Ex Parte SHAPIRO et al

Board of Patent Appeals and Interferences

Feb 23, 2011

09110409 (B.P.A.I. Feb. 23, 2011)

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.
09/110,409 07/06/1998 STANLEY S. SHAPIRO JBP-430 4653
7590 02/23/2011
AUDLEY A CIAMPORCERO JR
JOHNSON AND JOHNSON
ONE JOHNSON AND JOHNSON PLAZA
NEW BRUNSWICK, NJ 089337003
EXAMINER
WEDDINGTON, KEVIN E
ART UNIT PAPER NUMBER
1614
MAIL DATE DELIVERY MODE
02/23/2011 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 STANLEY S. SHAPIRO, MIRI SEIBERG,
SUSAN NIEMEC, JOHN KUNG, and MICHAEL J. COSTANZO
__________

Appeal 2010-011042
Application 09/110,409
Technology Center 1600
__________

Before TONI R. SCHEINER, ERIC GRIMES, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of effecting changes in skin pigmentation. The Examiner rejected the claims
as anticipated and/or obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

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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Statement of the Case
The Specification teaches “a method for affecting changes in
mammalian skin pigmentation comprising topically applying to the skin of a
mammal a compound which affects the PAR-2 pathway” (Spec. 3, ll. 8-10).
According to the Specification, compositions “may contain . . . PAR-2
agonists, for increase in pigmentation” (Spec. 3, ll. 11-12). The
Specification teaches that alternate compositions “may contain one or more
compounds that act . . . as PAR-2 pathway inhibitors or as a PAR-2
antagonist for decrease in pigmentation” (Spec. 3, ll. 13-15).
The Claims
Claims 79, 82-91, 94, and 96 are on appeal. Claim 79 reads as
follows:
79. A method of effecting changes in
mammalian skin pigmentation comprising
administering to a mammal a pigmentation-
changing effective amount of a composition which
affects the PAR-2-pathway wherein said
composition comprises soybean extracts in which
proteins have not been denatured and which
comprise soy trypsin inhibitory activity.

The issue
The Examiner rejected claims 79, 82-91, and 96 under 35 U.S.C. §
102(b) as anticipated by, or in the alternative, under 35 U.S.C. § 103(a) as
obvious over Gupta2 (Ans. 3-4).
The Examiner finds that “Gupta et al. teach the preparation of soybean
extract for food without denaturing proteins (see the abstract). Note the

2 Gupta et al., US 4,915,972, issued Apr. 10, 1990.
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undenaturated soybean extract is consumed by humans; therefore, the
consumption of the undenaturated soybean extract would inherently effect
the changes in the human skin pigmentation” (Ans. 4). The Examiner finds
that “the cited reference does not teach the applicants’ preferred amount of
the soybean extract set forth in claims 86-89. However, to determine an
amount having the optimum effectiveness to change mammalian skin
pigmentation is well within the level of one having ordinary skill in the art”
(Ans. 4).
Appellants “submit that Gupta et al. very clearly indicates that it is
important to deactivate undesirable enzyme activity, including trypsin
inhibitors, in the soybean materials utilized therein. Appellants respectfully
contend that Gupta et al. neither explicitly nor implicitly describes the
methods or compositions of appellants’ claims” (App. Br. 7). Appellants
contend that “nowhere does Gupta et al. suggest or describe soy-derived
compositions that have not been denatured. Nor, notably, does Gupta et al.
suggest or direct one to place the compositions that are described topically
on the skin” (App. Br. 7).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Gupta teaches or suggests the
limitations of claim 79?
Findings of Fact
1. The Specification teaches, in the “Summary of the Invention”
section, that “we have found a method for affecting changes in mammalian
skin pigmentation comprising topically applying to the skin of a mammal a
compound which affects the PAR-2 pathway” (Spec. 3, ll. 8-10).
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2. The Specification teaches that the “compounds which are active
in the compositions and methods of this invention may be delivered topically
by any means known to those of skill in the art” (Spec. 13, ll. 1-2).
3. The Specification teaches that if the “delivery parameters of the
topically active pharmaceutical or cosmetic agent so require, the topically
active composition of this invention may preferably be further composed of
a pharmaceutically or cosmetically acceptable vehicle capable of functioning
as a delivery system to enable the penetration of the topically active agent
into the skin” (Spec. 13, ll. 3-7).
4. The Specification teaches that as “used herein ‘amount
effective’ shall mean an amount sufficient to cover the region of skin surface
where a change in pigmentation is desired” (Spec. 14, ll. 29-31).
5. Gupta teaches:
A method is disclosed for producing protein foods and
edible oils from protein and oil containing seeds which
comprises disintegrating the seeds in an oxygen-free
environment, such that air is prevented from entering in and
mixing with said environment, to prevent seed enzymes
from producing off-flavors and bitter taste without heat
treating seeds to inactivate the enzymes and concomitantly
insolubilize the seed proteins. Artificial milk extracted from
soybeans using this method has no-beany flavor, bitter taste,
or chalkiness. Flaking of soybeans employing this method
gives bland flakes without denaturing proteins. Such flakes
are suitable for making highly functional palatable protein
foods.

(Gupta, abstract).
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6. Gupta teaches that “inactivating enzymes for the purpose of
controlling off-flavors after disintegrating the seeds is not necessary in the
present invention” (Gupta, col. 3, ll. 35-37).
7. Gupta teaches that “[h]owever, inactivating enzymes in the
disintegrated seed products at a convenient step in processing is
recommended to improve the nutritional quality of the foods and to
simultaneously get rid of any residual undesirable enzyme activity” (Gupta,
col. 3, ll. 38-41).
8. Example 6 of Gupta teaches preparation of soymilk where “the
slurry transferred to a pressure cooker and the slurry cooked for a few
minutes at 15 p.s.i. pressure to inactivate trypsin inhibitor” (Gupta, col. 6, ll.
18-20).
9. Embodiment 5 of Gupta teaches “heating the extracted oil
sufficiently to inactivate lipoxygenase enzyme” (Gupta, col. 4, ll. 36-38).
10. Embodiment 6 of Gupta teaches “heating the extracted oil
sufficiently to inactivate lipoxygenase enzyme” (Gupta, col. 4, ll. 47-48).
Principles of Law
“[A]nticipation of a claim under § 102 can be found only if the prior
art reference discloses every element of the claim ….” In re King, 801 F.2d
1324, 1326 (Fed. Cir. 1986) (citing Lindemann Maschinenfabrik GMBH v.
American Hoist and Derrick Co., 730 F.2d 1452, 1457 (Fed. Cir. 1984)).
“Inherency … may not be established by probabilities or possibilities.
The mere fact that a certain thing may result from a given set of
circumstances is not sufficient.” MEHL/Biophile Int’l. Corp. v. Milgraum,
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192 F.3d 1362, 1365 (Fed. Cir. 1999) (quoting In re Oelrich, 666 F.2d 578,
581 (CCPA 1981)).
An invention “composed of several elements is not proved obvious
merely by demonstrating that each of its elements was, independently,
known in the prior art….[I]t can be important to identify a reason that would
have prompted a person of ordinary skill in the relevant field to combine the
elements in the way the claimed new invention does.” KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007).
Analysis
Claim interpretation is at the heart of patent examination because
before a claim is properly interpreted, its scope cannot be compared to the
prior art. In this case, the issue is whether the requirement of claim 79 of
“administering to a mammal a pigmentation-changing effective amount” is
limited to topical administration. Appellants contend that “[n]or, notably,
does Gupta et al. suggest or direct one to place the compositions that are
described topically on the skin” (App. Br. 7).
During prosecution, claim terms are given their broadest reasonable
interpretation as they would be understood by persons of ordinary skill in the
art in the light of the Specification. Therefore, we first turn to the
Specification to determine whether the meaning of the phrase “administering
to a mammal a pigmentation-changing effective amount” can be discerned.
The Specification solely teaches topical administration (FF 1-4). The
Specification expressly teaches that the “compounds which are active in the
compositions and methods of this invention may be delivered topically by
any means known to those of skill in the art” (Spec. 13, ll. 1-2; FF 2;
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emphasis added). The Specification teaches that as “used herein ‘amount
effective’ shall mean an amount sufficient to cover the region of skin surface
where a change in pigmentation is desired” (Spec. 14, ll. 29-31; FF 4).
The Examiner does not specifically address claim interpretation, but
instead contends that “consumption of the undenatured soybean extract
would inherently effect the changes in the human skin pigmentation” (Ans.
4). The Examiner therefore implicitly argues for an interpretation of
“administering” which encompasses oral consumption.
We find that Appellants have the better position. The Specification is
entirely devoted to topical administration and the phrase “effective amount”
is expressly defined as an amount “sufficient to cover the region of skin
surface where a change in pigmentation is desired” (Spec. 14, ll. 29-31; FF
4). This express definition makes sense only in the context of topical
administration.
Further, we are not persuaded by the Examiner’s inherency argument
(Ans. 4). The Examiner provides no reason or evidence to think it even
probable, much less necessary, that oral administration of soybean extract
would result in the same change in skin pigmentation as topical
administration. When relying upon a theory of inherency, the Examiner
must provide a basis in fact and/or technical reasoning to reasonably support
the Examiner’s determination that the allegedly inherent characteristic
necessarily flows from the teachings of the applied prior art. Ex parte Levy,
17 USPQ2d 1461, 1463-64 (BPAI 1990). Here, the Examiner merely makes
a determination without providing any basis in fact and/or technical
reasoning (see Ans. 4). No factual support is provided by the Examiner, nor
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did the Examiner provide any technical reasoning to show that the oral
administration of soy extract of Gupta would reasonably be expected to
inherently result in the same changes in skin pigmentation which are caused
by topical administration as in the instant Specification.
While the Examiner rejected the claims under both 35 U.S.C. § 102(b)
and 35 U.S.C. § 103(a), the Examiner provided no reasoning as to why
topical administration would have been obvious over Gupta.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Gupta teaches or suggests the limitations of claim 79.
SUMMARY
In summary, we reverse the rejection of claims 79, 82-91, and 96
under 35 U.S.C. § 102(b) as anticipated by, or in the alternative, under 35
U.S.C. § 103(a) as obvious over Gupta.

REVERSED

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AUDLEY A CIAMPORCERO JR
JOHNSON AND JOHNSON
ONE JOHNSON AND JOHNSON PLAZA
NEW BRUNSWICK NJ 08933-7003