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 .
Election/Restrictions
Applicant’s election of Group I (claims 1-24 and 26-37) in the reply filed on September 19, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 39, 41-44, 71-75 and 121-125 have been withdrawn from considered.
Claims 1-24 and 26-37 are examined on the merits.
Claim Rejections - 35 USC § 103
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.
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.
Claims 1-5, 7, 9-11, 13-15, 18, 20, 21, 23, 26, 27, 29, 36 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. (KR 1918250 B1, published November 13, 2018) (“Yu” hereunder) in view of Popescu et al. (US 4708861 A, published November 24, 1987) (“Popescu” hereunder) and Johnson et al. (US 20180116926 A1, published on May 3, 2018) (“Johnson” hereunder).
Claim 1 is directed to a liposomal topical formulation, comprising:
a plurality of liposomes;
an aqueous gel matrix in which the plurality of liposomes are dispersed, wherein the aqueous gel matrix comprises a gelling agent, a water-soluble silicone compound, a film forming agent, and water; and
dutasteride entrapped within the liposomes.
YU teaches nanoliposome microbubble conjugate comprising a drug for hair loss treatment, such as finasteride, dutasteride or minoxidil, etc. See US equivalent, US 11337923 B2, abstract. The reference teaches that dutasteride inhibits 5-alpha reductase type 1 and type 2 and prevents the conversion of testosterone into dihydrotestosterone, thereby slowing the progression of hair loss. See col. 1, line 54 – col. 2, line 10. The reference teaches In Experimental Example 4, epilated back of mice was treated with nanoliposome-microbubble conjugate comprising finasteride; the application was made five times at an interval one day and resulted in hair growth.
POPESCU teaches a topical gel comprising liposomes containing entrapped bioactive agent; the liposomes are sequestered in a gel matrix and provided in a sustained release of the bioactive agent. The reference further teaches that the gel matrix inhibits the dispersion and clearance of the sequestered liposomes without interfering with the ability of the liposomes to release the entrapped bioactive agent. The reference further teaches that the release rate can be manipulated by altering the composition of the liposomes and/or gels. See abstract. Although the reference does not specifically mention the term a “film forming agent”, the reference does teach using polyacrylamide, which applicant defines as such. See col. 9, lines 3-17. The reference specifically teaches, “If the molecular weight of the liposome-entrapped bioactive agent is known, one skilled in the art could prepare a gel to obtain the approximate diffusion rate desired by controlling the acrylamide concentration and crosslinking of the gel.” Example 6.1 discloses an agarose gel comprising a plurality of liposomes comprising amphiphilic lipids and agarose as the gelling material; agarose is provided in an aqueous solution; thus, it is obvious that the composition comprises an aqueous gel matrix. Popescu teaches that topical application may be particularly useful the systemic release of drugs such as hormones to control growth, fertility, sugar metabolism, etc., and in treatments which require repeated applications. See col. 10, lines 4 - 25.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify the teachings of Yu and incorporate dutasteride in liposomes in the gel matrix formulation of Popescu; the skilled artisan would have been motivated to do so, as the latter teaches that such delivery system is useful as a sustained, systemic release carrier of active pharmaceutical ingredients (APIs) with reduced number of applications. Since both references teach topical application of APIs entrapped in liposomes, the skilled artisan would have been had a reasonable expectation of success in combining the teachings of the references and making a liposome gel with sustained release of dutasteride.
Popescu fails to teach a water-soluble silicone compound.
JOHNSON teaches that using a combination of water-soluble silicones and water dispersible silicones can improve the deposition of certain cosmetic ingredients and/or form a protective layer over the ingredients while still remaining permeable to atmospheric oxygen. See [0014]. The reference teaches a sunless tanning composition with such combination, which is said to have reduced tacky or sticky feeling after application of the composition. See abstract. PEG-8 and PEG/PPG-10/Dimethicone are among the suggested water- soluble silicones; polymethylsilsesquioxane is among the water insoluble silicone compounds that can be used in combination with the water-soluble silicone compound. See [0026-0028].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify the teachings of Yu and Popescu, and incorporate to the gel matrix composition a combination of a water-soluble compound such as PEG-8 or PEG/PPG-10/Dimethicone and a water insoluble silicone polymer such as polymethylsilsesquioxane as motivated by Johnson, as the latter teaches and suggests such pair would improve the deposition of cosmetic ingredients and protect the applied composition without tacky feel. Since both references teach aqueous-based topical formulations, the skilled artisan would have had a reasonable expectation of successfully combining the teachings of the reference and producing a stable gel composition with improved deposition and protection of the active ingredients with acceptable sensory feel. See present claims 1-4 and 9-11.
Regarding claims 2, 20, 21, 23, 26 and 27, Johnson teaches that the total concentration of silicone-containing polymers may between about 0.05 -5 %w/w, while the concentration of a single silicone polymer may be between about 0.005-3 %w/w. See [0031]. Thus, it would have been obvious to one of ordinary skill in the art that the water dispersible silicone polymer such as polymethylsilsesquioxane would have been used within such range.
Regarding claims 5, Popescu teaches that natural or synthetic lecithin is used in making liposomes. See col. 4, line 22 – col. 5, line 31.
Regarding claim 7, Popescu teaches that any gelling materials can be used, including polyacrylate. See (61-63); the present claims 1 and 7.
Regarding claims 13 and 14, Popescu further teaches that liposomes can be also prepared in a monophasic solvent system, wherein the solvents can be 2-propanol (propanediol).
Regarding claim 15, although Yu/Popescu fails to specifically teach a humectant, Johnson teaches that using humectants in a topical formulation is well known.
Regarding claim 18, Popescu teaches examples showing liposome sequestered in 0.5-2% agarose gel. See, e.g., example 6.3. Using such gel concentration to make a topical formulation comprising dutasteride entrapped in liposome would have been prima facie obvious.
Regarding claim 29, it is well settled in patent law that combining art-recognized functional equivalent is prima facie obvious. MPEP 2144.06 I. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). In this case, Yu establishes that dutasteride and minoxidil, an anti-hypertensive vasodilator, are both effective as a drug for hair loss treatment by preventing the conversion of testosterone into dihydrotestosterone. See col. 4, lines 7 – 15. Thus, combining the two art-recognized functional equivalents to make a third composition to be used for the same purpose of treating hair loss would is prima facie obvious.
Regarding claims 36 and 37, as there is no particular teaching or suggestion to make a pulse-release formulation in the references, providing a sustained release of dutasteride entrapped in liposomes would have resulted in the presently claimed composition comprising at least 75 % or 90 % of the total dutasteride in the formulation.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Yu, Popescu and Johnson as applied to claims 1-5, 7, 9-11, 13-15, 18, 20, 21, 23, 26, 27, 29, 36 and 37 above, and further in view of Jung (KR 101193952 A, published October 24, 2012).
Although Popescu teaches using lecithin is making liposomes, the reference fails to specifically disclose hydrogenated lecithin.
Jung teaches an aqueous cosmetic composition for prevention of hair loss and improvement of hair growth, the composition comprising 5-alpha reductase suppressors entrapped in liposomes. The reference teaches hydrogenated lecithin is used as a surfactant to prepare liposomes. See translation, p. 16, Example 1.
Substituting equivalents known for the same purpose is prima facie obvious. See MPEP 2144,06, II. As Popescu and Jung establish that natural and synthetic lecithin and hydrogenated lecithin are all amphipathic compounds useful in entrapping active pharmaceutical ingredients in liposomes, substituting one for the other to make liposomes would have been prima facie obvious.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Yu, Popescu and Johnson as applied to claims 1-5, 7, 9-11, 13-15, 18, 20, 21, 23, 26, 27, 29, 36 and 37 above, and further in view of Zhang et al. (US 20200060961 A1, priority to August 23, 2018) (“Zhang” hereunder).
Although Popescu teaches that polyacrylates can be used as a gelling material, the reference fails to specifically disclose a C10-C30 alkyl acrylate crosspolymer.
Zhang teaches that C10-C30 alkyl acrylate crosspolymers are useful as polymeric emulsifiers for providing viscosity and sensory benefits. See [0065-0069].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify the teachings of Popescu and use a C10-C30 alkyl acrylate crosspolymer in making the gel formulation as motivated by Zhang, since the latter teaches that the crosspolymer provides sensory benefits. As Popescu teaches and suggests using polyacrylates as a gelling agent, the skilled artisan would have had a reasonable expectation of successfully combining the teachings of the references and producing a stable gel matrix with improved sensory feel.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Yu, Popescu and Johnson as applied to claims 1-5, 7, 9-11, 13-15, 18, 20, 21, 23, 26, 27, 29, 36 and 37 above, and further in view of Needleman (US 8790710 B1, published on July 29, 2014) and Naughton (US 20060134074 A1, published on June 1, 2006).
Yu/Popescu/Johnson fail to disclose dimethyl isosorbide.
Needleman teaches that dimethyl isosorbide is a penetration enhancer used in skin care products. See col. 2, lines 20-23.
Naughton teaches compositions and methods for promoting hair growth, the compositions comprising hair growth promoting compounds which induces skin vascularization, such as minoxidil, which is a vasodilator. The reference teaches topically administering vascularization inducers with skin penetration enhancers. See [0132]. The reference further teaches that conventional methods for treating alopecia includes an immunosuppressive steroid also See [0139].
It would have been obvious to one of ordinary skill in the art before the time of the effective filing date of the present application to modify the teachings of Yu/Popescu/Johnson and incorporate to the composition a skin penetration enhancer such as dimethyl isosorbide as motivated by Needleman and Naughton. The skilled artisan would have been motivated to do so, as 1) Needleman teaches that dimethyl isosorbide is a skin penetration enhancer and 2) Naughton teaches and suggests that agents for treating hair loss and enhancing hair regrowth are administered with skin penetration enhancers. As all references are directed to topical delivery of active pharmaceutical ingredients, the skilled artisan would have had a reasonable expectation of successfully combining the teachings of the references and producing a stable topical formulation which enhances the transportation of dutasteride across the skin layers.
Claims 16 is rejected under 35 U.S.C. 103 as being unpatentable over Yu, Popescu and Johnson as applied to claims 1-5, 7, 9-11, 13-15, 18, 20, 21, 23, 26, 27, 29, 36 and 37 above, and further in view of Chan (TW 201731486 A, published on September 16, 2017).
Regarding claim 16, although Popescu fails to teach the specific humectant of the present claims, the Johnson example formulation contains caprylyl glycol. More specifically, Chan teaches that caprylyl glycol and ethylhexylglycerin are well known skin emollients or humectants and suggests that these are particularly suitable for topical formulations for scalp application for hair loss treatment.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify the teachings of Yu/Popescu/Johnson and incorporate to the composition caprylyl glycol and/or ethylhexylglycerin as suggested by Chan, as the latter specifically disclose such as skin emollients and humectants suitable for scalp application. Since the Chan formulation is also used in hair loss treatment, and Johnson discloses an example which contain an aqueous product comprising water-soluble silicone and water-dispersible silicone polymers with caprylyl glycol, the skilled artisan would have had a reasonable expectation of successfully producing a stable formulation with improved scalp conditioning properties.
Claims 17 and 30-35 are rejected under 35 U.S.C. 103 as being unpatentable over Yu, Popescu, and Johnson as applied to claims 1-5, 7, 9-11, 13-15, 18, 20, 21, 23, 26, 27, 29, 36 and 37 above, and further in view of Jindal (US 20200147071 A1, priority to November 8, 2018).
Yu fails to disclose the specific concentration amount of dutasteride of the present claims.
Jindal teaches therapeutically effective amount of dutasteride in topical formulation for promoting hair growth in human patients is about 0.001% to about 1% w/w. See [0027].
Regarding claim 30 and 33, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify the teachings of Yu/Popescu/Johnson and added dutasteride in the amount of about 0.001-1 % of the composition as motivated by Jindal, as the latter discloses a therapeutically effective amount of dutasteride in a topical formulation for promoting hair growth in human subjects. Since the aim of the Yu reference is the same, the skilled artisan would have had a reasonable expectation of successfully producing a liposome composition comprising a therapeutically effective amount of dutasteride for promoting hair growth in human patients suffering from hair loss.
Regarding claim 17, the amount of the plurality of liposomes per se does not represent the effective amount of the entrapped active ingredient. In view of Jindal’s suggested therapeutic amount of dutasteride, i.e., about 0.001- 1.0 wt%, one of ordinary skill in the art would have been obviously motivated to use the amount of liposomes needed to supply such suggested amount of dutasteride.
Regarding claim 31, 32, 34 and 35, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this case, since Jindal generally teaches the therapeutically effective amount of dutasteride in topical formulations for treating hair loss, adjusting the concentration of the active ingredient depending on the targeted potency and finding the optimal concentration by routine experimentations would have been well within the skill in the art.
Claim 19, 22, 24 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Yu, Popescu and Johnson as applied to claims 1-5, 7, 9-11, 18, 20, 21, 23, 26, 27, 29, 36 and 37 above, and further in view of Wang et al. (US 2008/0118537 A1, May 22, 2008) (“Wang” hereunder).
As discussed above, Johnson teaches that the concentration of a single silicone polymer may be between about 0.005-3 w/w; the reference fails to teach the polysilsesquioxane concentration of the present claims 19 and 24.
Wang teaches that particulate materials such as polymethylsilsesquioxane are used in cosmetic compositions to impart excellent skin sensory, feel, light diffusing effect, smooth texture, anti-caking and water repellency. See [0002]. The reference teaches using up to 65wt % of the silicone resin in a formulation; example 7 particularly teaches an aqueous liquid foundation comprising 15 % of the PMSQ powder.
Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See In re Aller. In this case, both Johnson and Wang teach and suggest that the amount of the polysilsesquioxane in a topical formulation is adjusted to provide acceptable sensory feel, without tacky feel while still enabling oxygen to permeate through the applied composition. Since Wang discloses a topical formulation comprising 15 % of the PMSQ powder, discovery of the optimal PMSQ concentration by routine experimentations would have been well within the ordinary skill in the art.
Double Patenting
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 Longi, 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 1.321(c) or 1.321(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 1.321(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 I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11, 17-24 and 26-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. US 11786466 B2.
The present claim 1 is directed to a liposomal topical formulation, comprising:
a plurality of liposomes; an aqueous gel matrix in which the plurality of liposomes is dispersed, wherein the aqueous gel matrix comprises a gelling agent, a water-soluble silicone compound, a film forming agent, and water; and dutasteride entrapped within the liposomes.
The reference claim 1 is directed to a liposomal topical formulation, comprising:
a plurality of liposomes; an aqueous gel matrix in which the plurality of liposomes is dispersed, wherein the aqueous gel matrix comprises a gelling agent, a water-soluble silicone compound that is a PEG-X silicone or a PPG-X-silicone wherein X is an integer of 6-20, a polysilsesquioxane compound at a concentration of 1-20% by weight of the total composition, and water; and one or more active pharmaceutical ingredients (API) entrapped in the liposomes. The API is defined to include dutasteride. See col. ___.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a liposomal topical formulation having overlapping limitations.
Regarding the present claims 2-4, the reference teaches the polysilsesquioxane concentration in the present claim 1; the reference claim 5 teaches poly(methylsilsesquioxane).
Regarding the present claims 5 and 6, the reference claims 9 and 25 teach lecithin and hydrogenated lecithin, respectively.
Regarding claims 7 and 8, the reference claim 25 teaches that the gelling agent comprises C10-C30 alkyl acrylate cross polymer.
Regarding claims 9 -11, the reference claims 1-3 teach the water-soluble silicone compound PEG-X silicone wherein X is an integer of 6-20 and PEG-8 dimethicone.
Regarding claims 17-19 and 30-35, the concentrations of AIP-containing liposomes, the gelling agent and the water-soluble silicone are disclosed in the reference claims 13-15, respectively.
Regarding claims 20-24 and 26-28, the concentration of the polysilsesquioxane compound is disclosed in the reference claim 1 and further defined to include 1-10%, 5-10% or 5 %. See col. 9, bridging paragraph.
Regarding claim 29, the reference claim 26 teaches that the API further includes an anti-hypertensive vasodilator.
Regarding claim 30 and 33 the reference claim 25 teaches that the one or more APIs comprise finasteride at a concentration of 2.5 % w/w of the total weight of the composition; using another 5-alpha reductase inhibitor, dutasteride, within the same amount would have been prima facie obvious.
Regarding claim 31, 32, 34 and 35, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller. In this case, since the reference claim generally teaches the concentration of another 5-alpha reductase, adjusting the concentration of dutasteride depending on the targeted potency and finding the optimal concentration by routine experimentations would have been well within the skill in the art.
Regarding claims 36 and 37, as there is no particular teaching or suggestion to make a pulse-release formulation in the references, providing a sustained release of dutasteride entrapped in liposomes would have resulted in the presently claimed composition comprising at least 75 % or 90 % of the total dutasteride in the formulation.
Claims 12-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. US 11786466 B2 as applied to claims 1-11, 17-24 and 26-37 above, and further in view of Needleman and Naughton.
Regarding claim 12, the reference claims fail to disclose dimethyl isosorbide.
Needleman teaches that dimethyl isosorbide is a penetration enhancer used in skin care products. See col. 2, lines 20-23.
Naughton teaches compositions and methods for promoting hair growth, the compositions comprising hair growth promoting compounds which induces skin vascularization, such as minoxidil, which is a vasodilator. The reference teaches topically administering vascularization inducers with skin penetration enhancers. See [0132].
It would have been obvious to one of ordinary skill in the art before the time of the effective filing date of the present application to modify the teachings of the reference claims and incorporate to the composition a skin penetration enhancer such as dimethyl isosorbide as motivated by Needleman and Naughton. The skilled artisan would have been motivated to do so, as 1) Needleman teaches that dimethyl isosorbide is a skin penetration enhancer and 2) Naughton teaches and suggests that agents for treating hair loss and enhancing hair regrowth are administered with skin penetration enhancers. As all references are directed to topical delivery of active pharmaceutical ingredients, the skilled artisan would have had a reasonable expectation of successfully combining the teachings of the references and producing a stable topical formulation which enhances the transportation of dutasteride across the skin layers.
Regarding claims 13 and 14, Needleman further teaches that alcoholic components such as propanediol, phenoxyethanol and aminomethyl propanol are commonly used as a cosmetically acceptable vehicle, bactericide and neutralizing agent, respectively. See col. 11, lines 3-11; col. 9, lines 25 -38; col.10, lines 3-15. Thus, incorporating such to stabilize a topical formulation would have been prima facie obvious.
Claims 15 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. US 11786466 B2 as applied to claims 1-11, 17-24 and 26-37 above, and further in view of Chan.
Regarding claims 15 and 16, although the reference claims fail to teach humectants, Chan teaches that caprylyl glycol and ethylhexylglycerin are well known skin emollients or humectants and suggests that these are particularly suitable for topical formulations for scalp application for hair loss treatment.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify the teachings of the reference claims and incorporate to the composition caprylyl glycol and/or ethylhexylglycerin as suggested by Chan, as the latter specifically disclose such as skin emollients and humectants suitable for scalp application. Since the Chan formulation is also used in hair loss treatment, the skilled artisan would have had a reasonable expectation of successfully producing a stable formulation with improved scalp conditioning properties.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 10265283 B2, teaching a topical delivery system comprising a depot component to keep the active agent locally in the skin and to reduce distribution of the active agent to the blood stream.
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/GINA C JUSTICE/Primary Examiner, Art Unit 1617