Ex Parte Brusk et al

Patent Trial and Appeal Board

Jan 23, 2014

10318165 (P.T.A.B. Jan. 23, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ULLA FORSGREN-BRUSK, BO RUNEMAN,
and EVA GRAN HAKANSSON1
__________

Appeal 2012-006890
Application 10/318,165
Technology Center 1600
__________

Before DEMETRA J. MILLS, ERIC GRIMES, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a hygiene
tissue comprising probiotic bacteria, which have been rejected for
anticipation and obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 Appellants identify the Real Party in Interest as SCA Hygiene Products AB
(App. Br. 1).
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STATEMENT OF THE CASE
“The urogenital area harbors a complex microbial ecosystem
comprising . . . lactic acid producing bacteria belonging to the genus
Lactobacillus. These lactic acid producing members are important for
retaining a healthy microbial flora in these areas.” (Spec. 1, ¶ 3.) The
Specification discloses “a hygiene tissue to be used for cleaning and caring
of the skin and the urogenital area simultaneously as it delivers lactic acid
producing bacteria, thereby establishing and maintaining a healthy microbial
flora in these areas” (id. at 6, ¶ 17).
Claims 1-25 are on appeal. Claim 1 is illustrative and reads as
follows:
1. A hygiene tissue comprising:
a matrix impregnated by a composition including
a probiotic bacterial preparation of one or more lactic acid producing
bacterial strains,
encapsulated in
a lipid phase comprising one or more lipids which are all of a non-
animal origin,
wherein the probiotic bacterial preparation has a water activity of
about 0.30 or less, and the lipid phase has a water content of about 1% or
less by weight,
wherein the hygiene tissue is a device for wiping skin of a user, the
hygiene tissue being selected from the group consisting of a washcloth,
towelette and wetwipe.

Claim 11, the only other independent claim, is identical to claim 1
except that it omits the limitation that “the lipid phase has a water content of
about 1% or less by weight.”
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The claims stand rejected as follows:
• Claims 11, 12, 14, 18, 19, and 21-25 under 35 U.S.C. § 102(b) as
anticipated by Kvanta2 (Ans. 5);
• Claims 1-25 under 35 U.S.C. § 103(a) as obvious based on Kvanta
and Farmer,3 optionally combined with Conway4 (Ans. 6);
• Claims 1-25 under 35 U.S.C. § 103(a) as obvious based on
Ganeden5 and Green,6 optionally combined with Kvanta (Ans. 8);
• Claim 20 under 35 U.S.C. § 103(a) as obvious based on Kvanta,
Farmer, and Green (Ans. 9); and
• Claims 1-25 under 35 U.S.C. § 103(a) as obvious based on either
Hakansson7 or Forsgren-Brusk,8 combined with Farmer and Kvanta (Ans.
9).
I.
The Examiner has rejected claims 11, 12, 14, 18, 19, and 21-25 as
anticipated by Kvanta (Ans. 5). The Examiner finds that Kvanta “teaches
tampons or sanitary napkins impregnated with lactic acid producing
bacteria” that meet all of the limitations of the rejected claims (id.).
Appellants argue that Kvanta’s tampon and sanitary napkin “are
designed for the primary embodiment of absorbing blood, and are quite

2 Kvanta, WO 92/13577, published Aug. 20, 1992.
3 Farmer et al., US 6,716,435 B1, issued Apr. 6, 2004.
4 Conway et al., WO 00/41576, published July 20, 2000.
5 Ganeden et al., WO 01/13956 A2, published Mar. 1, 2001.
6 Green et al., US 6,365,656 B1, issued Apr. 2, 2002.
7 Hakansson et al., WO 99/45099, published Sept. 10, 1999.
8 Forsgren-Brusk et al., WO 00/35502, published June 22, 2000.
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distinct in design and application from a hygiene tissue, which is a device
for wiping skin of a user” (App. Br. 11-12).
We agree with Appellants that the Examiner has not shown that
Kvanta discloses the claimed hygiene tissue, which is expressly limited to “a
washcloth, towelette [or] wetwipe” (claim 11). The Examiner, in fact,
acknowledges that “there is a difference between a tampon and claimed
wetwipe, towelette and a washcloth” (Ans. 11) but argues that the prior art
products can be used in the same way as the claimed products.
Whether the claimed and prior art products can be used in the same
way, however, does not make them structurally identical: the question is
whether the prior art product meets all of the limitations of the claimed
product. The Examiner has acknowledged that the prior art products differ
from the claimed products; therefore, the claimed products are not
anticipated by Kvanta. The rejection under 35 U.S.C. § 102(b) is reversed.
II.
Issue
The Examiner has rejected claims 1-25 as obvious based on Kvanta
and Farmer (Ans. 6).9 The Examiner finds that Kvanta “teaches tampons or
sanitary napkins impregnated with lactic acid producing bacteria . . .
suspended in vegetable oil or coco fat” (id.). The Examiner reasons that
“since the bacterial preparation is added in the form of powder or the
composition is freeze-dried, it is the examiner’s position that it would have

9 The Examiner alternatively based the rejection on Kvanta, Farmer, and
Conway (Ans. 6). Because we conclude that Kvanta and Farmer support a
prima facie case of obviousness, we will not further discuss Conway.
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less than [the] claimed water activity” (id.). The Examiner finds that Farmer
discloses lactic acid producing bacteria in a variety of products, including
sanitary napkins, towelettes, and washcloths (id. at 7), and concludes that it
would have been obvious to apply Kvanta’s compositions to towelettes and
washcloths “since Farmer teaches that lactic acid producing bacteria could
be applied to sanitary articles such as sanitary napkins, towelettes, baby
wipes and washcloth[s]” (id.).
Appellants contend that “[f]reeze-drying a bactericidal [sic, bacterial]
preparation does not result in a set water activity value” (App. Br. 16).
Appellants cite a research paper as evidence that freeze-dried bacteria can
have a water activity of 0.23 or 0.43 (id. at 14, 16).10 Appellants also argue
that “the Examiner has presented no evidence of a process that can produce
freeze-dried bacteria with a water activity of 0.30 or less at the time of the
appellants’ invention” (id. at 19). Appellants also argue that the Examiner
has not provided evidence to show that those skilled in the art recognized the
claimed water activity level as beneficial, or that water activity was a result-
effective variable, and therefore would have had no reason to “freeze-dry in
a manner to obtain the claimed water activity level” (id. at 18-19).
Appellants also argue that Kvanta does not teach an oil having a water
content of less than 1% by weight (Reply Br. 5). Finally, Appellants argue

10 The cited paper is Kurtmann et al., Water Activity-Temperature State
Diagrams of Freeze-Dried Lactobacillus acidophilus (La-5): Influence of
Physical State on Bacterial Survival during Storage, 25 BIOTECHNOL. PROG.
265-270 (2009). Although Appellants argue that “the Examiner relies upon”
this post-filing date reference, Kurtmann was submitted and relied upon by
Appellants in their submission filed Jan. 18, 2011.
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that “there is no specific reason to use the precise probiotic composition of
[Kvanta] on a hygiene tissue” (App. Br. 20).
The issues with respect to this rejection are whether the evidence
supports the Examiner’s position that the composition of freeze-dried
bacteria in vegetable oil disclosed by Kvanta would have the properties
recited in claim 1, and whether the evidence supports the Examiner’s
conclusion that it would have been obvious to combine Kvanta’s
composition with the towelettes, wipes, or washcloths suggested by Farmer.
Findings of Fact
1. Kvanta discloses “the production and use of a tampon or sanitary
napkin being impregnated with a culture of living lactic acid producing
bacteria” (Kvanta 1:5-7).
2. Kvanta discloses that suitable lactic acid producing bacteria
“belong to the genera Pediococcus, Lactobacillus, but also Leuconostoc” (id.
at 5:30-31).
3. Kvanta discloses that the “lactic acid producing bacteria are . . .
cultivated in a fermentor in a manner known per se, are separated from the
medium using a separator or a centrifuge, are freeze-dried in a manner
known per se, and ground to a fine powder” (id. at 6:11-14).
4. Kvanta discloses that “[t]he powderous bacterial concentrate thus
obtained is then mixed with a fermentable carbohydrate” and added to a
tampon or sanitary napkin (id. at 6:15-20).
5. Kvanta discloses that the
addition of the bacterial powder on a tampon or sanitary napkin
can suitably be carried out in two ways. . . . According to the
second method the desired amount of bacterial powder is
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applied in the form of a suspension wherein the bacterial
powder is finely distributed in the adhesive agent to a
homogeneous suspension. The application can take place e.g.
by coating of the suspension or by dipping the tampon in the
suspension.
(Id. at 6:24 to 7:7.)
6. Kvanta discloses that suitable adhesive agents include “coco fat,
vegetabilic [sic] oil, or other glyceride or wax or any other compound having
the similar properties and a good skin and mucous membrane tolerance” (id.
at 4:32-34).
7. Farmer discloses “compositions of a probiotic acid bacteria,
preferably a lactic acid bacteria, . . . applied to a solid surface or
impregnated into a solid matrix of any device or article of manufacture that
is intended to be in contact with skin or a mucous membrane” (Farmer,
col. 15, ll. 54-59).
8. Farmer discloses that “[p]referably the solid surface is a flexible
article than can be worn on or wiped on the skin or mucous membrane” (id.
at col. 15, ll. 60-61).
9. Farmer discloses that suitable articles “include diapers, towelettes
(e.g., baby wipes or feminine hygiene towelettes), sanitary napkins,
tampons, . . . wash cloths [sic], and the like” (id. at col. 16, ll. 2-9).
10. Appellants’ Specification states that the “preparation of lactic
acid producing bacteria are preferably in a dried form, preferably as a freeze-
dried powder. . . . Preferably, the water activity of the bacterial preparation
is about 0.30 or less.” (Spec. 11 ¶ 46).
11. Appellants’ Specification includes a working example that states:
“A preparation of freeze dried L. plantarum 931 cells in skim[ ]milk was
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ground until a powder of fine grains was formed. 10 g of the L. plantarum
931 powder was added to 120 ml olive oil (Filippo BERIO® extra virgin
olive oil) and shaken until a homogenous solution was formed.” (Id. at 14,
¶ 56.)
12. The working example states that the viability of the cells was
tested after storage for three months and one year, and the “survival of the L.
plantarum 931 cells stored under these conditions was very high” (id. at 16,
¶ 59).
13. Kurtmann11 states that “[t]o ensure a long-term delivery of active
bacteria upon rehydration, starter cultures and probiotics are commonly
freeze-dried for storage and distribution” (Kurtmann 265, left col.).
14. Kurtmann states that the “viability of freeze-dried bacteria is
known to depend on a number of conditions such as . . . subsequent storage
conditions including temperature, water activity, and atmosphere” (id.).
15. Kurtmann states that preparations of Lactobacillus acidophilus
were freeze-dried and that “[a]fter freeze drying, the water activity of the
dried samples was below the detection limit (0.037), and they were stored at
-40°C in sealed metallized bags until further use” (id. at 266, left col.).
16. Kurtmann states that “bacteria cultures were placed in glass
desiccators with saturated salt solutions in the bottom of the desiccators with
aw [water activity] 0.11 (LiCl), 0.23 (CH3COOK), and 0.43 (K2CO3) and
stored at 20°C for a period of 10 weeks” (id. at 266, right col.).

11 See note 10 above.
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Principles of Law
Where . . . the claimed and prior art products are identical or
substantially identical . . . the PTO can require an applicant to
prove that the prior art products do not necessarily or inherently
possess the characteristics of his claimed product. Whether the
rejection is based on “inherency” under 35 U.S.C. § 102, on
“prima facie obviousness” under 35 U.S.C. § 103, jointly or
alternatively, the burden of proof is the same, and its fairness is
evidenced by the PTO’s inability to manufacture products or to
obtain and compare prior art products.
In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (citations and footnote
omitted).
Analysis
Kvanta discloses tampons or sanitary napkins (FF 1) coated with a
composition comprising freeze-dried lactic acid-producing bacteria (FF 3)
distributed in an adhesive agent (FF 5) such as vegetable oil (FF 6). Farmer
discloses applying lactic acid bacteria (FF 7) to articles that can be wiped on
the skin or mucous membranes (FF 8), including tampons, sanitary napkins,
washcloths, towelettes, and wipes (FF 9). We agree with the Examiner that
it would have been obvious to apply Kvanta’s bacteria-and-oil composition
to a washcloth, towelette, or wet wipe in view of Farmer’s express
suggestion to apply a composition containing lactic acid bacteria to such
articles.
We also agree with the Examiner that it is reasonable to conclude that
Kvanta’s freeze-dried bacteria preparation would inherently have a water
activity of 0.30 or less. Appellants’ Specification itself supports this
conclusion, because it states that the bacterial preparation preferably has a
water activity of 0.30 or less, and is preferably freeze-dried (FF 10). The
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Specification also provides a working example in which the bacterial
preparation used is described as “freeze dried L. plantarum 931 cells in
skim[ ]milk” (FF 11). Finally, Kurtmann discloses that after freeze-drying,
the water activity of L. acidophilus samples was below 0.037 (FF 15).
Based on these pieces of evidence, it is reasonable to conclude that Kvanta’s
freeze-dried bacteria would inherently have a water activity of 0.30 or less.
Appellants have provided no evidence that supports a contrary conclusion.
Appellants’ argument that Kurtmann provides evidence that freeze-
dried bacteria can have a water activity of 0.23 or 0.43 (App. Br. 16) is not
persuasive. Kurtmann discloses that, after freeze-drying, a bacterial
preparation had a water activity below the detection limit of 0.037 (FF 15).
Kurtmann discloses that the higher water activities (e.g., 0.23 or 0.43) were
obtained by storing the freeze-dried bacteria with saturated salt solutions (FF
16), not by freeze-drying under different conditions.
Appellants’ argument that the Examiner has not shown that those
skilled in the art recognized a low water activity level as beneficial, or
recognized water activity as a result-effective variable (App. Br. 18), and
therefore would not have had a reason to freeze-dry so as to achieve the
claimed water activity level (id. at 19), is also unpersuasive. As discussed
above, the evidence of record supports the conclusion that freeze-dried
bacteria, like those disclosed by Kvanta, inherently have a water activity of
less than 0.30.
Appellants also argue that the Examiner has not shown evidence that a
freeze-drying process was known in the art, as of the instant application’s
filing date, that could produce a water activity of 0.30 or less (id.). This
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argument is not persuasive because it is contradicted by Appellants’ own
Specification, which states without elaborating that “freeze-dried” bacteria
are preferably used to achieve the preferred water activity of 0.30 or less (FF
10) and the working example’s description of the bacteria used simply as
“freeze dried” (FF 11). The Specification therefore provides evidence that
no special freeze-drying process is required to achieve the claimed water
activity.
Appellants also argue that “there is no specific reason to use the
precise probiotic composition of [Kvanta] on a hygiene tissue” (App. Br.
20). This argument is not persuasive because both Kvanta and Farmer
disclose compositions of lactic acid-producing bacteria (FF 1, FF 7), Kvanta
discloses applying the composition to tampons or sanitary napkins (FF 1),
and Farmer discloses applying the composition to articles that can be worn
or wiped on the skin or mucous membranes (FF 8), including not only
tampons and sanitary napkins, but also towelettes, wipes, and washcloths
(FF 9). Farmer’s disclosure of towelettes, wipes, and washcloths as suitable
for coating with lactic acid-producing bacteria compositions would have
suggested, to a person of ordinary skill in the art, expanding the breadth of
articles used with Kvanta’s composition to include towelettes, wipes, and
washcloths.
Finally, Appellants argue that Kvanta does not disclose an oil having a
water content of less than 1% by weight (Reply Br. 5). Kvanta, however,
discloses that vegetable oil (or “vegetabilic oil”) is a suitable adhesive for
use in its composition (FF 6). The Specification’s Example 1 uses
commercially obtained olive oil as the lipid phase (FF 11), and does not
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describe any procedures undertaken to modify the olive oil to have a water
content below 1% by weight. The evidence is therefore sufficient to support
concluding that commercially available vegetable oil, such as olive oil,
meets the claim limitation of having less than 1% water by weight.
Appellants have provided no evidence to the contrary.
Conclusion of Law
The evidence supports the Examiner’s position that the composition
of freeze-dried bacteria in vegetable oil disclosed by Kvanta would have the
properties recited in claim 1. The evidence also supports the Examiner’s
conclusion that it would have been obvious to combine Kvanta’s
composition with the towelettes, wipes, or washcloths suggested by Farmer.
Claims 2-25 have not been argued separately and therefore fall with
claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
III.
The Examiner has rejected claims 1-25 under 35 U.S.C. § 103(a) as
obvious based on Ganeden and Green, optionally combined with Kvanta
(Ans. 8). The Examiner finds that Ganeden discloses “articles . . .
includ[ing] pliable material for wiping skin or an absorbent pad or tampon”
(id.) and Green “disclos[es] personal care products containing oils [and]
teaches the equivalency between Emu oil and oils such as soybean oil,
coconut oil and peanut oil” (id.). The Examiner concludes that “[t]he use of
an oil such as soybean oil instead of Emu oil taught by [Ganeden] would
have been obvious to one of ordinary skill in the art since Green teaches not
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only the equivalency between these two oils and also its superiority in terms
of spreading properties and emolliency characteristics” (id.).
Appellants argue that Ganeden “specifically teaches and relies upon
the different results obtained with Emu oil” and that substituting soybean oil
in Ganeden’s invention would require “one skilled in the art to simply ignore
the entire disclosure” of Ganeden (App. Br. 26-27).
We agree with Appellants that the Examiner has not provided a
persuasive reason for modifying Ganeden to substitute soybean oil for Emu
Oil. Ganeden states that its invention “relates to compositions and methods
of use of Emu Oil . . . in combination with appropriate medicaments, in the
treatment of bacterial, fungal, and viral infections of the dermis and cuticle”
(Ganeden 1:13-15). Ganeden discloses that Emu Oil has several specific
properties that enhance its usefulness in therapeutic compositions (see id. at
3:8 to 6:18). Although Green discloses that both emu oil and soybean oil are
useful in liquid dispersion polymer compositions (Green, col. 6, ll. 24-39),
the Examiner has not provided a persuasive reason for concluding that it
would have been obvious to replace the Emu Oil that is an integral part of
Ganeden’s invention with soybean oil, which has not been shown to have
any of the beneficial properties emphasized by Ganeden. We therefore
reverse the rejection of claims 1-25 based on Ganeden, Green, and Kvanta.
IV.
Issue
The Examiner has rejected claim 20 under 35 U.S.C. § 103(a) as
obvious based on Kvanta, Farmer, and Green (Ans. 9). Kvanta and Farmer
are discussed above. The Examiner finds that Green “teaches several
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vegetable oils and superior properties of soy bean oil” (id.) and concludes
that it would have been obvious to use soybean oil in Kvanta’s composition
based on Green’s disclosure that it “contain high levels of oleic and linoleic
fatty acids and their presence gives good spreading properties with superior
emolliency characteristics” (id.).
We agree with the Examiner that soybean oil would have been an
obvious choice for use in Kvanta’s composition. Kvanta suggests vegetable
oils generally (FF 6) and Green provides evidence that soybean oil was
among the known types of vegetable oil (Green, col. 6, ll. 34-39). Green
also provides reason to use soybean oil specifically, since it is disclosed to
provide “superior emolliency characteristics compared to mineral oil” (id. at
col. 6, l. 52) and increased skin moisturization (id. at col. 6, l. 55).
Appellants repeat their arguments regarding water activity levels
(App. Br. 40-41) and motivation to combine Kvanta and Farmer (id. at 43).
These arguments have been addressed above.
Appellants also argue that Green’s “alleged teachings do not remedy
the deficiencies of [Kvanta] with regard to the claimed water activity” (id. at
42). For the reasons discussed above, however, we conclude that Kvanta is
not deficient with regard to the claimed water activity.
We affirm the rejection of claim 20 under 35 U.S.C. § 103(a) based on
Kvanta, Farmer, and Green.
V.
The Examiner has rejected claims 1-25 under 35 U.S.C. § 103(a) as
obvious based on either Hakansson or Forsgren-Brusk, combined with
Farmer and Kvanta (Ans. 9). We have already concluded that claim 1 would
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have been obvious based on Kvanta and Farmer. We therefore affirm the
rejection of claim 1 as obvious based on either Hakansson or Forsgren-
Brusk, combined with Farmer and Kvanta for the reasons discussed in detail
above. Claims 2-25 fall with claim 1 because they were not argued
separately. 37 C.F.R. § 41.37(c)(1)(vii).
Appellants repeat their arguments based on water activity level and
motivation to combine Kvanta’s composition with the articles disclosed by
Farmer (App. Br. 33-39). These arguments have been addressed above.
SUMMARY
We reverse the rejection of claims 11, 12, 14, 18, 19, and 21-25 as
anticipated by Kvanta, and the rejection of claims 1-25 as obvious based on
Ganeden and Green, optionally combined with Kvanta.
We affirm the rejection of claims 1-25 under 35 U.S.C. § 103(a) as
obvious based in Kvanta and Farmer; the rejection of claim 20 as obvious
based on Kvanta, Farmer, and Green; and the rejection of claims 1-25 as
obvious based on either Hakansson or Forsgren-Brusk, combined with
Farmer and Kvanta.
TIME PERIOD FOR RESPONSE
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

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