Ex Parte Manion et al

Board of Patent Appeals and Interferences

Sep 14, 2010

11147962 (B.P.A.I. Sep. 14, 2010)

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.
11/147,962 06/08/2005 Carl V. Manion OMRF 01501 PTUS 8093
27829 7590 09/15/2010
Eugenia S. Hansen
Hemingway & Hansen, LLP
Comerica Bank Tower Suite # 2500
1717 Main Street
Dallas, TX 75201
EXAMINER
FISHER, ABIGAIL L
ART UNIT PAPER NUMBER
1616
MAIL DATE DELIVERY MODE
09/15/2010 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
_________________

Ex parte CARL V. MANION, ALLEN B. EDMUNDSON, JOHN E.
ADAMS and TONY E. HUGLI,

Appellants.
_________________

Appeal 2010-004889
Application 11/147,962
Technology Center 1600
_________________

Before SALLY GARDNER LANE, RICHARD E. TORCZON and SALLY
C. MEDLEY, Administrative Patent Judges.

LANE, Administrative Patent Judge.

DECISION ON APPEAL1

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode shown on the PTOL-90A cover letter attached to this decision.

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I. STATEMENT OF THE CASE
The appeal, under 35 U.S.C. § 134(a), is from a Final Rejection of
Appellants’ claims 1-22. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm.
Appellants’ specification is directed to treating sunburns and other
types of burns with N-L-aspartyl-L-phenyalanine 1-methyl ester (“APM”).
(Spec. ¶ [0013]).
The Examiner relied on the following patent documents:
Martin 5,652,274 July 29, 1997 (“Martin”)
Edmundson 5,654,334 August 5, 1997 (“Edmundson ‘334”)
Edmundson 6,177,467 January 23, 2001 (“Edmundson ‘467”)
Peyman 6,436,429 August 20, 2002 (“Peyman”)

The Examiner also relied upon an entry in the Merriam-Webster’s Medical
Dictionary (2005) (“Dictionary entry”).
The Examiner made the following rejections:
• Claims 1-6 and 11-13 under 35 U.S.C. § 103(a) over Peyman
and the Dictionary entry;
• Claims 7-10 and 14-22 under 35 U.S.C. § 103(a) over Peyman,
the Dictionary entry, and Martin;
• Claims 1-6 and 11-13 under the doctrine of obviousness-type
double-patenting over claims 1-2 and 12-14 of Edmundson
‘334 in view of Peyman and the Dictionary entry;
• Claims 7-10 and 14-22 under the doctrine of obviousness-type
double-patenting over claims 1-2 and 12-14 of Edmundson
‘334 in view of Peyman, the Dictionary entry, and Martin;
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• Claims 1-22 under the doctrine of obviousness-type double-
patenting over claims 1-4 of Edmundson ‘467 in view of
Martin; and
• Claim 21 under 35 U.S.C. § 112, second paragraph.
Appellants do not argue for the separate patentability of independent
claims 19, 22, or 232, or any of the dependent claims recited in their Claims
Appendix. We focus on claims 1, 15, and 18 in our analysis. See 37 C.F.R.
§ 41.37(c)(1)(vii).
II. REJECTIONS OVER PEYMAN AND THE DICTIONARY
ENTRY
Findings of Fact
1. Appellants’ claim 1 recites:
A method for treating skin burns, comprising topical
application of a preparation comprising APM having the
formula:

where R is H, CH3 or an alkyl having 2-4 carbon atoms, and a
pharmaceutical carrier to a subject in need of such treatment.

2 We note that the claim following claim 22 in Appellants’ Claims Appendix
was labeled “22.” (See App. Br. 13, Claims App’x). We assume this to be
claim 23.
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(App. Br. 11, Claims App’x).
2. N-L-aspartyl-L-phenyalanine 1-methyl ester and APM, wherein
R is CH3, are alternative names for the sweetener aspartame. (Spec.
¶ [0017]; Ans. 5).
3. Peyman teaches applying non-nutritive sweeteners, including
aspartame, topically to skin to suppress or inhibit pain and inhibit irritation.
(Peyman col. 4, ll. 37-44).
4. Appellants’ specification recognizes the known fact that
exposure to excess sun, heat, or UV light can cause the symptoms of heat,
redness, swelling, and pain.
5. Appellants’ specification states that APM provides relief for
these symptoms. (Spec. ¶ [0014]).
Analysis
The method of Appellants’ claim 1 recites treating skin burns by
applying a preparation comprising a generic compound that encompasses
aspartame. (FF 1; App. Br. 11, Claims App’x). Although Peyman does not
teach treating burns (App. Br. 5), Peyman teaches suppressing or inhibiting
pain, a symptom of burns (FFs 4 and 5; Dictionary entry and Spec.
¶ [0014]), by topically applying aspartame. (FF 3; Peyman col. 4, ll. 37-44).
Those of skill in the art would have had a reason to apply the claimed APM
compound (aspartame) to treat a skin burn. (Ans. 5-6).
Appellants raise the issue of whether Peyman teaches applying
aspartame alone or only with other agents. Appellants argue that Peyman
only teaches using an “anti-irritant”, e.g., aspartame, with a “treatment
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agent” to ameliorate side effects of the treatment agent, such as burning. 3
(App. Br. 5). By using the term “comprising,” Appellants’ claim 1 is not
limited to topical application of only the claimed APM preparation. See
Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997)
(“‘Comprising’ is a term of art used in claim language which means that the
named elements are essential, but other elements may be added and still
form a construct within the scope of the claim.”).
Another issue raised by Appellants is whether Peyman enables the use
of aspartame because its solubility properties would not allow it to substitute
for saccharine, which Appellants argue is the preferred anti-irritant taught in
Peyman. (App. Br. 5-6).
We are not persuaded by this argument. Appellants point only to their
specification for reports of the pH conditions for maximum and minimum
solubility, but do not point to the maximum solubility of APM that can be
obtained under the conditions provided in Peyman. (App. Br. 6; see Spec.
¶ [0018]). “Argument of counsel cannot take the place of evidence lacking
in the record.” Meitzner v. Mindick, 549 F.2d 775, 782 (CCPA 1977). Thus,
Appellants’ argument lacks support.
Furthermore, Peyman teaches the use of carriers and vehicles for
applying useful amounts of different non-nutritive sweeteners, including
both saccharine and aspartame. (See Peyman col. 5, ll. 1-26). Peyman does

3 Appellants do not cite to any specific portions of Peyman in support of their
argument. We remind Appellants that “[j]udges are not like pigs, hunting
for truffles buried in briefs.” Halliburton Energy Servs., Inc. v. M-I LLC,
514 F.3d 1244, 1250, n. 2 (Fed. Cir. 2008) (quoting United States v. Dunkel,
927 F.2d 955, 956 (7th Cir. 1991)).
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not provide a careful analysis of solubility, indicating that it was already
known in the art how to address any issue of limited solubility that may exist
between the different non-nutritive sweeteners.
Furthermore, we are not persuaded that because saccharine is a
preferred embodiment of Peyman, applying APM would not have been
obvious. See In re Burckel, 592 F.2d 1175, 1179 (CCPA 1979) (“Under 35
USC 103, a reference must be considered not only for what it expressly
teaches, but also for what it fairly suggests. . . . In response to the argument
that this choice, as well as other choices which must be made from among
the disclosures of the reference, is made from other than the preferred
embodiments . . . , we reiterate that ‘all disclosures of the prior art, including
unpreferred embodiments, must be considered’ in determining
obviousness.” (citations omitted)). Appellants have not provided sufficient
evidence to persuade us that though Peyman expressly teaches applying
aspartame topically to relieve pain, those of skill in the art would not have
understood how to do so.
Appellants also argue that the decision in Perricone v. Medicis
Pharm. Corp., 432 F.3d 1368 (Fed. Cir. 2005) is contrary to the rejection
under 35 U.S.C. § 103(a) over Peyman and the Dictionary entry because
application of a lotion to the skin was held to not anticipate the new use of
the lotion as a treatment for sunburn. The facts of Perricone are not
instructive for the current rejection because the prior art reference in
Perricone did not disclose any benefit directed to the goal of the claimed
method. Perricone, 432 F.3d at 1376. In contrast, Peyman teaches that
applying aspartame relieves pain, which the Dictionary entry, Appellants’
own specification, and common sense teach is a benefit directed to a skin
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burn. See KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 420-21 (2007)
(explaining that inventions resulting from “ordinary skill and common
sense” are obvious under § 103).
III. REJECTIONS OVER PEYMAN, THE DICTIONARY ENTRY,
AND MARTIN
Findings of Fact
6. Appellants’ claim 15 recites:
A method for absorbing ultraviolet-light to which skin may be
exposed and initiating the treatment of damage to skin overexposed to
the sun or a UV source as it occurs, comprising applying a
formulation comprising APM having the formula:

where R is H, CH3 or an alkyl having 2-4 carbon atoms, to the skin
prior to or during exposure to said sun or UV source.

(App. Br. 12, Claims App’x).
7. Appellants’ claim 184 recites: “A formulation for use in
absorbing a portion of ultraviolet-light to which skin may be exposed and
initiating the treatment of damage to skin overexposed to the sun or a UV

4 Appellants argue that claim 18 is separately patentable, but do not provide a
separate subheading to identify the arguments relevant to claim 18, as
required under 37 C.F.R. § 41.37(c)(vii). Nonetheless, we have considered
Appellants arguments as they pertain to claim 18.

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source as it occurs, comprising APM and a chemical blocker of UV light.”
(App. Br. 12-13, claims App’x).
8. Peyman teaches that bioactive agents capable of treating
particular conditions can be added to compositions with non-nutritive
sweeteners. (Peyman col. 6, ll. 10-15).
9. Martin teaches therapeutic sunscreen-wound healing
compositions (Martin col. 127, l. 51, through col. 138, l. 51) that include
sunscreen and anti-inflammatory agents and teaches applying such
compositions to human skin, prior to exposure to the sun. (id. col. 132, ll.
29-47 and 55-58).
Analysis
Appellants’ claim 15 recites a method for absorbing UV light and
initiating the treatment of damaged skin by applying a formulation
comprising a generic compound that encompasses aspartame, either prior to
or during sun or UV exposure. (FF 6; App. Br. 12, Claims App’x).
Appellants’ claim 18 recites a formulation that absorbs UV light and begins
treatment of damage of the skin caused by UV light, the formulation
comprising APM and a chemical blocker of UV light. (FF 7; App. Br. 12,
Claims App’x).
Peyman teaches that additional bioactive agents can be added to
compositions with non-nutritive sweeteners (FF 8; Peyman col. 6, ll. 10-15)
and Martin teaches therapeutic sunscreen-wound healing compositions that
can be applied prior to exposure to the sun. (FF 9; Martin col. 127, l. 51,
through col. 138, l. 51, and col. 132, ll. 55-58). Because both Peyman and
Martin teach compositions that are useful against UV exposure, those in the
art would have had reason to combine them. “It is prima facie obvious to
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combine two compositions, each of which is taught by the prior art to be
useful for the same purpose, in order to form a third composition which is to
be used for the very same purpose.” In re Kerkhoven, 626 F.2d 846, 850
(CCPA 1980).
In regard to claim 15, Appellants raise the issue that their method
relies on the ability of APM to absorb UV light, but that neither Martin nor
Peyman teach this concept. (App. Br. 7). Appellants do not cite to evidence
in support of their assertion that APM absorbs UV light, and the only
mention we find in their specification is a half sentence: “While APM has
some ultraviolet-light absorbing properties, . . . .” (Spec. ¶ [0014]). We
find no evidence to support this statement in Appellants’ specification. (see
Ans. 22-23). Thus, Appellants’ argument that the Examiner’s rejection is in
error because the UV light absorbing properties of APM are not recognized
in Martin or Peyman is not persuasive.
In addition, claim 15 appears to rely on the inherent ability of APM
to block UV light. Because Peyman teaches applying aspartame to relieve
pain, a symptom of sunburn, it would have been obvious to apply it during
exposure to the sun, to avoid pain that begins during exposure. See
MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir.
1999) (“Where . . . the result is a necessary consequence of what was
deliberately intended, it is of no import that the articles’ authors did not
appreciate the results.”). Thus, the teaching to apply APM in Peyman is an
inherent teaching of Appellants’ method which would have been obvious to
use in the case of a burn.
In regard to claim 18, Appellants raise the issue that Martin does not
provide any disclosure of a formulation with APM and a chemical blocker or
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UV light. (App. Br. 7-8). “Non-obviousness cannot be established by
attacking references individually where the rejection is based upon the
teachings of a combination of references.” In re Merck & Co., Inc., 800
F.2d 1091, 1097 (Fed. Cir. 1986). Because Peyman teaches a formulation of
APM and other agents, we are not persuaded by Appellants’ argument.
IV. REJECTIONS UNDER THE DOCTRINE OF OBVIOUSNESS-
TYPE DOUBLE-PATENTING
Findings of Fact
10. Claim 1 of Edmundson ‘334 recites:
A method of decreasing pain in a patient comprising
administering to said patient in need of such treatment an
effective amount of a composition comprising:

where R is H or an alkyl containing 1 to 6 carbons to effect a
reduction in perceived pain by said patient, wherein an effective
amount of said composition is from about 80 milligrams to
about 320 milligrams.

(Edmundson ‘334, col. 16, ll. 31-47).

11. Claim 1 of Edmundson ‘467 recites:
A method for treatment of disease effected by TNF-α in a
patient comprising administering in a treatment regimen to said
patient an effective amount of a compound comprising
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where R is H or an alkyl containing 1 to 6 carbons, wherein
said treatment regimen is capable of inhibiting TNF- α activity
over time.

(Edmundson ‘467, col. 13, ll. 39-56).
12. Edmundson ‘467 teaches that APM interferes with effects of
TNF-α in the inflammatory process. (Edmundson ‘467, col. 5, ll. 51-53).
Analysis
The Examiner rejected Appellants’ claims 1-6 and 11-13 under the
doctrine of obviousness-type double-patenting over claims 1-2 and 12-14 of
Edmundson ‘334, in view of Peyman and the Dictionary entry. (Ans. 10-
12). The Examiner rejected claims 7-10 and 14-22 under the doctrine of
obviousness-type double-patenting over claims 1-2 and 12-14 of Edmundson
‘334 in view of Peyman, the Dictionary entry, and Martin. The only issue
that Appellants raise for these rejections is that the prior patent does not
claim a method of treating burns or sunburn and so is not properly cited in
an obviousness-type double-patenting rejection. (App. Br. 8-10).
Edmundson ‘334 need only have rendered Appellants’ claimed methods and
formulations obvious, not anticipated as this is not a statutory double-
patenting rejection. Appellants have not provided any arguments or
evidence that those of skill in the art would not have considered treating a
burn to be obvious from a treatment for pain. Accordingly, Appellants have
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not persuaded us that the Examiner erred in rejecting their claims over those
of Edmundson ‘334.
The Examiner also rejected claims 1-22 under the doctrine of
obviousness-type double-patenting over Edmundson ‘467 claims 1-4, in
view of Martin. Because we determine that these claims are unpatentable
under 35 U.S.C. § 103(a) over Peyman and the Dictionary entry and under
the doctrine of obviousness-type double patenting over the claims of
Edmundson ‘334 in view of Peyman, the Dictionary entry and Martin, we
need not and do not consider the propriety of this further rejection of the
claims.
V. REJECTIONS UNDER 35 U.S.C. § 112, SECOND PARAGRAPH
The Examiner rejected claim 21 under 35 U.S.C. § 112, second
paragraph, asserting that the claim is indefinite. (Ans. 4). Because we
determine that claim 21 is unpatentable under 35 U.S.C. § 103(a), as well as
under the doctrine of obviousness-type double patenting, we need not and do
not consider this further rejection of the claim.
VI. ORDER
Upon consideration of the record and for the reasons given,
the rejection of claims 1-6 and 11-13 under 35 U.S.C. § 103(a) over
Peyman and the Dictionary entry is AFFIRMED;
the rejection of claims 7-10 and 14-22 under 35 U.S.C. § 103(a) over
Peyman, the Dictionary entry, and Martin is AFFIRMED;
the rejection of claims 1-6 and 11-13 under the doctrine of
obviousness-type double-patenting over claims 1-2 and 12-14 of Edmundson
‘334 in view of Peyman and the Dictionary entry is AFFIRMED;
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the rejection of claims 7-10 and 14-22 under the doctrine of
obviousness-type double-patenting over claims 1-2 and 12-14 of Edmundson
‘334 in view of Peyman, the Dictionary entry, and Martin is AFFIRMED;
the propriety of the rejection of claims 1-22 under the doctrine of
obviousness-type double-patenting over claims 1-4 of Edmundson ‘467 in
view of Martin has not been considered; and
the propriety of the rejection of claim 21 for indefiniteness has not
been considered.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2007).

AFFIRMED

EUGENIA S. HANSEN
HEMINGWAY & HANSEN, LLP
COMERICA BANK TOWER, SUITE 2500
1717 MAIN STREET
DALLAS, TX 75201