the incidence of cancer as well as pre-
cancerous lesions” (id. at 5).
The Examiner concludes that it would have been obvious for one of
ordinary skill in the art “to combine these teachings in order to treat and
reduce the incidence of pre-cancerous lesions” (id.), “by topically applying
to human skin the hamelia patens extract of Taylor” (id.), because Taylor
and Einspahr “are each directed to chemopreventive natural products applied
topically” (id.), and Taylor “discloses hamelia patens as a natural product
that inhibits the growth of tumor cells” (id. at 6).
Appellant contends, in relevant part, that that “the words ‘all types of
skin problems’, ‘antitumorous’, and ‘cancer’ in the Taylor reference are each
broad genus statements of classes . . . and no direction as to relevant
particular species [to be treated] within these genera is provided” (App. Br.
6). Moreover, Appellant contends that the Saha and Fuller Declarations
“refute the notion that Hamelia patens would be expected to be able to treat
‘all types of skin problems’” (id. at 8); and that the tumor inhibition
discussed in Taylor “relates to a single line of plant cells and is not
extrapolable [sic] to mammals” (id. at 11), and Taylor does not even specify
that the tumors are malignant (id. at 12, 13). Finally, Appellant contends
that Taylor’s reference to the use of Hamelia patens “for cancer”
“encompass[es] a broad class of conditions” and “does not lead a person of
ordinary skill in the art to . . . envisage any particular mammalian cancer or
cancer type” (id. at 14), and “[n]o reasonable person would believe that
Hamelia patens is capable of treating all cancers” (id. at 15).
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We will reverse these rejections. An obviousness analysis requires,
among other things, consideration of two factors:
(1) whether the prior art would have suggested to those of
ordinary skill in the art that they should make the claimed
composition or device, or carry out the claimed process; and (2)
whether the prior art would also have revealed that in so
making or carrying out, those of ordinary skill would have had
a reasonable expectation of success. Both the suggestion and
the reasonable expectation of success must be founded in the
prior art, not in the applicant’s disclosure.
In re Vaeck, 947 F.2d 488, 493 (Fed. Cir. 1991) (citation omitted).
Taylor’s reference to “all types of skin problems” is clearly just a
colloquial expression for a wide variety of skin problems, rather than an
assertion that that an extract of Hamelia patens can cure every possible type
of skin problem. Nevertheless, we agree with Appellant that Taylor’s
disclosure would not have given one of ordinary skill in the art a reason to
treat “pre-cancerous” lesions with Hamelia patens in the first place, much
less provided one of skill in the art with a reasonable expectation of success,
as Taylor lists a wide variety of skin conditions, but none even remotely
related to skin cancer or pre-cancerous lesions (FF1).
Moreover, Taylor’s only reference to tumor inhibition concerns plant
cells (FFs 2, 3), and Appellant has provided unrefuted evidence that persons
of ordinary skill in the art would not extrapolate data showing cytostatic or
cytotoxic activity in plant cells to mammalian cells, as required by claim 15
(FF5).
Similarly, Taylor’s cursory reference to the ethnomedical use of
Hamelia patens “for cancer” in Amazonia and elsewhere (FF4), with no
further explanation or citation, would not have suggested treating pre-
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cancerous skin lesion with Hamelia patens to one of ordinary skill in the art,
certainly not with any reasonable expectation of success.
Therefore, we cannot agree with the Examiner’s finding that Taylor
teaches or suggests, or is in any way “directed to chemopreventive natural
products applied topically” (Final Rej. 5). Nor can we agree with
Examiner’s finding that Taylor “discloses hamelia patens as a natural
product that inhibits the growth of tumor cells” in mammals as required by
claim 15 (id. at 6). As these findings form the basis of the Examiner’s
rationale for combining the teachings of Taylor and Einspahr, we find the
Examiner’s conclusion of obviousness is not supported by a preponderance
of the evidence of record.
The Herzog and Mentrup Edgar references, cited as disclosing topical
preparations containing nanoparticles and liposomes, respectively, do not
cure the underlying deficiency in the Examiner’s proposed combination of
Taylor and Einspahr.
SUMMARY
The rejection of claims 15-17, 19, 21, 26, and 30-32 over Taylor and
Einspahr is reversed.
The rejection of claims 15, 27, and 28 over Taylor, Einspahr, and
Herzog is reversed.
The rejection of claims 15 and 29 over Taylor, Einspahr, and Mentrup
Edgar is reversed.

REVERSED
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