--DETAILED ACTION--
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s response dated June 23, 2026 is acknowledged.
Priority
This application is a 371 of PCT/EP2020/059300 filed on 04/01/2020 and claims foreign
priority in French application FR1903677 filed on 04/05/2019.
Claim Status
Claims 1-17, 19, 20, and 21 are pending. Claim 21 was newly added and reads on the elected invention. Claim 11 remains withdrawn. Claims 1 and 12 were amended. Claim 18 was canceled. Claims 1-10, 12-17, 19, 20, and 21 are examined.
Withdrawn Claim Rejections - 35 USC § 112
Rejection of claim 12 is withdrawn because rejection was obviated with claim amendments.
Withdrawn Double Patenting and Claim Rejections Under 35 USC § 103
All double patenting and obviousness rejections are withdrawn because the rejections were overcome with claim amendments. Braun and Tamarkin do not teach the newly added limitations in claim 1.
New Claim Rejections - 35 USC § 103
Necessitated by Amendment
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness
rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.
Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35
U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the
claims the examiner presumes that the subject matter of the various claims was commonly
owned as of the effective filing date of the claimed invention(s) absent any evidence to the
contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and
effective filing dates of each claim that was not commonly owned as of the effective filing date
of the later invention in order for the examiner to consider the applicability of 35 U.S.C.
102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
In the event the determination of the status of the application as subject to AIA 35 U.S.C.
102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the
statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a
new ground of rejection if the prior art relied upon, and the rationale supporting the rejection,
would be the same under either status.
Claims 1-4, 9, 10, 12, 14, 15, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Braun et al. (US 2012/0172457 Al Published July 5, 2012), Tamarkin et al. (US 2008/0069779 Al Published March 20, 2008), and Loupenok (WO 2010/096868 A1 Published September 2, 2010) as evidenced by Khayat (US 5,665,687 Date of Patent September 9, 1997).
The claims encompass a pharmaceutical composition suitable for topical use which is in
the form of a water-in-oil emulsion comprising, per I 00% of the composition's weight:
from 0.3 to 5% by weight of econazole,
from 60 to 90% by weight of a gelled aqueous phase (Al),
from 9.7 to 35% by weight of a fatty phase (A2) comprising at least one oil and an emulsifying
system comprising a combination of at least one emulsifying surfactant (S1) and of at least one
emulsifying surfactant (S2); wherein
the emulsifying surfactant (S1) is present in a concentration of greater than 1% and less than or equal to 3% by weight, and at least one oil comprises cocoyl caprylate/caprate in an amount greater than or equal to 8% and less than or equal to 15% by weight.
The teachings of Braun are related to crosslinking anionic polyelectrolytes of at least one
monomer having partially or totally salified strong acid function with at least one neutral
monomer and at least one monomer having formula I; and uses thereof as a thickener in topical
compositions (Abstract). The crosslinked anionic polyelectrolyte resulting from the
polymerization of partially salified or completely salified 2-methyl 2-[(1-oxo 2-propenyl) amino]
1-propanesulfonic acid, with at least one neutral monomer selected from acrylamide, (hydroxyethyl) acrylate or N,N-dimethyl acrylamide, and at least one monomer of formula (I)
(paragraph 0009). The anionic polyelectrolyte comprises between 5 mol. % and 95 mol. % of
monomers with a strong acid function, more particularly between 10 mol. % and 90 mol. % and
quite particularly between 20 mol. % and 80 mol. % (paragraph 0013). The anionic
polyelectrolyte in which the monomer with strong acid function is 2-methyl 2-[(1-oxo 2-
propenyl) amino] 1-propanesulfonic acid partially or completely salified in the form of
ammonium salt (paragraph 0015). Braun further teaches the use of the anionic polyelectrolyte as
thickener and/or as stabilizer and/or as emulsifier, of a cosmetic, dermopharmaceutical or
pharmaceutical topical composition (paragraph 0046). Braun teaches a topical composition
intended to be applied on the skin or the mucosae of humans or animals, comprising a topical
emulsion comprising at least one aqueous phase and at least one oily phase. This topical
emulsion can be a water-in-oil (w/o) emulsion. The oil phase can comprise one or more oils
(paragraph 0047). A topical composition can be intended for preparing a medicinal product
comprising an active principle (paragraph 0048). A topical composition comprises between 0.1
% and 10 wt.% and more particularly from 1 to 5 wt.% of the anionic polyelectrolyte as defined
above. The pH of the topical composition is preferably greater than or equal to 3 (paragraph
0050). It is compatible with MONTANOV 68, among others (paragraph 0054). Compositions
include a vitamin cream (paragraphs 0557-0565).
Braun does not teach econazole.
The teachings of Tamarkin are related to compositions comprising vitamins and/or
flavonoids using non-aqueous and aqueous carriers (paragraph 0007). The compositions
comprise a therapeutic agent (paragraph 0086). The compositions comprise a surface active
agent selected from PEG-30 dipolyhydroxystearate and MONTAVON 68 (cetearyl alcohol and
cetearyl glucoside), and mixtures thereof (paragraph 0162). Surface-active agents include any
agent linking oil and water in the composition, in the form of emulsion. A surfactant's
hydrophilic/lipophilic balance (HLB) describes the emulsifier's affinity toward water or oil, HLB
is defined for non-ionic surfactants. The HLB scale ranges from 1 (totally lipophilic) to 20
(totally hydrophilic), with 10 representing an equal balance of both characteristics. Lipophilic
emulsifiers form water-in-oil (w/o) emulsions; hydrophilic surfactants form oil-in-water (o/w)
emulsions. The HLB of a blend of two emulsifiers equals the weight fraction of emulsifier A
times its HLB value plus the weight fraction of emulsifier B times its HLB value (weighted
average). In many cases a single surfactant may suffice. In other cases, a combination of two or
more surfactants is desired (paragraph 0243). Paragraph 0252 teaches a table with various
surfactants and their corresponding HLB values, where PEG-30 dipolyhydroxystearate has an
HLB value of 5.5. Suitable vitamins include vitamin E (paragraph 0407). Compositions include
additional therapeutic agents including an anti-infective agents (paragraph 0195), such as an
antifungal agent (paragraph 0196), wherein the antifungal agent is selected from econazole
(paragraph 0197).
The teachings of Braun and Tamarkin are related to topical compositions comprising a
vitamin and a therapeutic agent, and it would have been obvious to have combined their
teachings because they are in the same field of endeavor.
Regarding claim 1, it would have been prima facie obvious to a person of ordinary skill
in the art before the effective filing date of the claimed invention to have formed a water-in-oil
(w/o) emulsion for topical use comprising a crosslinked anionic polyelectrolyte, water, an oil, at
least one emulsifying surfactant, and a therapeutic agent, with a reasonable expectation of
success because Braun teaches a topical composition in the form of a w/o emulsion, comprising a
crosslinked anionic polyelectrolyte, water, an oil, at least one emulsifying surfactant, and a
therapeutic agent. It would have been obvious to have formed the composition as a vitamin
cream because Braun teaches an example of a vitamin cream comprising vitamin E.
Braun does not teach specific therapeutic agents, and it would have been obvious to have
looked to the teachings of Tamarkin for therapeutic agents that are known to be used in vitamin
creams because Tamarkin is concerned with topical compositions comprising vitamins,
specifically vitamin E, and teaches that compositions further comprise a therapeutic agents such
as an antifungal econazole. Therefore, it would have been obvious to have formed Braun's
vitamin w/o emulsion comprising econazole, with a reasonable expectation of success because
Tamarkin teaches that econazole is a suitable therapeutic agent for use in topical vitamin
compositions. It would have been obvious to have added econazole to the composition in a
concentration of 1 wt. %, with a reasonable expectation of success because Tamarkin teaches 1
% as an exemplary concentration of ciclopirox in a topical composition known for treating a
fungal infection (Table 1 paragraph 0650 and Table 2 in paragraph 0748) and 1 % as an
exemplary concentration of clotrimazole and terbinafine HCl in a topical composition (Table 2
paragraph 0748). Tamarkin also teaches adding a therapeutically effective amount of an active
agent (paragraph 0388), therefore it would have been obvious to the skilled artisan to determine
therapeutically effective amounts of econazole through routine experimentation and arrive at the
claimed concentration range. The claimed concentration range is obvious because it encompasses
1 %, and there is no evidence that the claimed concentration range is critical.
Braun describes the crosslinked polyelectrolyte as swellable in water and makes a
transparent gel (paragraphs 0007 and 0010), therefore it would have been reasonable to expect
the water phase of the w/o emulsion to comprise the crosslinked anionic polyelectrolyte thereby
forming a gelled aqueous phase. It would have been obvious to have formed the emulsion using
the crosslinked anionic polyelectrolyte in a concentration of 0.1-10 wt. % because Braun teaches
0.1-10 wt.% as a suitable concentration range of the polyelectrolyte in the composition. It would
have been obvious to have used water in a concentration sufficient to make the emulsion.
Example 7 is described as an emulsion, prepared by emulsifying B (water) in A (mixture of oils
and emulsifier) and addition of a polyelectrolyte, wherein water is present in a concentration of
66.2 wt.%, the mixture of oils and emulsifier 25.6 wt.%, and polyelectrolyte 3 wt.%
(paragraphs 0104-0121). Example 8 teaches an emulsion comprising 26 wt.% of A (emulsifier
and oils), 71 wt.% water, and 2.5 wt.% polyelectrolyte (paragraphs 0122-0131). It would have
been obvious to have formed the w/o emulsion using exemplified concentration ranges of the oil
phase and the aqueous phase, and selecting an emulsifier that is suitable for making a w/o
emulsion. A person of ordinary skill in the art would have known that a w/o emulsifier would
have been required in order to form a w/o emulsion. It would have been obvious to have formed
the emulsion using 66.2-71 wt. % water and 25.6-26 wt. of an oil phase comprising oils and an
emulsifying system. The aqueous phase would have comprised water and the polyelectrolyte and
its concentration would have been 69.2-73.5 wt.%. The claimed concentration range of the
gelled phase is obvious because it encompasses the prior art concentration range of the gelled
aqueous phase. The concentration range of the fatty phase is obvious it encompasses 25.6-26 wt.
% which is the concentration range of the combination of emulsifier and oils that make up the oil
phase. While Braun teaches compositions in the form of a w/o emulsion, Braun does not teach
emulsifiers suitable for making a w/o emulsion. A person skilled in the art would have been
motivated to look to the teachings of Tamarkin for guidance on selecting an emulsifying system
that is suitable for making a w/o emulsion because Tamarkin teaches examples of emulsifiers,
their corresponding HLB values, and how to select an emulsifier or a combination of emulsifiers
to make an w/o or o/w emulsion. It would have been prima facie obvious to have formed Braun's
w/o emulsion using a single lipophilic emulsifier or a combination of emulsifiers having a
weighted HLB value that favors formation of a w/o emulsion, with a reasonable expectation of
success because it was known from Tamarkin that a w/o emulsion may be formed using a single
lipophilic emulsifier or a combination of emulsifiers having a weighted HLB value suitable for
making a w/o emulsion. A person skilled in the art would have recognized that the weighted
HLB value would have been in the lipophilic range of HLB values. One of skill in the art would
have been motivated to use a mixture of emulsifiers because Tamarkin teaches that the stability
of a composition can be improved when a combination of at least one non-ionic surfactant
having HLB of less than 9 and at least one non-ionic emulsifier having a HLB of equal to or
more than 9 is employed and the ratio between the two is 4:1 to 1:4, where the resultant HLB of
such a blend of at least two emulsifiers is between about 5 and 18 (paragraphs 0266-0267). It
would have been obvious to have selected PEG-30 dipolyhydroxystearate and Montanov 68 as
the combination of an emulsifier having a HLB less than 9 and an emulsifier having an HLB
equal to or greater than 9, and varied their ratios from 4:1 to 1:4, to make an emulsifier system
having an HLB value in a lipophilic range and suitable for making a w/o emulsion. HLB of
Montanov 68 is 10 as evidenced by Khayat (column 2 lines 45-52). HLB of PEG-30
dipolyhydroxystearate is 5.5 as evidenced by Tamarkin paragraph 0252). Montanov 68 is a
mixture of cetearyl alcohol and a cetearyl glucoside, which encompasses n-hexadecanol,
n-octadecanol, n-hexadecanol glucoside, and n-octadecanol glucoside.
It would have been obvious to have used Lanol 1688, shea butter, paraffin oil, and Lanol
14M as the at least one oil in the fatty phase, with a reasonable expectation of success because
Braun teaches these oils as suitable for use in the oil phase of an emulsion (examples 7 and 8).
The claimed fatty phase is obvious because Braun's fatty phase is present in a
concentration of about 26 wt. % and comprises Montanov 68 (mixture of n-hexadecanol,
n-octadecanol, n-hexadecanol glucoside, and n-octadecanol glucoside), PEG-30
dipolyhydroxystearate, and an oil comprising one or more of Lanol 1688, shea butter, paraffin
oil, and Lanol 14M.
The limitations that require said pharmaceutical composition El to remain homogenous at
a temperature greater than or equal to 20°C and less than or equal to 25°C and after storage at
45°C for a minimum of three months describes a property of the claimed composition when
placed under certain conditions. The prior art composition meets all of the structural
requirements of the claimed composition and it would have been reasonable to expect the prior
art composition to have the same properties as claimed composition when placed under identical
conditions, absent evidence to the contrary. A composition and its properties are inseparable.
Regarding the newly added limitation that requires the emulsifying surfactant S1 to be present in an amount of greater than 1% and less than or equal to 3% by weight, it would have been obvious to have formed composition to comprise Montanov 68 (mixture of n-hexadecanol, n-octadecanol, n-hexadecanol glucoside, and n-octadecanol glucoside) in a concentration from 2 wt. % to 5 wt. % because Braun teaches a cream comprising Montanov 68 in a concentration of 2 wt. % (example 5, paragraphs 0084-0094), a milk composition comprising Montanov 68 in a concentration of 3 wt. % (example 10 paragraphs 0145-0153), and a cream comprising Montanov 68 in a concentration of 5 wt. % (example 16 paragraphs 0220-0228). The claimed concentration range is obvious because it overlaps with 2-5 wt. %.
Braun and Tamarkin do not teach the newly added limitation that requires the at least one oil to comprise cocoyl caprylate/caprate in an amount greater than or equal to 8% and less than or equal to 15% by weight in claim 1 and limitations of claim 21. However, it would have been prima facie obvious to the skilled artisan to have modified Braun’s composition by replacing Lanol 1688 with coco caprylate/caprate, with a reasonable expectation of success because it was known from Loupenok that coco-caprylate/caprate and cetearyl ethylhexanoate (Lanol 1688) are suitable oil-miscible organic solvents (page 12 lines 13-20) intended for making emulsions comprising a therapeutic agent such as econazole (page 10 lines 13-19). Replacing one equivalent with another to obtain a predictable result supports obviousness. Furthermore, Braun teaches using Lanol 2681 which is a mixture of copra carprylate and caprate (paragraph 0709) and teaches using it in a composition in a concentration of 3 wt. % (paragraphs 0345-0350). As evidenced by instant application, Lanol 2681 is cocoyl caprylate/caprate.
It would have been obvious to have used the oil miscible organic solvent in a concentration from 3% to 15% by weight because Loupenok teaches 3-15 wt. % as a suitable concentration range for oil miscible organic solvents (page 12 lines 8-12). The claimed concentration range in claim 1 is obvious because it overlaps with 3-15 wt. %. The concentration of 8 wt. % in claim 21 is obvious because it is encompassed by 3-15 wt. %.
Regarding claim 2, the aqueous phase comprises a crosslinked anionic polyelectrolyte
and water. In one embodiment Braun teaches a composition comprising 66.2 wt. % water and 3
wt. % polyelectrolyte. Based on the total weight of the aqueous phase, water is present in a
concentration of about 95 wt. % and the polyelectrolyte is present in a concentration of about 5
wt.%. Claimed concentration ranges are obvious because they encompass Braun's
corresponding concentrations.
Regarding claim 3, it would have been obvious to have used a crosslinked anionic
polyelectrolyte comprising 20 mol. and 80 mol. % of 2-methyl 2-[(1-oxo 2-propenyl) amino] 1-
propanesulfonic acid partially or completely salified in the form of ammonium salt, with a
reasonable expectation of success because Braun teaches that the crosslinked anionic electrolyte
comprises between 5 mol. % and 95 mol. % of monomers with a strong acid function, more
particularly between 10 mol. % and 90 mol. % and quite particularly between 20 mol. % and 80
mol. % (paragraph 0013), wherein the anionic polyelectrolyte in which the monomer with strong
acid function is 2-methyl 2-[(1-oxo 2-propenyl) amino] 1-propanesulfonic acid partially or
completely salified in the form of ammonium salt (paragraph 0015).
Regarding claims 4, 14, and 15, Braun modified with Tamarkin teaches econazole.
Regarding claim 9, it would have been obvious to have varied weight ratio of SI and $2
from 4: 1 to 1 :4 because Tamarkin teaches varying the two emulsifiers in said range of ratios.
Claimed range of weight ratios is obvious because it overlaps with prior art range.
Regarding claim 10, Braun's modified composition contains all the elements as claimed
and it would have been reasonable to expect the composition to be suitable for use in therapy in a
human being or animal.
Regarding claim 12, it would have been obvious to have formed Braun's composition to
further comprise perfumes, preservatives, or pigments, with a reasonable expectation of success
because Braun teaches that the topical composition further comprises compounds conventionally
used in compositions of this type, including perfumes, preservatives, and pigments (paragraph
0051).
Combining prior art elements according to known methods to obtain predictable results
supports obviousness and the selection of a known material suitable for its intended purpose
supports obviousness.
Claims 6, 7, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over
Braun, Tamarkin, and Loupenok as evidenced by Khayat as applied to claims 1-4, 9, 10, 12, 14, 15, and 21 above, and further in view ofMerat (US 2016/0015609 Al Published January 21, 2016).
The claims further define the at least one emulsifying surfactant S1.
The teachings of Braun and Tamarkin are relied upon as summarized above. They do not
teach the limitations of claims 6, 7, 19, and 20.
The teachings of Merat are related to o/w emulsions comprising 60-98 wt.% of aqueous
phase including a crosslinked anionic polyelectrolyte, and 2-40 wt. % of fatty phase comprising
an emulsifying system S with at least one surfactant selected from alkylpolyglycoside
compositions, alkylpolyglycoside and fatty alcohol compositions, polyglycerol esters,
alkoxylated polyglycerol esters, polyglycolpolyhydroxystearates, polyglycerol
polyhydroxystearates, alkoxylated polyglycerol polyhydroxystearates, polyethylene glycol/alkyl
glycol copolymers (Abstract). The term "alkyl polyglycoside compositions" denotes a
composition (Cl) represented by formula (II):
Rl-O-(G)x-H (II), in which x represents a decimal number between 1.05 and 5, G represents a
reducing sugar residue and R.sub.1 represents a saturated or unsaturated, linear or branched
hydrocarbon-based aliphatic radical, optionally substituted with one or more hydroxyl groups
comprising from 12 to 36 carbon atoms, said composition (CI) consisting of a mixture of
compounds represented by formulae (11), (12), (13), (14) and (15): Rl-O-(G)l-H (11), RlO-(G)2-
H (12), Rl-O-(G)3-H = (13), Rl-O-(G)4-H (14), and Rl-O-(G)5-H (15) in the respective molar
proportions al, a2, a3, a4 and a5 such that: the sum al+a2+a3+a4+a5 is equal to I and that the
sum I +2a2+3a3+4a4+5a5 is equal to x (paragraphs 0050-0052). In formula II, the group Rl-0 is
linked to G via the anomeric carbon of the saccharide residue so as to form an acetal function
(paragraph 0061). According to a particular aspect in the definition of formula II as defined
above, RI represents a radical chosen from at least one of the elements of the group consisting of
n-dodecyl, n-tetradecyl, n-hexadecyl, n-octadecyl, n-eicosyl, n-docosyl, 2-hexyldecyl, 2-
octyldecyl, 2-hexyldodecyl, 2-octyldodecyl and 2-decyltetradecyl radicals, and G represents a
reducing sugar selected form glucose among others (paragraph 0064). Polyglycol
polyhydroxystearate is depicted in formula VI (paragraph 0082). Paragraph 0157 teaches
examples of compositions that comprise PEG-30 dipolyhydroxystearate.
The teachings of Merat and Braun modified with Tamarkin are related to topical w/o
emulsions and it would have been obvious to have combined them because they are in the same
field of endeavor.
Regarding claims 6, 19, and 20, it would have been prima facie obvious to a person of
ordinary skill in the art before the effective filing date of the claimed invention to have further
modified Braun as modified by Tamarkin by replacing the emulsifying system comprising the
combination of Montanov 68 and PEG-30 dipolyhydroxystearate with an emulsifying system
comprising a combination of alkyl polyglycoside and polyglycol polyhydroxystearate as taught
by Merat, with a reasonable expectation of success because Merat teaches a combination of alkyl
polyglycoside and polyglycol polyhydroxystearate as suitable for making a w/o emulsion. It
would have been obvious to have selected composition Cl comprising compounds of formula II
as the alkyl polyglycoside with a reasonable expectation of success because Merat teaches said
composition Cl as an example of alkyl polyglycoside suitable for making a w/o emulsion. It
would have been obvious to have selected PEG-30 dipolyhydroxystearate as the polyglycerol
polyhydroxystearate of formula VI with a reasonable expectation of success because Merat
teaches PEG-30 dipolyhydroxystearate as an example of compound of formula VI. One of skill
in the art would have had a reasonable expectation of success in modifying Braun in view of
Merat because Merat teaches this surfactant system as suitable for making a w/o emulsion.
Regarding claim 7, it would have been prima facie obvious to a person of ordinary skill
in the art before the effective filing date of the claimed invention to have further modified the
emulsion of Braun as modified by Tamarkin by replacing the emulsifier system with an
emulsifier system comprising a mixture of alkylpolyglycoside, fatty alcohol, and polyglycol
polyhydroxystearate, with a reasonable expectation of success Merat teaches an w/o emulsion
comprising an emulsifying system comprising at least one emulsifier selected from
alkylpolyglycoside, fatty alcohol, and polyglycol polyhydroxystearate. It would have been
obvious to have selected composition C2 comprising 10-50 wt. % of the composition C 1
represented by formula II as the alkyl polyglycoside, and 50-90 wt. % of at least one fatty
alcohol of formula III including n-dodecanol, with a reasonable expectation of success because
Merat teaches said composition C2 as an example of alkyl polyglycoside and fatty alcohol as
suitable for making a w/o emulsion (paragraphs 0068-0073). It would have been obvious to have
selected PEG-30 dipolyhydroxystearate as the polyglycerol polyhydroxystearate of formula VI
with a reasonable expectation of success because Merat teaches PEG-30 dipolyhydroxystearate
as an example of compound of formula VI. One of skill in the art would have had a reasonable
expectation of success in modifying Braun in view of Merat because Merat teaches this
surfactant system as suitable for making a w/o emulsion. The claimed concentration ranges of at
least one alkyl polyglycoside and at least one fatty alcohol are obvious because they overlap with
their corresponding concentration ranges in the claims.
Combining prior art elements according to known methods to obtain predictable results
supports obviousness and the selection of a known material suitable for its intended purpose
supports obviousness.
Claims 5, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Braun, Tamarkin, and Loupenok as evidenced by Khayat as applied to claims 1-4, 9, 10, 12, 14, 15, and 21 above, and further in view of Espinoza (US 2003/0049281 Published March 13, 2003).
The claims further define econazole by counterion salt.
Braun, Loupenok, and Tamarkin do not teach salts of econazole.
The teachings of Espinoza are related to a topical delivery composition which employs a
multivesicular emulsion in combination with a pharmaceutically/pharmacologically active agent
(Abstract). Example 1 teaches a multi vesicular emulsion comprising 1 % by weight of
econazole nitrate, a known anti-fungal drug (paragraphs 0037-0037).
The teachings of Espinoza and Braun modified with Tamarkin and Loupenok are related to emulsions comprising an econazole salt and wherein the emulsions are intended for topical application, and it would have been obvious to have combined their teachings because they are in the same field of endeavor.
It would have been prima facie obvious to a person of ordinary skill in the art before the
effective filing date of the claimed invention to have formed Braun's composition using
econazole salt because Braun teaches forming the compositions with a salt of an antifungal drug.
However, Braun does not teach suitable salts of econazole. It would have been obvious to have
modified Braun's composition in view of Tamarkin by selecting econazole nitrate as the salt of
econazole, with a reasonable expectation of success because it was known from Espinoza that
econazole nitrate is suitable for topical delivery via an emulsion composition. The selection of a
known material based on its suitability for its intended use supports obviousness.
Claims 8 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Braun, Tamarkin, and Loupenok as evidenced by Khayat as applied to claims 1-4, 9-10, 12, 14, and 15 above, and further in view ofBusetti (WO 2016/071827 Al, Published May 12, 2016).
The claims encompass the composition of claim 1, wherein the at least one emulsifying
surfactant S2 consists of at least one polyglycol polyhydroxystearate of formula XII.
The teachings of Busetti are related to a water in oil emulsion composition intended for
skin application (Abstract and page 6 lines 1-4). The compositions comprise an emulsifying
agent selected from PEG-30 dipolyhydroxystearate (Simaline WO) among others (paragraph
bridging pages 6-7).
Regarding claims 8 and 13, it would have been obvious to have selected the commercial
product Simaline WO as the source of PEG-30 dipolyhydroxystearate, with a reasonable
expectation of success because Simaline WO was known in the art the commercial source of
PEG-30 dipolyhydroxystearate and it was known to be used in compositions intended for skin
application. The selection of a known material based on its suitability for its intended purpose
supports obviousness. As evidenced by page 34 of the specification, Simaline WO is a suitable
source of PEG-30 dipolyhydroxystearate in applicant's invention and absent evidence to the
contrary, Simaline WO is encompassed by the instantly claimed compound XII.
New Double Patenting Rejections
Necessitated by Amendment
The nonstatutory double patenting rejection is based on a judicially created doctrine
grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or
improper timewise extension of the "right to exclude" granted by a patent and to prevent possible
harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where
the conflicting claims are not identical, but at least one examined application claim is not
patentably distinct from the reference claim(s) because the examined application claim is either
anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg,
140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d
2010 (Fed. Cir. 1993); In re Langi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van
Ornum, 686 F.2d 937,214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
(CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR l.32l(c) or l.32l(d) may
be used to overcome an actual or provisional rejection based on nonstatutory double patenting
provided the reference application or patent either is shown to be commonly owned with the
examined application, or claims an invention made as a result of activities undertaken within the
scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination
under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §
2146 et seq. for applications not subject to examination under the first inventor to file provisions
of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR l.32l(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory
double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be
accompanied by a reply requesting reconsideration of the prior Office action. Even where the
NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection LB. I.
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c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-10, 12-17, 19, 20, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-7, 10-19, 21, and 22 of copending Application No. 17/276,693 (reference application) and further in view of Tamarkin, Braun, and Loupenok.
Copending claims encompass a water in oil emulsion that contains all of the elements as
claimed emulsion except for the active agent econazole. The teachings of Tamarkin are relied
upon as summarized above. Copending claims require an anti-inflammatory, whereas present
claims require econazole. It would have been prima facie obvious to a person of ordinary skill in
the art before the effective filing date of the claimed invention to have modified the emulsion in
copending claims by replacing the anti-inflammatory substance with econazole, with a
reasonable expectation of success because it was known from Tamarkin that econazole may be
formulated for topical application in the form of w/o emulsion. The claimed properties of the
composition are obvious because the composition of copending claims modified by Tamarkin
meets all of the structural requirements of the instantly claimed invention and it would have been
reasonable to expect the composition of the copending claims modified by Tamarkin to have the
same properties as claimed composition when placed under identical conditions because a
composition and its properties are inseparable. Combining prior art elements according to known
methods to obtain predictable results supports obviousness.
This is a provisional nonstatutory double patenting rejection because the patentably
indistinct claims have not in fact been patented.
Regarding the newly added limitations in claim 1 and claim 21, it would have been prima facie obvious to have formed the copending composition by selecting Montanov 68 as the emulsifying agent S1 and in a range of concentrations of 2-5 wt. %, with a reasonable expectation of success because Braun teaches that Montanov 68, which is a mixture of n-hexadecanol, n-octadecanol, n-hexadecanol glucoside, and n-octadecanol glucoside (as evidenced by paragraph 0162 of Tamarkin), is a suitable emulsifier for making topical therapeutic compositions and teaches concentrations 2 wt. %, 3, wt. %, and 5 wt. % as suitable for making topical compositions. Copending claims require S1 emulsifier comprising a composition of alkyl polygolycosides and fatty alcohols, and Montanov 68 meets this requirement. The claimed concentration range is obvious because it overlaps with 2-5 wt. %.
Copending claims do not teach suitable contents of the at least one oil. It would have been obvious to have selected coco-caprylate/caprate as the at least one oil to form the fatty phase and it would have been obvious to have added it in a concentration of 3-15 wt. %, with a reasonable expectation of success because Loupenok teaches that coco-caprylate/caprate is a suitable oil miscible organic solvent that facilitates the solubilization of the active agent in the oil phase and teaches using it in a concentration of 3-15 wt. %. The claimed concentration range in claim 1 and concentration in claim 21 are obvious because they overlap with 3-15% wt.
Response to Arguments
Applicant's arguments provided in the remarks dated June 23, 2026, were fully
considered but are not persuasive for the following reasons.
Applicant argued that the claimed invention is commensurate in scope with inventive composition F3 and that the inventive composition has unexpected properties compared to the comparative composition F’2.
Argument is not persuasive because it is not clear why the applicant considers the results observed for comparative composition F’2 and inventive composition F3 surprising. The compositions have different active agents and different amount of Sepineo SE 68 and different amounts of PEG-400. There are three differences between the two compositions and it cannot be determined which variable affects the asserted unexpected properties.
The claimed composition is broader than composition F3 and the applicant did not show that the asserted unexpected properties observed for composition F3 would have occurred over the entire breadth of the claimed compositions. See MPEP 716.02 for requirements applicant has to meet in order to overcome obviousness rejections with unexpected results.
Argument against double patenting rejection over 17/276,693 is not persuasive because
the rejection was modified to address the newly added limitations.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALMA PIPIC/Primary Examiner, Art Unit 1617
Prosecution Insights