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 .
Status of Application
The Amendments and Remarks filed on 05/18/26 are acknowledged.
Claim 7 was cancelled.
Claims 1-3, 8-9, and 12 were amended.
New claim 13 was added.
Claims 1-6 and 8-13 are pending and included in the prosecution.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 05/18/26 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statement.
Please see the attached copy of PTO-1449.
Response to Amendments/Arguments
Rejection of claims under 35 USC § 112(b)
In light of the amendment of claims 7 and 8, the rejection of these claims under 35 USC 112(b) as being indefinite, is withdrawn.
New claim 13
In light of the addition of new claim 13, a new objection to this claim is made.
Claim Objections
Claim 13 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Notice for all US Patent Applications filed on or after March 16, 2013
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.
Claim Rejections - 35 USC § 103
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 of this title, 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.
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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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.
Claims 1-6 and 8-12 are again rejected under 35 U.S.C. 103 as being unpatentable over Louis et al. (US 2014/0010884 A1 – “Louis”), as evidenced by Beneke et al. (Molecules 2009, 14, 2602-2620 – “Beneke”) in view of Lanquetin et al. (US 2008/0227763 A1 – “Lanquetin”).
Instant claim 1 is drawn to an aqueous gel composition for topical application comprising
a physiologically active ingredient,
an aqueous dispersion of ethylcellulose (EC), and
a carrageenan,
wherein the aqueous gel composition has a viscosity of 100 mPa.s to 6000 mPa.s at shear rate of 0.01 s-1 as determined using a rheometer.
Louis teaches dermatological compositions comprising retinoids, dispersed benzoyl peroxide and carrageenans, wherein the compositions are useful for treating dermatological conditions and afflictions linked to disorders of cell differentiation and/or proliferation and/or keratinization, notably for treating acne vulgaris (Title and Abstract). Aqueous gels are disclosed as suitable forms of the composition ([0110]). Additional gelling agents other than the carrageenans are disclosed ([0127]) and include EC ([0128]). Louis teaches that the carrageenans are capable of conferring a viscosity on the composition sufficient to keep the retinoid and the benzoyl peroxide in suspension, and include the iota form of carrageenan ([0104]) and Gelcarin GP379NF® ([0109]).
Beneke (used as an evidentiary reference only) teaches that iota-carrageenan or ι-carrageenan produces elastic gels (Page 2609, 1st ¶, line 3) and that commercially available ι-carrageenan is Gelcarin® GP-379 NF (Page 2609, 2nd ¶, lines 1-3).
Louis does not expressly teach an aqueous dispersion of EC.
Lanquetin teaches a topical hormonal composition with systemic action wherein the topical composition comprises an active principle, a film-forming agent, and a gelling agent (Title, Abstract, claims 18, and 20-21). Natural gelling agents include carrageenans ([0042]). The gelling agent also includes cellulose derivatives ([0043]), which further include EC (Aquacoat®) ([0045]). The film-forming agent also includes cellulose derivatives ([0060]) which further includes an aqueous dispersion of EC under the tradename Aquacoat ECD30® ([0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a dermatological composition comprising the active ingredients retinoids and benzoyl peroxide, and gelling agents including carrageenans and EC, as taught by Louis, in view of the topical hormonal composition which comprises an active principle and a gelling agent or film-forming agent which is an aqueous dispersion of EC, as taught by Lanquetin, and produce the instant invention.
One of ordinary skill in the art would have been motivated to use the aqueous dispersion of EC as taught by Lanquetin in place of the EC in the dermatological composition of Louis because the simple substitution of one known element for another to obtain predictable results is obvious. Please see MPEP 2141(III)(B). Furthermore, both references teach the inclusion of EC, and one of ordinary skill in the art would have found it advantageous to disperse the active ingredients of Louis in an aqueous dispersion of the gel ([0110]) by using the aqueous dispersion of EC as taught by Lanquetin ([0061]), and have a reasonable expectation of success in producing a functional dermatological or topical composition.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claim 1, the limitation of an aqueous gel composition for topical application would have been obvious over the dermatological compositions (Title and Abstract) in the form of aqueous gels ([0110]), as taught by Louis; and the topical composition in the form of a gel (Abstract and claims 18, and 20-21), as taught by Lanquetin.
Regarding instant claim 1, the limitation of (a) a physiologically active ingredient would have been obvious over the retinoids and benzoyl peroxide (Abstract and claim 1), as taught by Louis.
Regarding instant claim 1, the limitation of (b) an aqueous dispersion of EC would have been obvious over the EC ([0128]), as taught by Louis, in view of the aqueous dispersion of EC under the tradename Aquacoat ECD30® ([0045] and [0061]), as taught by Lanquetin.
Regarding instant claim 1, the limitation of (c) a carrageenan would have been obvious over the carrageenans ([0127]), the iota form of carrageenan ([0104]) and Gelcarin GP379NF® ([0109]), as taught by Louis, and the carrageenans ([0042]), as taught by Lanquetin.
Regarding instant claim 1, the limitation of the gel having a viscosity of 100 to 6000 mPa.s at shear rate of 0.01 s-1 would have been obvious over the viscosity of 185 cP (or mPa.s) at 100 s-1 ([0287]), the viscosity of 300 cP (or mPa.s) at 100 s-1 ([0293]), and the viscosity of 185 cP (or mPa.s) at 100 s-1 ([0299]), as taught by Louis.
Regarding instant claim 2, the limitation of the concentration of EC in the range of 5-50% by weight of the composition would have been obvious over the additional gelling agent ([0127]) which includes EC ([0128]) and the overlapping amount of the additional gelling agent which ranges from 0.01% to 20% by weight, with respect to the total weight of the composition (claims 1 and 4-6), as taught by Louis. According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Regarding instant claim 3, the limitation of the concentration of carrageenan in the range of 0.1-5% by weight of the composition would have been obvious over the overlapping amount of carrageenan which ranges from 0.1% to 20% by weight, with respect to the total weight of the composition (claims 1 and 3), as taught by Louis. Please see MPEP 2144.05.
Regarding instant claims 4 and 5, the limitations of the type of carrageenan would have been obvious over the iota form of carrageenan ([0104]) and Gelcarin GP379NF® ([0109]), as taught by Louis, as evidenced by Beneke (Page 2609, 1st and 2nd ¶s).
Regarding instant claim 6, the limitation of the physiologically active ingredient would have been obvious over the retinoids and benzoyl peroxide (anti-acne agent) used for treating acne vulgaris (Abstract and claim 1), as taught by Louis.
Regarding instant claim 8, the limitation of the gel having a yield stress of 10 to 200 Pa determined as storage modulus using a rheometer would have been obvious over the composition comprising the same components as taught by Louis and Lanquetin since the recited limitation is a property of the composition and is naturally present. Louis teaches the same composition, having the same components, in the same arrangement, and for the same topical or dermatological application. Louis also teaches that the “yield point” (T0, expressed in pascals) means the force necessary (minimum shear stress) to overcome the cohesive forces of Van der Waals type and to bring about flow ([0274]). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the composition, then the properties are also taught by the prior art. The burden is shifted to Applicant to show that the prior art product does not possess or render obvious the same properties as the instantly claimed product.
Regarding instant claim 9, the limitation of a pH in the range of 3-8 would have been obvious over the pH between 6 and 7 ([0075]), as taught by Lanquetin.
Regarding instant claim 10, the limitation of an auxiliary ingredient would have been obvious over the buffers, preservatives ([0170]), surfactants (claims 14-16), emollients ([0116]), and penetrating agents (claims 11-13), as taught by Louis; and the surfactants ([0034]), as taught by Lanquetin.
Regarding instant claim 11, the limitation of the composition providing controlled release of the physiologically active ingredient on topical application thereof would have been obvious over the dermatological compositions (Title and Abstract) in the form of aqueous gels ([0110]), as taught by Louis; and the topical composition in the form of a gel with systemic action (Abstract and claims 18, and 20-21), as taught by Lanquetin. The recited limitation of controlled release is a property of the composition and is naturally present. Louis and Lanquetin teach the same composition, having the same components, in the same arrangement, and for the same topical or dermatological application. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the composition, then the properties are also taught by the prior art. The burden is shifted to Applicant to show that the prior art product does not possess or render obvious the same properties as the instantly claimed product. Moreover, instant claim 11 is silent with respect to any time period or release parameters.
Regarding instant claim 12, the limitations of (i) – (iv) of the method of preparing the composition would have been obvious over the preparation of the dermatological compositions (Title and Abstract) in the form of aqueous gels ([0110]), wherein the composition contains retinoids and benzoyl peroxide (Abstract and claim 1), carrageenans ([0127]), the iota form of carrageenan ([0104]) and Gelcarin GP379NF® ([0109]), wherein the preparation includes preparing active phase 1, active phase 2, aqueous phase, mixing the active phases, preparation of the fatty phase, emulsification, addition of the single active phase ([0198]-[0222]), wherein the mixture is heated ([0208]) and then the preparation is cooled ([0210]), as taught by Louis, in view of the aqueous dispersion of EC under the tradename Aquacoat ECD30® ([0045] and [0061]), as taught by Lanquetin.
Response to Arguments
Applicant’s arguments (Pages 6-10, filed 05/18/26) with respect to the rejection of claims 1-12 under 35 USC § 103(a) as being unpatentable over Louis, as evidenced by Beneke, in view of Lanquetin have been fully considered but are not persuasive.
Applicant argues that none of the cited references provides any composition having a viscosity of 100 mPa·s to 6000 mPa·s at shear rate of 0.01 s-1 as determined using a rheometer as recited in currently amended claim 1 or the concentration of ethylcellulose recited in newly added claim 13.
This is not persuasive because one of ordinary skill in the art would have found it obvious to measure or determine the viscosity of the composition using different shear rates. Instant claims do not recite any features, components, concentrations, or arrangement of components that differ from those of the cited prior art references. The measurement of viscosity of the composition is a property of the composition. Since the prior art teaches the same composition, having the same components, the viscosity of the composition is also taught.
Applicant argues that Louis’s viscosities require measurement at shear rate of 100 s-1, which is 10,000x the shear rate of 0.01 s-1 recited in the currently amended claims, and that these are different values, not overlapping ranges. Applicant refers to Vilimi et al. ("Microfluidic Rheology: An Innovative Method for Viscosity Measurement of Gels and Various Pharmaceuticals," Gels, l 0(7):464 (2024) at Abstract) and argues that: “At least because non-Newtonian fluids (e.g., aqueous gel compositions) exhibit different viscosities at different shear rates, the rejection fails to establish that the viscosities allegedly provided by Louis overlap with the viscosities recited in the currently amended claims. The rejection also fails to demonstrate that viscosity measured at a shear rate of 100 s-1 (e.g., as allegedly done in Louis) can be extrapolated to a viscosity measured at a shear rate of 0.01 s-1 (e.g., the claimed subject matter). Lanquetin fails to remedy this deficiency, as the rejection failed to demonstrate that Lanquetin provides any shear rates for viscosity measurements …” Applicant argues that “close” ranges between a cited reference and a claim are insufficient to establish a prima facie case of obviousness.
The Vilimi reference was fully considered and Examiner acknowledges that the shear rate values are different. Reference to obviousness of ranges, overlap of ranges, and MPEP 2144.05 with respect to the viscosity and shear rate is removed. However, since the prior art reference Lanquetin teaches the same aqueous dispersion of EC, i.e., Aquacoat ECD30® ([0061]), one of ordinary skill in the art would have expected the same viscosity at the shear rate recited in the instant claims. Since the prior art teaches the same composition, having the same components, the viscosity of the composition is also taught.
Moreover, the concentration of the aqueous dispersion of EC and the concentration of carrageenan which contribute to the viscosity of the claimed aqueous gel composition are also taught by the prior art. As recited in instant claim 2, the concentration of EC in the range of 5-50% by weight of the composition would have been obvious over the additional gelling agent ([0127]) which includes EC ([0128]) and the overlapping amount of the additional gelling agent which ranges from 0.01% to 20% by weight, with respect to the total weight of the composition (claims 1 and 4-6), as taught by Louis. According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.” Regarding instant claim 3, the limitation of the concentration of carrageenan in the range of 0.1-5% by weight of the composition would have been obvious over the overlapping amount of carrageenan which ranges from 0.1% to 20% by weight, with respect to the total weight of the composition (claims 1 and 3), as taught by Louis. Please see MPEP 2144.05.
Since the prior art teaches the same components that contribute to the viscosity of the claimed aqueous gel composition in the same or overlapping concentrations of these components, the claimed property of viscosity at particular shear rates would also be expected from the prior art.
Therefore, the rejection of 12/18/25 is maintained for claims 1-6 and 8-12.
Please note that newly added claim 13 is objected to as being dependent upon a rejected base claim.
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Frohoff-Hülsmann et al. (International Journal of Pharmaceutics 177 (1999) 69-82 – “Frohoff-Hulsmann”) teach that Aquacoat® ECD-30 is an aqueous ethyl cellulose dispersion with a solid content of 29-32% (Page 71, section 2.1.2.1). However, Frohoff-Hulsmann teaches the use Aquacoat® ECD-30 as a film former for pellet coating and not in an aqueous gel composition, wherein the ethylcellulose is in a concentration ranging from 23.64% to 29.7% by weight of the aqueous gel composition, as recited in instant claim 13.
Conclusion
No claims are allowed.
Claim 13 is objected to.
THIS ACTION IS MADE FINAL. 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 extension fee 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARADHANA SASAN whose telephone number is (571)272-9022. The examiner can normally be reached Monday to Friday from 6:30 am to 3:00 pm.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615
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