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 .
Non-Final Rejection
. The Status of Claims:
Claims 1-12, and 15-20 are pending.
Claims 1-12 and 15-19 are rejected.
Claim 20 is withdrawn from consideration.
DETAILED ACTION
1. Claims 1-12 and 15-19 are under consideration in this Office Action.
Priority
2. It is noted that this application is a 371 of PCT/EP2022/054044 02/18/2022, which has a foreign priority document, FRANCE FR2101621 02/19/2021.
Drawings
3. The drawings field on 8/4/23 are accepted by the examiner.
IDS
4. the IDS filed on 8/4/23 were reviewed by the examiner.
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 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.
Election/Restriction
Applicant’s election without traverse of Group I (claims 1-12, 15-19) on 2/18/26is acknowledged. Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected groups II, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12, and 15-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, the phrase “a hydrophilic film-forming agent chosen from a polyvinylpyrrolidone/vinyl acetate copolymer, polyvinylpyrrolidone in a non-crosslinked, crosslinked or acetate form, taken alone or in combination” is recited. This expression is improper because the Markush expression would require a close ended “and “ instead of an open ended “or” at the end. Appropriate correction is required.
In claim 7, the phrase “ a free radical scavenger” are recited. This expression can be vague because the claim does not define what the phrase “ a free radical scavenger” can be meant for the claim.
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
5. Claims 1-4 and 6-19 are rejected under 35 U.S.C. 103 as being unpatentable over Adres et al (US 2011/0224216 A1) in view of Making cosmeitcs (CreamMaker® WAX, Specification Sheet, 10/26/2018, page 1) and Bouvier et al (WO 2015/013709 A2) and Chappuis et al (CA 2810267).
Determination of the scope and content of the prior art
Adres et al discloses a topical composition containing brimonidine and its pharmaceutically acceptable salts ; preferably, the active ingredient of the composition is brimonidine tartrate (see page 2 ,a paragraph#0016).
Furthermore, it describes a cream formulation containing brimonidine tartrate in the following:
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as in claims 9-12 (see page 4 ,an example 4)
In general, an alpha adrenergic receptor agonist or pharmaceutically acceptable salt thereof is present in a formulation of the invention in an an1ount of from about 0.05 percent to about 5 percent of the total weight of the formulation (see page 3, a paragraph#0023).
The instant invention, however, differs from the prior art in that polyethylene glycol in combination with propylene glycol, polyvinylpyrrolidone/vinyl acetate copolymer, the combination of polyoxyethylene-20 sorbitan monostearate and cetostearyl alcohol and glycerine, and cetyl alcohol and stearyl alcohol and DL-tocopherol, xanthan gum , and antioxidant are unspecified in the prior art.
Making cosmeitcs teaches a non-ionic emulsifying wax containing a combination of the two emulsifiers polysorbate 60 and cetearyl alcohol. All kinds of cosmetics requiring emulsification as lotions, creams, gels. Its benefits are in the followings:
Non-ionic oil-in-water emulsifier (enables water & oil to mix)
Does not require the aid of other emulsifiers
Has high electrolyte tolerance
Has also dispersing, thickening and solubilizing properties (stabilizes essential oils) (see page 1 ,the first and second paragraphs).
‘
Furthermore, Bouvier et al discloses a topical composition containing an adrenergic receptor agonist, such as brimonidine for treating a skin disorder in the followings:
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As in claims 15-16 (see pages 19-20, table 6)
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(see page 22, table 10)
Furthermore, Chappuis et al teaches a composition containing brimonidine which may be in any of the galenical forms normally used for topical application, in particular in the form of solutions, lotions, gels, emulsions of liquid or semi-liquid consistency of the milk type, obtained by dispersion of a fatty phase in an aqueous phase (O/W) or vice versa (W/O), or suspensions or emulsions of soft, semi-liquid or solid consistency, of the cream or ointment type, or else microemulsions, microcapsules, microparticles or vesicular dispersions of ionic and/or nonionic type.(see page 7 , lines 7-14); in addition, the composition may contain antioxidants, preservatives, for example DL-alpha-tocopherol as in claim 18 (in part) and etc . (see page 6, lines 28-29) and he composition comprises at least one gelling agent. Such as a polysaccharides such as xanthan gums as in claim 6 (see page 7 ,line 29). The gelling agents may be used singly or in combination of two or more. They are preferably incorporated in amounts from 0.1 to 30% by weight, particularly, from 0.1 to 10% and more preferably from 0.2 to 5% by weight as in claim 19 (hereinafter may referred to simply as %) based on the total weight of the composition (see page 8, lines 4-7).
For the oily phase of the composition may comprise also a wax, fatty acids, or fatty alcohols or a mixture ranging in total from 2 to 15% by weight relative to the total weight of the composition. Among these compounds, Cetyl alcohol sold under the name Speziol® C18 by Cognis, stearyl alcohol as in claims 3-4 sold under the name Speziol® C16 by Cognis (see page 9 , lines 23-29)
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(see page 14, example 6)
Ascertainment of the difference between the prior art and the claims
The difference between the instant application and the applied Adres et al art is that the Adres et al does not expressly teach polyethylene glycol in combination with propylene glycol, polyvinylpyrrolidone/vinyl acetate copolymer, the combination of polyoxyethylene-20 sorbitan monostearate and cetostearyl alcohol and glycerine, and cetyl alcohol and stearyl alcohol and xanthan gum , antioxidant, and DL-tocopherol. The deficiencies of the Adres et al are cured by the Making cosmeitcs, Bouvier et al and Chappuis et al.
The difference between the instant application and the applied Making cosmeitcs art is that the Making cosmeitcs does not expressly teach the brimonidine and its salt polyethylene glycol in combination with propylene glycol, polyvinylpyrrolidone/vinyl acetate copolymer, and cetostearyl alcohol and glycerine, and cetyl alcohol and stearyl alcohol and DL-tocopherol and xanthan gum , antioxidant and oleyl alcohol . The deficiencies of the Making cosmeitcs are cured by Adres et al, Bouvier et al and Chappuis et al.
The difference between the instant application and the applied Bouvier et al art is that the Bouvier et al does not expressly teach polyethylene glycol, the combination of polyoxyethylene-20 sorbitan monostearate and cetostearyl alcohol, and cetostearyl alcohol, and cetyl alcohol and stearyl alcohol and DL-tocopherol and xanthan gum , oleyl alcohol and antioxidant. The deficiencies of the Bouvier et al are cured by Adres et al, the Making cosmeitcs and Chappuis et al.
The difference between the instant application and the applied Chappuis et al art is that the Chappuis et al does not expressly teach polyvinylpyrrolidone/vinyl acetate copolymer, polyoxyethylene-20 sorbitan monostearate and oleyl alcohol. The deficiencies of the Chappuis et al is cured by Adres et al, the Making cosmetics, and Bouvier et al
Resolving the level of ordinary skill in the pertinent art.
Regarding the Claims 7 and 19, with respect to the lack of disclosing e xanthan gum at a concentration of between 0.1 % and 1.5% or 0.2 and 1 % by weight of the total weight of the composition, the Chappuis et al does teach indirectly that one of the gelling agents such as xanthan gum may be used in amounts from 0.1 to 30% by weight, particularly, from 0.1 to 10% and more preferably from 0.2 to 5% by weight. Both claims are within the boundary range of the Chappuis et al. Thus, it would have been obvious to the skilled artisan in the art to be motivated to adjust the concentration of xanthan gum depending on its intended usage in the formulation of the composition in the absence of an unexpected result .
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Adres et al expressly discloses a topical composition containing brimonidine or brimonidine tartrate, methylparaben, BHA, cetostearyl alcohol, oleyl alcohol and other ingredients.
Although Adres et al does teach some other ingredients, for examples , polyethylene glycol in combination with propylene glycol, polyvinylpyrrolidone/vinyl acetate copolymer, polyoxyethylene-20 sorbitan monostearate and glycerine, and cetyl alcohol and stearyl alcohol and DL-tocopherol, xanthan gum , and antioxidant for the composition, Making cosmeitcs does teach the non-ionic emulsifying wax containing a combination of the two emulsifiers polysorbate 60 and cetearyl alcohol for various cosmetics requiring emulsification as lotions, creams, gels. Also, Bouvier et al does teach the topical composition containing brimonidine tartrate , propylene glycol, glycerin, methylparaben, PVP/VA copolymer and other ingredients for treating the skin disorder. Furthermore, the Chappuis et al does describe the topical composition containing brimonidine, polyethylene glycol in combination with propylene glycol, cetostearyl alcohol and glycerine, and cetyl alcohol and stearyl alcohol and DL-tocopherol, xanthan gum , and antioxidant in the forof solutions, lotions, gels, emulsions of liquid or semi-liquid.
All of the Adres et al and Bouvier et al and Chappuis et al are closely related to one and another with respect to the topical composition containing brimonidine tartrate or brimonidine, whereas, Making cosmeitcs does teach the non-ionic emulsifying wax containing a combination of the two emulsifiers polysorbate 60 and cetearyl alcohol for various cosmetics requiring emulsification as lotions, creams, gels.
,So, if the skilled artisan in the art had desired to improve the function of emulsification for the topical composition, it would have been obvious to the skilled artisan in the art before the effective filing date of the claimed invention to be motivated to incorporate Chappuis’s polyethylene glycol in combination with propylene glycol, and glycerine, and cetyl alcohol and stearyl alcohol and DL-tocopherol, xanthan gum , and antioxidant and Bouvier’s et al PVP/VA copolymer and Making cosmeitcs’s combined polysorbate 60 and cetearyl alcohol into Adres et al composition.
This is because the skilled artisan in the art would expect such combined compositions to be successful and feasible as guidance shown in the prior art.
Conclusion
Claims 1-12 and 15-19 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 5/13/2026
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