Ex Parte Neubourg

Patent Trial and Appeal Board

Dec 18, 2018

12664732 (P.T.A.B. Dec. 18, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/664,732 12/15/2009 Thomas Neubourg
27774 7590 12/20/2018
MA YER & WILLIAMS PC
55 Madison A venue
Suite 400
Morristown, NJ 07960
UNITED ST A TES OF AMERICA
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
7003/156 4603
EXAMINER
KISHORE, GOLLAMUDI S
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
12/20/2018 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
docket@mwpatentlaw.com
mwolf@mwpatentlaw.com
kwilliams@mwpatentlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte THOMAS NEUBOURG
Appeal2017-008850
Application 12/664,732
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1,2 under 35 U.S.C. § 134 involving claims to
cosmetic and dermatologic foam formulations. The Examiner rejected the
claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b ). We affirm.
Statement of the Case
Background
"In an emulsion, one of both liquids is dispersed in the other liquid in
the form of fine droplets" (Spec. 1 ). "Emulsions represent an important type
1 Appellant identifies the Real Party in Interest as Neubourg Skin
Care GmbH & Co. KG. (Br. 1).
2 We have considered and herein refer to the Specification of Dec. 15, 2009
("Spec."); Final Office Action of Feb. 22, 2016 ("Final Act."); Appeal Brief
of Jan. 26, 2017 ("Br."); and Examiner's Answer of Mar. 17, 2017 ("Ans.").
Appeal2017-008850
Application 12/664,732
of product in the field of cosmetic and/or dermatologic preparations ... for
skin care, especially for relubricating dry skin," "as deodorants," and "for
cleaning of the skin" (id. at 3). "Emulsifiers were used as adjuvants for the
manufacture and especially for stabilizing emulsions" (id.). However,
"emulsifiers may also lead to irritations or may even cause allergies in case
of sensitive skin" (id. at 6). "Omission of conventional emulsifiers
prevents" formation of "micelles or vesicles ... so that the lamellar structure
of the formed membrane is maintained in the emulsion" (id. at 7).
The Specification teaches "that emulsions comprising an oil phase and
a water phase wherein the oil phase comprises at least one membrane-
forming substance forming a lamellar membrane in the foam formulation are
suitable as basis for foam formulations" (Spec. 8).
The Claims
Claims 1, 3, 4, 7-13, 17, 18, 22-24, and 28-35 are on appeal. Claim
1 is the sole independent claim, is representative and reads as follows:
1. A foam comprising:
a water phase, a lamellar membrane phase, and a
propellant;
wherein the lamellar membrane phase comprises
hydrogenated lecithin in the form of lamellar membrane
structures and an oil, wherein the foam is produced by a method
compnsmg:
providing a water phase;
providing an oil and a hydrogenated lecithin;
mixing the water phase, the oil, and the hydrogenated
lecithin by applying ultrasound or by high pressure
homogenization at a pressure of about 50,000 kilopascal to
about 250,000 kilopascal, below the phase transition
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temperature of the hydrogenated lecithin, to obtain a mixture
containing a water phase and a lamellar membrane phase;
combining the mixture containing water phase and
lamellar membrane phase with a propellant to obtain a mixture
containing water phase, lamellar membrane phase, and
propellant; and
dispensing the mixture containing water phase, lamellar
membrane phase and propellant from a pressurized container to
obtain the foam.
The Rejections
A. The Examiner rejected claims 1, 3, 4, 7-13, 17, 18, 22-24, 28-31, and
33-35 under 35 U.S.C. § I03(a) as being obvious over Popp3 and Goldberg
'2104 (Final Act. 2--4).
B. The Examiner rejected claims 1, 3, 4, 7-13, 17, 18, 22-24, 28-31, and
33-35 under 35 U.S.C. § I03(a) as being obvious over Popp, Goldberg '210,
and Arata5 (Final Act. 4--5).
C. The Examiner rejected claims 1, 3, 4, 7-13, 17, 18, 22-24, 28-31, and
33-35 under 35 U.S.C. § I03(a) as being obvious over Chang, 6 Yasuhiro,7
Simonnet, 8 Goldberg '210, Guo,9 and Edgar10 (Final Act. 5-7).
3 Popp et al., US 2006/0029657 Al, published Feb. 9, 2006.
4 Goldberg et al., US 2003/0083210 Al, published May 1, 2003.
5 Arata et al., US 2006/0115440 Al, published June 1, 2006.
6 Chang et al., US 5,120,528, issued June 9, 1992.
7 Yasuhiro et al., JP 2004/331610 A, Nov. 25, 2004. Because this Japanese
publication has the application number 2003-132038, we understand the
Examiner's reference to "JP2003/0I32038" as drawn to this publication.
8 Simonnet et al., US 6,342,238 Bl, issued Jan. 29, 2002.
9 Guo, US 4,818,537, issued Apr. 4, 1989.
10 Edgar et al., US 5,498,420, issued Mar. 12, 1996.
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D. The Examiner rejected claims 1, 3, 4, 7-13, 17, 18, 22-24, 28-31, and
33-35 under 35 U.S.C. § I03(a) as being obvious over Friedman, 11
Simonnet, and Goldberg '210 (Final Act. 7-10).
E. The Examiner rejected claims 1, 3, 4, 7-13, 17, 18, 22-24, 28-31, and
33-35 under 35 U.S.C. § I03(a) as being obvious over Goldberg '968, 12
Chang, and Simonnet (Final Act. 10-11).
F. The Examiner rejected claims 1, 3, 4, 7-13, 17, 18, 22-24, 28-31, and
33-35 under 35 U.S.C. § I03(a) as being obvious over Chang, Popp,
Lanzendorfer, 13 and Goldberg '210 (Final Act. 11-13).
A. 35 US.C. § 103(a) over Popp and Goldberg '210
The Examiner finds "Popp teaches topical foam oil in water emulsion
formulations containing ceramide 3 and triglycerides. The compositions
further contain hydrogenated lecithin and pentylene glycol, Xanthan gum
and antibiotics; the composition in Popp is homogenized" (Final Act. 3).
The Examiner acknowledges "Popp does not teach the preparation with a
propellant" (id.). The Examiner finds Goldberg teaches "the inclusion of
propellant to generate the foam" (id.). The Examiner finds it obvious to
"include a propellant in the emulsion formulations of Popp in order to obtain
a product which forms a foam upon the application" (id.).
11 Friedman et al., US 2005/0244342 Al, published Nov. 3, 2005.
12 Goldberg et al., WO 03/017968 A2, published Mar. 6, 2003.
13 Lanzendorfer et al., US 7,052,716 Bl, issued May 30, 2006.
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With regard to all the rejections on appeal, Appellant contends that:
• The Examiner erred in claim construction.
• The Examiner erred by discounting or not properly
considering the evidence provided by Appellant.
• The Examiner erred by not considering Appellant's arguments
showing the differences between the cited references and the
claimed invention.
• The Examiner erred by taking improper official notice.
• The Examiner erred by misinterpreting Applicant's disclosure.
• The Examiner erred by not considering whether there is any
reasonable expectation of success in arriving at the claimed
invention even after Appellant explained the differences
between prior art and the claimed invention.
(Br. 3).
The issue with respect to obviousness is: Does the evidence of record
support the Examiner's conclusion that Popp and Goldberg render the claims
obvious?
Findings of Fact
1. Popp teaches:
a therapeutically effective amount of a skin protectant
composition comprising: a) a ceramide, b) a squalane, c) a
phytosterol-containing liposome, d) a phospholipid-containing
ingredient, e) at least one triglyceride, and f) at least one
dermatologically acceptable excipient; and a carrier for said
skin protectant composition, wherein said skin protectant
composition is free of cholesterol.
(Popp ,r,r 31-38; internal paragraph numbers omitted).
2. Popp teaches "the term a 'liposome' refers to a completely
closed bilayer membrane containing an encapsulated aqueous phase.
Liposomes may be any variety of multilamellar vesicles or unilamellar
vesicles or structures" (Popp ,r 125).
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3. Popp teaches the "'aerosol' dosage form described herein is
synonymous with a 'foam' dosage form, referring to a coarse dispersion of
gas in liquid in which the volume of the gas is considerably larger than that
of the liquid" (Popp ,r 119).
4. Popp teaches a "preferred, non-limiting phospholipid-
containing ingredient useful in the present compositions is hydrogenated
lecithin" (Popp ,r 160).
5. Popp teaches that after an emulsion is formed:
Ceramide-3 and the Hydrogenated Lecithin are then added to
the emulsion while stirring at about 3 0 rpm. While stirring at
about 30 rpm, the emulsion is homogenized at about 3000 rpm
for about 55 minutes at a temperature of not more than 34 ° C.
Once all large solid agglomerates have been removed, the
emulsion is cooled to 25-27° C. while stirring at about 30 rpm.
(Popp i1229).
6. Goldberg '210 teaches "self-foaming lamellar compositions,
and ... aerosol barrier dispensing systems to dispense the self-foaming
lamellar compositions" (Goldberg '210 ,r 2).
7. Goldberg '210 teaches the "lamellar phase, for example,
consists of alternating surfactant bilayers and water layers. These layers are
not generally flat but fold to form submicron spherical onion like structures
called vesicles or liposomes" ( Goldberg '210 ,r 41 ).
8. Goldberg '210 teaches the "neat cleansing lotion is a lamellar
structured shear thinning composition at 25 C; and wherein the cleansing
composition is contained in an aerosol pressurized piston container
having an aerosol propellant" (Goldberg '210 ,r 14).
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9. Goldberg '210 teaches a
liquid cleansing and moisturizing composition comprising:
(a) from about 80 to about 97 % by wt. of a neat cleansing
lotion having
about 0.5 to about 65%, preferably 1 to about
25% by wt. of the total composition of at least one non-soap
anionic or mixture of non-soap anionic surfactants;
about 35 to about 90% by wt. of the total composition of
water;
(b) from about 3 to about 20% by wt. of the total composition
of at least one volatile foaming agent, preferably having at least
one or more hydrocarbons or mixture thereof; and
wherein the neat cleansing lotion is a lamellar
structuredshear thinning composition at 25 C.
( Goldberg '210 ,r,r 23-28; internal paragraph numbers omitted).
10. Goldberg '210 teaches the composition may include emollients
such as ceramides and phospholipids (Goldberg '210 ,r,r 114, 117).
11. Goldberg '210 teaches multiple mixing steps to formulte the
base at elevated temperatures (see Goldberg '210 ,r 209, table 7).
12. Goldberg '210 teaches the "generation of a foam provides a
product which has various desirable consumer attributes, including ease of
handling and spreading, and desirable sensory properties" (Goldberg '210
i1 124).
Principles of Law
"An essential purpose of patent examination is to fashion claims that
are precise, clear, correct, and unambiguous. Only in this way can
uncertainties of claim scope be removed, as much as possible, during the
administrative process." In re Zietz, 893 F.2d 319,322 (Fed. Cir. 1989).
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"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007).
Analysis
We adopt the Examiner's findings of fact and conclusions of law (see
Final Act. 2--4; FF 1-10) and agree that the combination of Popp and
Goldberg renders the claims obvious. We address Appellant's arguments
below.
We begin with claim interpretation, because before a claim is properly
interpreted, its scope cannot be compared to the prior art. The limitation in
dispute is the requirement for a "lamellar membrane phase" as required by
claim 1 (see Br. 7, Ans. 10).
Appellant does not identify a definition for "lamellar membrane
phase" in the Specification, but rather contends "the specification makes it
abundantly clear that the lamellar structure of the claimed invention is not
the same as liposomal structure" (Br. 6).
The Specification does not provide an express definition for "lamellar
membrane phase." The Specification teaches that "the use of emulsifiers
normally results in the conversion of lamellar structures of the lipid barrier
into vesicular structures such as e.g. micelles or mixed micelles" (Spec. 3).
The Specification explains that the "capacity of a membrane-forming
substance to form lamellar structures as opposed to micelles depends,
however, in particular on the optimal area and/or (boundary surface
carbon/water), the volume V and the critical chain length le'' (Spec. 5). The
Specification concludes that "[ o ]mission of conventional emulsifiers
prevents ... micelles or vesicles [ from being] formed so that the lamellar
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Application 12/664,732
structure of the formed membrane is maintained in the emulsion. This
lamellar structure is based on the (physical) structure and the ( chemical)
composition of the natural epidermal skin lipids that are preferably present"
(Spec. 7).
The Specification distinguishes between lamellar structures and
micelles, but does not directly discuss liposomes. We note that a micelle is
defined as: "A spherical structure in which the hydrophobic portions of
amphipathic molecules such as phospholipids are inwardly directed, with
only hydrophilic portions in contact with the surrounding aqueous phase." 14
In contrast, a liposome is defined as: "Single- or multilayered spherical lipid
bilayer structures produced from lipids dissolved in organic solvents and
then dispersed in aqueous media." 15 These terms may be visually compared
using the images from Figure 4 of the Daniels Declaration 2016, 16
reproduced below:
14 See http://www.oxfordreference.com/view/10.1093/acref/978019
9549351.001.0001/acref-9780199549351-e-6000?rskey=A WM9id&result=4
(accessed Dec. 10, 2018).
15 See http://www.oxfordreference.com/view/10.1093/acref/978019
9549351.001.0001/acref-9780199549351-e-5496?rskey=eatU8v&result=l 7
(accessed Dec. 10, 2018).
16 Declaration of Dr. Rolf Daniels, dated Jan. 18, 2016.
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'.·, .. · .. · ....... , .·. ······ .. . ....... .. · .. · .. · ... · ' '• .·.·.:- .. ·.:· .. ·.·. ·. · .. •' ... • .. · ....
-:-::-:->:-:~:-.:-.::·>:<: ·.>:~:-:-:--.:-:<:-.>.>-.>:-:· >>:"·>>· .. · ~ .. ·.-
~ 11~1111:i !
We note that the definition of "phospholipid bilayer," identified as the
structure of a liposome in the Daniels Declaration 2016 image reproduced
above, is defined as: "A lamellar organization (lamellar phase) of
phospholipids packed as a bilayer -7 nm thick with the hydrophobic acyl
tails inwardly directed and polar head groups on the outside surface." 17
While the Specification teaches that micelles are not within the scope of
lamellar structures, the Specification does not state, explicitly or implicitly,
that liposomes are not a "lamellar membrane phase." Meanwhile, the
Daniels Declaration 2016 identifies liposomes as composed of a
phospholipid bilayer membrane that is definitionally a "lamellar phase" (see
Daniels Deel. 2016, Fig. 4). Therefore, the issue becomes whether the
ordinary understanding of a "lamellar membrane phase" encompasses
liposomes.
Popp teaches that "[l]iposomes may be any variety of multilamellar
vesicles or unilamellar vesicles or structures" (FF 2). Goldberg teaches "the
"lamellar phase, for example, consists of alternating surfactant bilayers and
water layers. These layers are not generally flat but fold to form submicron
17 See http://www.oxfordreforence.com/view/10.1093/oi/authority.
20110803100324150?rskev=Sua2JF&result=3 (accessed Dec. 10, 2018).
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spherical onion like structures called vesicles or liposomes" (FF 7).
Thus, both of the cited prior art references, Popp and Goldberg,
expressly state that liposomes are lamellar phase structures (FF 2, 7),
consistent with the definition of phospholipid bilayer that composes
liposomes as discussed above. The ordinary understanding is that liposomes
are composed of a "lamellar membrane phase" consistent with the
phospholipid bilayer nature of liposomes.
We have considered the Daniels Declaration 2015, 18 and the Daniels
Declaration 2016, but in neither Declaration does Dr. Daniels provide a
definition of the term "lamellar membrane phase" based on the Specification
or prior art. Dr. Daniels does not state that liposomes are not lamellar or that
liposomes cannot be considered a "lamellar membrane phase," and does not
address the express teachings of both Popp and Goldberg that liposomes are
a lamellar phase (FF 2, 7). Instead, in his 2016 Declaration, Dr. Daniels
states that Figure 4B "illustrates the lamellar membrane phase, where
hydrogenated lecithin is in the form of lamellar membrane structures, which
is distinct from a liposomal phase and wherein the bilayer membranes form
flat stacks of bilayer membranes dispersed in the continuous water phase"
(Daniels Deel. 2016 ,r 9). Similarly, in his 2015 Declaration, Dr. Daniels
states the invention provides "stable, sheet-like lamellar membranes (i.e.,
without the presence of liposomes or micelles)" (Daniels Deel. 2015 ,r 8).
We find that neither declaration provides a sufficient basis to exclude
liposomes from the scope of "lamellar membrane phase."
18 Declaration of Dr. Rolf Daniels, dated May 9, 2015.
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Therefore, we determine that the broadest reasonable interpretation of
the phrase "lamellar membrane phase" in light of the Specification, the prior
art, and the two Daniels' Declarations includes liposomes." 19
Appellant contends "the Examiner makes a mere, unsupported
assertion that liposomes are lamellar membrane structures; he has failed to
provide any reliable evidence to back up this assertion. The Examiner is
taking improper official notice" (Br. 7-8).
We are not persuaded. This request for a § 104( d) (2) affidavit or a
declaration by the Examiner is inapposite because the Examiner is relying
not on personal knowledge, but rather on the teachings of the cited
references, Popp and Goldberg. As already noted, Popp states that
"[l]iposomes may be any variety of multilamellar vesicles or unilamellar
vesicles or structures" (FF 2), while Goldberg teaches "the "lamellar phase,
for example, consists of alternating surfactant bilayers and water layers.
These layers are not generally flat but fold to form submicron spherical
onion like structures called vesicles or liposomes" (FF 7).
Therefore, the interpretation of "lamellar membrane phase" as
encompassing liposomes is supported by the disclosures of two US patent
publications, which the examiner is entitled to rely upon "without
conducting an inquiry into whether or not that prior art reference is
19 We note that Appellant introduced a limitation of "substantially free of
liposomal structures" in an Amendment filed May 11, 2015, but in light of
the Examiner's rejection of the limitation as new matter in the Non-Final
Action mailed July 16, 2015, Appellant removed this language in an
Amendment filed January 19, 2016. This prosecution history, therefore, also
supports our conclusion that the current claim does not exclude lamellar
structures including liposomes.
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enabling." In re Antor Media Corp., 689 F.3d 1282, 1289 (Fed. Cir. 2012).
Rather, "the burden shifts to the applicant to submit rebuttal evidence of
nonenablement." Id. In this case, Appellant has not provided persuasive
evidence that the understanding of Popp and Goldberg that liposomes are a
type of "lamellar membrane phase" is incorrect.
Appellant also contends "under the high energy input conditions
applied below the phase transition temperature of hydrogenated lecithin, in
accordance with the claimed invention, e.g., high pressure homogenization,
hydrogenated lecithin forms lamellar membrane structures, which are
distinctly different from the liposomal structures referred to by Popp" (Br.
5).
We find this argument unpersuasive for two reasons. First, in light of
our claim interpretation above, claim 1 does not exclude the presence of
liposomes as a "lamellar membrane phase" within the foam. Claim 1, which
uses the open-ended "comprising" language, simply requires three structural
components: a water (i.e., aqueous) phase taught by Popp (FF 2), a lamellar
membrane phase such as a liposome taught by Popp (FF 2), and a propellant
sufficient to form a foam as taught by Goldberg '210 (FF 8) with a lamellar
phase (FF 6-7). The prior art reasonably suggests a foam within the scope
of the language of claim 1. See Georgia-Pacific Corp. v. US. Gypsum Co.,
195 F.3d 1322, 1327 (Fed. Cir. 1999) (The transitional term "comprising" is
"inclusive or open-ended and does not exclude additional, unrecited
elements or method steps.")
Second, Appellant provides limited and unpersuasive evidence that
the process results in a structurally different composition from that rendered
obvious by Popp and Goldberg '210. Generally, the patentability of
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product-by-process claims does not depend upon process limitations recited
in the claims. See In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985) ("even
though product-by-process claims are limited by and defined by the process,
determination of patentability is based on the product itself;" "[t]he
patentability of a product does not depend on its method of production;" and
"[i]f the product in a product-by-process claim is the same as or obvious
from a product of the prior art, the claim is unpatentable even though the
prior product was made by a different process.") Appellant does not directly
compare the claimed product to the lamellar foam of Goldberg '210, for
example, which contains water, a lamellar phase, and a propellant (FF 7-8)
and which is formed by high temperature mixing (FF 11 ). Therefore,
Appellant has not established that the product differs structurally from the
prior art.
Claim 35
Appellant contends that "[ c ]laim 3 5 is patentable over the
combinations of cited references because there is no suggestion in the cited
references on how to achieve a lamellar membrane structure, and even if
there is any suggestion, arguendo, there is no reasonable expectation of
success" (Br. 17).
We are not persuaded by this argument because claim 35 is drawn
solely to a product composed of a water phase, a lamellar membrane phase,
a propellant, and an oil, and for the reasons already discussed above, the
liposomes disclosed by the prior art are reasonably considered to satisfy the
"lamellar membrane phase" recited in claim 35. This same reasoning
applies to claim 35 with regard to the rejections that follow.
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Conclusion of Law
The evidence of record supports the Examiner's conclusion that Popp
and Goldberg render the claims obvious.
B. 35 USC§ 103(a) over Popp, Goldberg '210, and Arata
Appellant contends
the combination of Popp and Goldberg fail to suggest the
present claims. Further, as submitted by Appellant, Arata fails
to cure the deficiencies of the combination of Popp and
Goldberg, namely, it fails to disclose or suggest a composition
where hydrogenated lecithin is present as a lamellar structure.
Accordingly, the obviousness rejection over a combination of
Popp, Goldberg, and Arata is erroneous and should be reversed.
(Br. 9).
We are not persuaded because, as discussed above, we agree with the
Examiner that Popp and Goldberg '210 render claim 1 obvious. The
Examiner presumably cites Arata to more directly address claim 4 (see Final
Act. 4--5), 20 which requires the triglyceride to be caprylic acid because Arata
teaches caprylic acid may be used in emulsions (see Arata ,r 132). Appellant
does not identify any error in the Examiner's specific use of Arata in
combination with Popp and Goldberg '210 and we therefore affirm this
rejection for the reasons already given above.
C 35 USC§ 103(a) over Chang, Yasuhiro, Simonnet, Goldberg '210,
Guo, and Edgar
20 We note that Popp teaches a "preferred, nonlimiting triglyceride useful in
the present compositions is caprylic/capric triglyceride" (Popp ,r 162), so we
are unclear why the Examiner felt the need to further add Arata.
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The Examiner finds Chang teaches "foaming compositions containing
an emulsion. The compositions further contain lecithin, a thickening agent
and propylene glycol and glycerin" (Final Act. 5). The Examiner
acknowledges Change does not teach "the use of hydrogenated lecithin and
the inclusion of a propellant" (id.).
The Examiner finds Simonnet teaches that "hydrogenated lecithin
stabilizes the emulsions" and Y asuhiro teaches the "preparation of foam
emulsions containing water, capryl-caprin glycerides, oil and a sunscreen"
(Final Act. 6). The Examiner finds that Guo and Edger teach that
"liposomes are prone to lipid oxidation/peroxidation" and Edger teaches to
"use lecithins with nonoxidizable saturated fatty acid ester groups which
cannot be oxidized" (id.). The Examiner relies on Goldberg '210 for the
teaching of propellant (see Final Act. 7). The Examiner finds it obvious to
replace Chang's lecithin with hydrogenated lecithin because "the
unsaturated fatty acid chain in lecithin are susceptible to lipid
oxidation/peroxidation damage and [to] decrease this damage one can use
hydrogenated lecithin" (Final Act. 6-7).
Appellant contends "the Examiner is in error for stating that lamellar
membrane structures are the same as liposomes. Accordingly, the
Examiner's rejection over Chang and/or JP 2003/0132038 in combination
with Simonnet and Goldberg, optionally in further combination with Guo
and/or Edgar is erroneous and should be reversed" (Br. 11 ).
We agree with the Examiner. As already discussed above, we agree
that the scope of the term "lamellar membrane phase" is reasonably
interpreted in light of the Specification and prior art as encompassing
liposomes. Moreover, the Examiner also relies upon Simonnet, which
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teaches formulation of an "organogel" for cosmetics (Simonnet 1 :8-13).
Simonnet explains that the term "organogel" refers to "gelled systems
comprising two immiscible phases (water in oil) stabilized in lecithin
enriched with phosphatidylcholine ... and usually hydrogenated" (Simonnet
2: 17-20). Simonnet teaches that these "organogel" "emulsions have a
lamellar phase and are in the form of gels even in the absence of gelling
agents, hence the name organogels which denotes this type of emulsion
irrespective of the orientation of the emulsion (W /0 or 0/W)" (Simonnet
2:23-27).
Thus Simonnet alone reasonably suggests a composition comprise
water and a lamellar membrane phase while Goldberg '210, as discussed
above, teaches formulating cosmetics as "self-foaming lamellar
compositions" and teaches "aerosol barrier dispensing systems to dispense
the self-foaming lamellar compositions" (FF 6, 9, Simonnet 2: 17-27). We
agree with the Examiner that the cited prior art reasonably suggests
modifying Simonnet's composition, which comprises a water phase and a
lamellar phase that includes hydrogenated lecithin, to include a propellant to
form a foam because the "generation of a foam provides a product which has
various desirable consumer attributes, including ease of handling and
spreading, and desirable sensory properties" (FF 12).
We also agree with the Examiner's reliance on Guo and Edgar to
provide reasons to replace lecithin with hydrogenated lecithin because "the
saturated chains substantially eliminate lipid oxidative/peroxidative lipid
damage on storage at room temperature" (Guo 4:4--6) and "[l]ipid oxidation
can be reduced through ... using lecithins with non-oxidizable saturated
fatty acid ester groups which cannot be oxidized" (Edgar 4: 1---6).
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D. 35 US.C. § 103(a) over Friedman, Simonnet, and Goldberg '210
The Examiner finds "Friedman discloses moisturizing foamable
compositions ( oil in water emulsions) containing caprylic and capric
triglycerides, propylene glycol, glycerol, thickening agents, substances with
HLB between 9 and 14 and a container containing propellant" (Final Act. 8).
The Examiner acknowledges that "Friedman does not specifically teach
hydrogenated lecithin" but states Friedman does teach inclusion of an
"amphoteric surfactant" (id.).
The Examiner finds the inclusion of hydrogenated lecithin would have
been obvious because "Simonnet teaches that emulsions enriched with
lecithin have lamellar phases" and "hydrogenated lecithin stabilizes the
emulsions" (Final Act. 8). The Examiner also finds it obvious "to heat the
components and homogenize in a homogenizer since Simonnet teaches such
a procedure to form an emulsion containing hydrogenated lecithin for
cosmetic use" (id. at 9).
Appellant asserts several errors for this rejection, including teaching
away by Simonnet, the absence of a reasonable expectation of success, and
because not all amphoteric surfactants form lamellar membranes (Br. 12-
14). We find these arguments unpersuasive for the reasons given below.
Appellant contends
Simonnet discloses in Example 1 a process in which the
mixture of the two phases is homogenized at a temperature
higher than the phase transition temperature of the surfactant
(hydrogenated lecithin). In contrast, the presently claimed
invention carries out the homogenization at a temperature lower
than the phase transition temperature of hydrogenated lecithin.
Therefore, Simonnet in fact teaches away from the presently
claimed invention. The Examiner should be reversed for this
reason.
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(Br. 12).
We find this argument unpersuasive because Appellant does not
identify any teaching in Simonnet that criticizes, discredits, or discourages
formation of a foam comprising a water phase, a lamellar membrane phase,
and a propellant as required by claim 1. A teaching away requires a
reference to actually criticize, discredit, or otherwise discourage the claimed
solution. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) ("The prior
art's mere disclosure of more than one alternative does not constitute a
teaching away from any of these alternatives because such disclosure does
not criticize, discredit, or otherwise discourage the solution claimed").
We do, however, agree with Appellant that Simonnet clearly prefers
performing the homogenization "at a temperature about 5° C. above the
phase transition temperature of the said surfactant" (Simonnet 9:2-3) rather
than "below the phase transition temperature of the hydrogenated lecithin"
as recited in claim 1. But the process of manufacture is only relevant "if the
process by which a product is made imparts 'structural and functional
differences' distinguishing the claimed product from the prior art"
Greenliant Systems, Inc. v. Xicor LLC, 692 F.3d 1261, 1268 (Fed. Cir.
2012). Appellant provides no persuasive evidence that performing the
homogenization process of Simonnet to form the obvious foam composition
of Friedman, Simonnet, and Goldberg '210 results in a product that differs
from that of claim 1. "[ A ]ttorney argument [is] not the kind of factual
evidence that is required to rebut a prima facie case of obviousness." In re
Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997).
Appellant contends "there is no reasonable expectation of success in
arriving at the claimed invention since, in Simonnet, the mixture is
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homogenized at a temperature higher than the phase transition temperature
of hydrogenated lecithin" (Br. 12). Appellant specifically contends that
"[ c ]ontrary to the contention of the Examiner, Applicant, in fact, did not
recognize that amphoteric surfactants form lamellar membranes under every
situation. Applicant discovered that hydrogenated lecithin forms lamellar
membrane only when the emulsion is homogenized below the phase
transition temperature and under high energy mixing conditions." (Id. at
13). Appellant contends
Applicant has clearly distinguished the claimed hydrogenated
lecithin, which is a phospholipid, from such conventional water
soluble emulsifiers which form micelle association instead of
lamellar structures. There is absolutely no recognition by
Applicant that amphoteric surfactants in general and under any
and all conditions form lamellar membranes as the Office
Action contends.
(id. at 14).
We find this argument unpersuasive for several reasons. First, the
Specification teaches that when homogenization is performed "[ a ]bove the
phase transition temperature, they spontaneously form in water exclusively
large multilamellar vesicles (LUV)" (Spec. 5). Thus, even the Specification
recognizes that using temperatures preferred by Simonnet will result in a
"lamellar membrane phase" as required by claim 1. As discussed above,
claim 1 does not exclude multilamellar vesicles from satisfying the "lamellar
membrane phase" requirement.
Second, we also agree that there is a reasonable expectation of success
because Goldberg '210 teaches self-foaming lamellar compositions (FF 6-7)
and even provides working examples that form "lamellar compositions EE
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and GG" (Goldberg '210 ,r 150) with mixing (see Goldberg '210, table 7)
that is not recited as being performed at elevated temperatures.
Third, while Simonnet clearly prefers a temperature about 5° C above
the phase transition temperature of the lecithin (Simonnet 9:2-3), Simonnet
provides no evidence or examples that the use of lower temperatures will not
function. In Example 1, Simonnet teaches homogenization at 60° C., "a
temperature about 5° C. above the phase transition temperature of the
surfactant in the glycerol phase, which for hydrogenated lecithin is between
50° C. and 55° C." (Simonnet 9:37--42). However, in Example 3, Simonnet
homogenizes at 55°C., a temperature within the range disclosed for phase
transition for hydrogenated lecithin, whereby a "fine organogel is obtained"
(Simonnet 10:40--46).
We note that Appellant does not provide any persuasive evidence that
the ordinary artisan would have expected elimination of a "lamellar
membrane phase" if homogenization was performed as suggested by the
combination of Friedman, Goldberg '210, and Simonnet.
E. 35 USC§ 103(a) over Goldberg '968, Chang, and Simonnet
The Examiner finds Goldberg '968 teaches "lamellar post foaming
cleansing composition and dispensing system containing oil in water
emulsions . . . . The compositions contain a propellant and post foaming
agents" (Final Act. 10). The Examiner finds Chang teaches "foaming
compositions containing an emulsion. The compositions further contain
lecithin, a thickening agent and propylene glycol and glycerin" (id.). The
Examiner acknowledges that Goldberg '968 and Chang do not teach the use
of hydrogenated lecithin but finds Simonnet "teaches that hydrogenated
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lecithin stabilizes emulsions" (id.). The Examiner finds the combination
obvious because "hydrogenated lecithin stabilizes the emulsion as taught by
Simonnet" (id. at 11 ).
Appellant contends Goldberg '968 "requires the use of one or more
anionic surfactants in its foam-forming composition while other types of
surfactants are only optional" (Br. 16). Based on this, Appellant contends
"there is no motivation for those of ordinary skill in the art to combine
[Goldberg '968,] which requires an anionic surfactant, with Chang and
Simonnet" (id.).
We find this argument unpersuasive because Goldberg '968 teaches
emulsions including "self-foaming lamellar compositions, and to aerosol
barrier dispensing systems to dispense the self-foaming lamellar
compositions" (Goldberg '968 1: 11-13). Thus, one reason the ordinary
artisan would include hydrogenated lecithin is because Simonnet teaches
that hydrogenated lecithin stabilizes emulsions (see Simonnet 2: 16-20
"gelled systems comprising two immiscible phases (water in oil) stabilized
in lecithin ... usually hydrogenated").
While Goldberg '968 prefers an anionic surfactant (see Goldberg '968
4:7), Goldberg '968 recognizes that phospholipids such as lecithin may be
included in the formulation (see Goldberg '968 25:25) and teaches that the
formulation may comprise "anionic, nonionic, amphoteric, and cationic
surfactants" (Goldberg '968 13:11-12). Thus, we are not persuaded by
Appellant's argument that Goldberg '968 is limited to anionic surfactants
and we agree with the Examiner that Simonnet provides a specific reason to
include a phospholipid such as hydrogenated lecithin for the purpose of
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stabilization of the emulsion, providing a reason to combine the teachings of
Simonnet and Goldberg '968.
Appellant also contends that in Goldberg '968, "the microstructures of
the disclosed surfactant consists of alternating surfactant layers and water
layers that fold to form submicron spherical onion like structures called
vesicles and liposomes and these bilayers are not flat and they are not
lamellar membrane structures as presently claimed" (Br. 16).
We find this argument unpersuasive because, as discussed above, the
"lamellar membrane phase" of claim 1 does not exclude liposomes and the
broadest reasonable interpretation of "lamellar membrane phase"
encompasses liposomes. "[L ]imitations are not to be read into the claims
from the specification." In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir.
1993).
F. 35 US.C. § 103(a) over Chang, Popp, Lanzendoifer, and Goldberg
'210
The Examiner relies on Chang, Popp, and Goldberg '210 as already
discussed (see Final Act. 11) and notes that Popp teaches "foam emulsion
formulations containing ceramide 3" (id.). The Examiner cites Lanzendorfer
to teach "the use of ceramide 3 in cosmetic and dermatological foam
preparations" (id. at 12). The Examiner finds the use of ceramide 3 in the
foam composition obvious because "both Popp and Lanzendorfer teach the
use of ceramide 3 in dermatological compositions" (id.).
Appellant contends that the "presently claimed lamellar structures are
distinctly different from the liposomes of Popp. Lanzendorfer fails to cure
the deficiencies of the combination of Chang, Popp, and Goldberg" (Br. 17).
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We find this argument unpersuasive for the reasons given above. As
already noted, the "lamellar membrane phase" of claim 1 does not exclude
liposomes and the broadest reasonable interpretation of "lamellar membrane
phase" encompasses liposomes.
Appellant also contends
the present invention, in embodiments, has found that a stable
foam can be obtained based on an emulsion comprising a
lamellar phase without the use of conventional emulsifiers.
Additionally, the lamellar structures are also surprisingly
maintained in the foam, which is stable enough to be applied to
the skin. None of the prior art references, combined or in
isolation, suggests the claimed invention or its advantages.
(Br. 17).
We find the argument unpersuasive because Appellant provides no
evidence in support thereof. See In re Soni, 54 F.3d 746, 750 (Fed. Cir.
1995) ("It is well settled that unexpected results must be established by
factual evidence. Mere argument or conclusory statements ... [do] not
suffice.") In addition, Appellant does not compare their compositions with
the closest prior art nor provide any of the other data necessary to establish
an unexpected result. See In re Baxter Travenol Labs., 952 F.2d 388, 392
(Fed. Cir. 1991) ("[W]hen unexpected results are used as evidence of
nonobviousness, the results must be shown to be unexpected compared with
the closest prior art.").
SUMMARY
In summary, we affirm the obviousness rejections.
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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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