Ex Parte Renzin et al

Patent Trial and Appeal Board

Nov 21, 2013

11996845 (P.T.A.B. Nov. 21, 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.
11/996,845 02/11/2008 Stephen M. Renzin 1021-0002WOUS 1237
50811 7590 11/21/2013
O''Shea Getz P.C.
1500 MAIN ST. SUITE 912
SPRINGFIELD, MA 01115
EXAMINER
ANDERSON, CATHARINE L
ART UNIT PAPER NUMBER
3778
MAIL DATE DELIVERY MODE
11/21/2013 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 STEPHEN M. RENZIN and WILLIAM SCHMITT
__________

Appeal 2012-002381
Application 11/996,845
Technology Center 3700
__________

Before TONI R. SCHEINER, LORA M. GREEN, 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 1-20, directed to a method of treating skin irritation and/or
inflammation. The claims have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We reverse.

1 Appellants identify the Real Party-In-Interest as Femaceuticals LLC, of
Larchmont, NY (App. Br. 2).

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STATEMENT OF THE CASE
Claims 1-20 are pending and on appeal. Claim 15 represents the
invention in its broadest aspect, and is reproduced below:
15. A method for treating skin irritations and/or inflammation resulting
from breast feeding of newborns, diaper rash, incontinence rash,
hemorrhoids, burns, insect bites, and the like, said method comprising:
a) covering the skin irritation with an absorbent pad which contains a
cooling component and a dry milk component, said milk component
contacting the skin irritation/inflammation; and
b) retaining said pad in contact with the skin irritation/inflammation
during the period of treatment.
The Examiner relies on the following evidence:
Young et al. US 3,959,491 May 25, 1976
Lange et al. US 2003/0105445 A1 Jun. 5, 2003
Nutritional Components in Milk, Cornell University
http://www.milkfacts.info/Nutrition%20Facts/Nutritional%20Components.h
tm
Appellants rely on the following additional evidence:
Exhibit A: Omega-3 fatty acids,
http://www.umm.edu/altmed/articles/omega-3-000316.htm
Exhibit B: Omega-3 fatty acid, http://en.wikipedia.org/wiki/Omega-
3_fatty_acid
Claims 1-20 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over Lange and Young.
FINDINGS OF FACT
The following findings of fact (FF) are supported by a preponderance
of the evidence of record.
1. Lange discloses:
The present invention provides breast pads incorporating
a composition comprising a skin benefit ingredient for use by
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expectant and/or nursing mothers whose breasts have enlarged
due to the presence of milk. During breast feeding, a mother
can lose a significant amount of lipids from the breast and
nipple skin resulting in inflammation, redness and potential
infection to the breast and/or nipple. In accordance with the
present invention, a composition comprising a lipid comprising
omega-3 fatty acids is introduced onto the surface of the breast
pad . . . such that the omega-3 fatty acids can be transferred
from the breast pad to the mother’s breast skin and nipple
during use to replenish skin lipids lost from the breast and
nipple skin during breast feeding. Along with providing a skin
health benefit to the mother by replacing lost breast and nipple
skin lipids and thereby improving skin barrier functions,
omega-3 fatty acids can be ingested by the suckling baby to
increase the amount of omega-3 fatty acids in the baby’s diet to
improve health.
(Lange ¶ 6.)
2. The fatty acids in Lange’s composition comprise alpha
linolenic acid, eicosapentaenoic acid, and docosahexaenoic acid (omega-3
fatty acids), as well as linoleic acid (an omega-6 fatty acid) (Lange ¶ 11, 30,
36).
3. Lange teaches that “[t]he composition may be in a variety of
forms, including, but not limited to, emulsions, lotions, creams, ointments,
salves, suspensions, encapsulations, gels, and the like” (Lange ¶ 19).
4. Lange’s composition may further comprise solidifying agents
(including various petroleum or hydrogenated vegetable oils, silicone
polymers, and waxes); humectants “such as sugars and sugar alcohols
including mannitol, maltose, lactose, dextrose, sucrose, sorbitol, fructose,
and honey” (Lange ¶¶ 20, 40, 41).
5. According to Cornell University’s Nutritional Components in
Milk, cited by the Examiner on page 2 of the Final Rejection dated February
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16, 2011, “[m]ilk is approximately 4.9% carbohydrate in the form of
lactose” and “approximately 3.4% fat.” “The polyunsaturated fatty acids in
milk fat include small amounts of the essential fatty acids linoleic and
linolenic, and approximately 5% trans fatty acids.” In addition, milk
contains both fat-soluble and water-soluble vitamins, although the fat-
soluble vitamin content “will vary with the fat content of the product.”
6. Appellants’ Exhibit A teaches that:
Fish, plant, and nut oils are the primary dietary source of
omega-3 fatty acids. Eicosapentaenoic acid (EPA) and
docosahexaenoic acid (DHA) are found in cold-water fish such
as salmon, mackerel, halibut, sardines, tuna, and herring. ALA
is found in flaxseeds, flaxseed oil, canola (rapeseed) oil,
soybeans, soybean oil; pumpkin seeds, pumpkin seed oil;
purslane, perilla seed oil, walnuts, and walnut oil. Other
sources of omega-3 fatty acids include sea life such as krill and
algae.
(Exhibit A, p. 4 of 21.)
7. Appellants’ Exhibit B teaches that:
Nutritionally important n-3 fatty acids include α-linolenic
acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic
acid (DHA) . . . . The human body cannot synthesize n-3 fatty
acids de novo, but it can form “long chain” 20-carbon n-3 fatty
acids (like EPA) and 22-carbon n-3 fatty acids (like DHA) from
the “short chain” eighteen-carbon n-3 fatty acid α-linolenic
acid.
(Exhibit B, p. 1 of 19.)
8. Young teaches:
Milk, and cosmetic compositions containing milk, have
long been recognized as having a beneficial effect when applied
to the human skin. Moreover, whole fluid milk which still
contains its natural fats (butterfat) is regarded as more
beneficial to the skin than skim or non-fat milk and much more
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beneficial than dry milk solids or liquid milk reconstituted from
dry milk solids.
(Young, col. 1, ll. 11-17.)
9. Young discloses “[c]osmetic compositions, and in particular
cosmetic creams and lotions [which] are applied to the skin . . . to lubricate
or moisturize the skin, to alleviate or compensate for excessively dry or oily
skin, to provide a foundation for other cosmetic preparations and the like”
(Young, col. 2, ll. 56-62). According to Young:
The principal ingredient of our new cosmetic
composition is whole fluid milk containing a high proportion of
natural milk fats, and advantageously the composition is
prepared from sterilized fluid milk the milk fat content of which
has been augmented by the addition thereto of an approximately
equal amount of cream. Specifically, we have found that unless
the fluid milk contains at least about 7 percent by weight milk
fats and unless the cosmetic composition contains at least about
40 percent by weight of such milk, the composition will not
meet the emollient and lipid criteria established for our
cosmetic.
(Young, col. 3, ll. 13-24.)
DISCUSSION
The Examiner finds that Lange “discloses all aspects of the claimed
invention with the exception of the absorbent pad containing a dry milk
component” (Ans. 5). That is, the Examiner finds that Lange discloses an
absorbent pad that contains a cooling component, and “components of milk
(alpha linolenic acid, eicosapentenoic [sic] acid, docosahexonic [sic] acid,
lactose and vitamins), but does not disclose the use of dry milk to provide
these components to the absorbent pad” (id.). However, the Examiner finds
that Young teaches “the use of dry, nonfat milk in compositions intended for
application to the skin” (id. at 9).
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The Examiner concludes that it would have been obvious for one of
ordinary skill in the art “to provide the absorbent pad of [Lange] with a dry
milk component, as taught by Young, to achieve the predictable result of
providing the pad of [Lange] with the desired components (alpha linolenic
acid, eicosapentenoic [sic] acid, docosahexonic [sic] acid, lactose and
vitamins) from a single source” (id. at 5), “since Lange already contemplates
the use of certain elements of milk for use in the breast pad” (id. at 8).
Appellants contend that “[t]he Examiner erroneously alleges that milk
is a source of the omega-three fatty acids that Lange identifies” (App. Br. 8),
however, “[t]hese longer chain fatty acids, eicosapentaenoic acid and
docosahexaenoic acid, are not components of milk fat” (id. at 5), but are
synthesized “from the shorter chain alpha linolenic omega-3 fatty acid . . .
which must be obtained from food” (id. at 6), as shown in Appellants’
exhibits A and B.
Appellants further contend that Young does not teach or suggest “the
use of dry milk in their lotion as a viable alternative to whole fluid milk” (id.
at 7). Appellants contend that Lange teaches that “whole fluid milk which
still contains its natural fats (butterfat) is regarded as more beneficial to the
skin than skim or nonfat milk and much more beneficial than dry milk
solids---” (id.) (internal citation omitted), “[t]hus, Young actually teaches
away from the use of dry skim milk, or any dry milk product” (id.).
We will reverse the rejection. While we do not agree that Young goes
so far as to teach away from using dry milk in a skin care composition,
neither does it suggest using it. That is, we are not persuaded that one of
ordinary skill in the art would look to milk to provide the principal
components of Lange’s composition. An invention “composed of several
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elements is not proved obvious merely by demonstrating that each of its
elements was, independently, known in the prior art.” KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007).
First, the principal components of Lange’s composition are
eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), α-linolenic
acid, and linoleic acid (FFs 1, 2). Linoleic acid and α-linolenic acid are only
present in milk in “small amounts” (FF5), while EPA and DHA are not
present in milk at all (FFs 5, 6). In addition, while lactose is present in milk
at about 4.9% (FF5), it is merely a minor, optional component of Lange’s
composition (FF4). Therefore, the evidence of record does not support the
Examiner’s assertion that including dry milk in Lange’s composition would
“achieve the predictable result of providing the pad of [Lange] with the
desired components (alpha linolenic acid, eicosapentenoic [sic] acid,
docosahexonic [sic] acid, lactose and vitamins) from a single source” (Ans.
5).
In any case, even if one of skill in the art were inclined to use milk to
provide at least some of the components of Lange’s composition, we do not
agree that Young’s disclosure would have led one of ordinary skill in the art
to use dry milk, given Young’s clear preference for whole fluid milk (FF8).
If anything, Young’s disclosure would have led one of ordinary skill in the
art to add sterilized whole fluid milk, augmented with cream, to Lange’s
pad.
SUMMARY
The rejection of claims 1-20 under 35 U.S.C. § 103(a) as unpatentable
over Lange and Young is reversed.
REVERSED
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