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 .
Priority
The instant application filed 03/24/2023 is a National Stage entry of PCT/US21/51910, International Filing Date: 09/24/2021; PCT/US21/51910 claims priority from Provisional Application 63082613 , filed 09/24/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 4/12/2023, 4/13/2023, 6/13/2025 complies with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
In response to a restriction requirement filed 09/24/2025, Applicant elects, without traverse, Group I, namely, claims 1-19 and new claims 21-23, drawn to the combination of a biodegradable polymer and a hair regrowth agent. Applicant also elects the species of 1) the biodegradable polymer poly(lactide-co-glycolide) (claims 1-19 and new claims 21-23 read on the elected species); 2) the hair regrowth agent finasteride (claims 1-19 and new claims 21-23 read on the elected species); 3) the plasticizer dimethyl tartrate (claims 1-19 and new claims 21-23 read on the elected species); 4) the surfactant or emulsifier polyvinyl alcohol (claims 1-19) and new claims 21-23 read of the elected species; and 5) the repigmentation agent catalase (claims 1-19 and new claims 21-23 read on the elected species). Applicant’s election without traverse in the reply filed on 11/19/2025 is acknowledged.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 3, 4, 5, 10 and 11 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Pohlmann et al., hereinafter Pohlmann (US2015/0238406A1; published 27 August, 2015; reference provided in the IDS).
Pohlmann teaches pharmaceutical compositions for the treatment of alopecia, comprising polymeric nanoparticles, finasteride and additives for the topical application for treating alopecia (see Abstract). Hair loss, also called alopecia can manifest as irreversible scarring alopecia where there is a destruction of hair follicles or reversible alopecia [0002]. Currently the treatment can be topical or systemic [0007]. Pohlmann teaches colloidal drug delivery systems, specifically polymer nanoparticles formed by biodegradable polymers for improved therapeutic potential and stability during storage and upon contact with the body fluids [0009]. As shown in Fig 3, Pohlman teaches that treatment with finastride nanocapsules showed accelerated hair growth, which covered almost the entire back of the animals after 23 days [0103]. The results as taught by Pohlmann demonstrated the superiority of the formulation with finastride nanocapsules [0103] and demonstrate that topical formulation of finastride nanocapsules accelerates hair growth and development of follicles with a predisposition for androgenetic alopecia (Example 1.7 [0110]).
Claim 1 is directed to a method of treating, inhibiting, preventing hair loss, regrowing, thickening hair, comprising topically administering nanoparticle comprising at least one biodegradable polymer and at least one hair regrowth agent. The examiner interprets treating, inhibiting, preventing hair loss, regrowing, thickening hair as intended use and the disjunctive conjunction ‘or’ as a set of alternatives.
Pohlmann specifically teaches polymeric nanoparticles used to encapsulate finasteride for the treatment of alopecia [0024]. Finasteride is a synthetic azosteroid [0039] and patients taking this drug present reversal in alopecia symptoms [0039]. Pohlman teaches that the polymer used to encapsulate finastride is a hydrophobic polymer preferably a biodegradable polymer [0046]. Pohlmann teaches that the biodegradable hydrophobic polymer is selected from the group of polyesters, poly(lactide), poly (glycolide), copolymers of poly (lactide-co-glycolide), etc. [0046]. Pohlmann teaches that topical application of polymeric nanoparticle composition of finasteride avoids the disadvantages and side effects associated with systemic administration [0040]. As per Fig 3, Pohlmann teaches accelerated hair growth upon treatment with finasteride nanocapsules (NEF25) [0103].
Regarding claim 2, the Applicant elected finasteride as the hair regrowth agent.
Pohlmann specifically teaches polymeric nanoparticle comprising finasteride. The species search/examination was extended to the non-elected species minoxidil, for the purpose of compact prosecution. As noted, Pohlmann teaches active ingredient that promotes hair growth, and includes finasteride and minoxidil as one of those active ingredients [0015][0016][0039].
Regarding claim 3, the examiner interprets the disjunctive conjunction ‘or’ to present a set of alternatives.
Pohlmann specifically teaches polymeric nanoparticles for alopecia [0019][0039][0065][0001][0066] and androgenetic alopecia [0099].
Regarding claim 4, Pohlmann teaches that the pharmaceutical composition of polymeric nanoparticles for the treatment of alopecia optionally contains antioxidant [0026] [0067].
Regarding claim 5, Pohlmann teaches that the biodegradable polymer is selected from the group of polyesters, poly(lactide), poly (glycolide), copolymers of poly (lactide-co-glycolide), etc. [0046].
Claim 10 is directed to a method of claim 1 wherein nanoparticles are formulated by an emulsion solvent evaporation or solid-in-oil-in-water emulsion method.
Pohlmann teaches a primary emulsion of nanocapsules wherein polymer is solubilized in the organic phase along with finasteride, triglycerides of capric acid and caprylic and low HLB surfactant (sorbitan monostearate) under moderate heating between 20° C and 40° C preferably at 40° C, employing acetone as solvent. The neutral surfactant (polysorbate 80) is dissolved in water to form the aqueous phase. After dissolution of all components of the organic phase and aqueous phases, the
organic phase is injected, using a funnel, over the aqueous phase. Pohlmann teaches that the emulsion is maintained under moderate agitation for 10 min and then concentrated to a final volume of 100 ml in a rotary evaporator [0071].
Regarding claim 11, Pohlmann teaches biodegradable polymer selected from the group of polyesters, poly(lactide), poly (glycolide), copolymers of poly (lactide-co-glycolide), etc. [0046].
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.
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.
Claims 6, 7, 8, 9, 12, 13, 14, 15, 16, 22, 23 are rejected under 35 U.S.C. 103 as being unpatentable over Pohlmann et al., hereinafter Pohlmann (US2015/0238406A1; published 27 August, 2015; reference provided in the IDS) as applied to claims 1 and 11 above and in further view of Gupta, Shyam hereinafter Gupta (US2007/0166255A1; published 19 July, 2007; reference provided in the IDS).
Claims 6, 7, 8, 9, 12-15 are directed to polymeric nanoparticles comprising plasticizer, wherein the plasticizer is dimethyl tartrate, and surfactant or emulsifier, wherein surfactant or emulsifier is polyvinyl alcohol.
Claims 16, 22 and 23 are directed to polymeric nanoparticles comprising hair regrowth agent wherein hair regrowth agent is finasteride.
Pohlmann teaches pharmaceutical composition for the topical treatment of alopecia, said composition comprising polymeric nanoparticles containing finasteride [0019]. Pohlmann teaches that the polymer used to encapsulate the finasteride is preferably a biodegradable hydrophobic polymer selected from the group of polyesters, poly (lactide), poly (glycolide), copolymers of poly (lactide-co-glycolide), etc [0046]. As shown in Fig 3, Pohlman teaches that treatment with finastride nanocapsules showed accelerated hair growth, which covered almost the entire back of the animals after 23 days [0103]. The results as taught by Pohlmann demonstrated the superiority of the formulation with finastride nanocapsules [0103] and demonstrate that topical formulation of finastride nanocapsules accelerates hair growth and development of follicles with a predisposition for androgenetic alopecia (Example 1.7 [0110]). Pohlmann teaches that the pharmaceutical composition of polymeric nanoparticles optionally contains additives such as dispersants, surfactants, moisturizing agents, emollients, thickeners, sequestering agents, preservatives, antioxidants, fragrances and the like [0067].
Pohlmann does not teach plasticizer is dimethyl tartrate and surfactant is polyvinyl alcohol.
Gupta teaches compositions and methodology for topical application based on certain natural lignins [0002]. Gupta teaches that certain lignans, when applied topically in combination with a novel method of dermal penetration, provide treatment for ailments…and hair loss [0066]. Gupta teaches diethyl tartrate, dimethyl tartrate as penetration-enhancing agents for topical benefit [0067][0075]. Gupta teaches polyvinyl alcohol in the topical compositions as rheological modifiers [0174].
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the polymeric nanoparticle of Pohlmann comprising surfactant, and introduce the surfactant polyvinyl alcohol, as taught in Gupta in the instant application. Notably, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the polymeric nanoparticle of Pohlmann to introduce dimethyl tartrate as penetration-enhancing agents for topical benefit [0067][0075]. One motivated to do so would have a reasonable expectation of success as Pohlmann explicitly teaches surfactants in the polymeric nanoparticle compositions [0067]. Pohlmann teaches that owing to low permeability of some drugs through the keratin layer, only a fraction of the applied dose reaches the site of action, penetrating the pores and hair follicles [0012]. Thus, one would have recognized that applying the teaching of Pohlmann and modifying with penetration-enhancing agent dimethyl tartrate as taught by Gupta, would have yielded predictable results and improved the desired function of the composition (See MPEP § 2143 I(A)(D)).
Claims 17, 18, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Pohlmann et al., hereinafter Pohlmann (US2015/0238406A1; published 27 August, 2015; reference provided in the IDS) as applied claim 1 above and further in view of Burnison, Chantal, hereinafter Chantal (WO2015/155609A2; published 15 October, 2015).
Claims 17, 18 and 19 are directed to the method of claim 1 further comprising administering at least one repigmentation agent wherein the repigmentation agent is an antioxidant wherein said antioxidant is catalase.
Pohlmann teaches topical treatment of alopecia (Fig 3, Fig 8), comprising polymeric nanoparticles containing finasteride [0019]. Pohlmann teaches that the polymer used to encapsulate the finasteride is preferably a biodegradable hydrophobic polymer selected from the group of polyesters, poly (lactide), poly (glycolide), copolymers of poly (lactide-co-glycolide), etc [0046]. Pohlmann teaches that treatment with finasteride nanocapsules (NF25) led to abundant terminal follicles due to the strong presence of melanin [0107] and decreased the presence of follicles with little pigmentation [0108]. Pohlmann teaches that the pharmaceutical composition of polymeric nanoparticles optionally contains additives such as dispersants, surfactants, moisturizing agents, emollients, thickeners, sequestering agents, preservatives, antioxidants, fragrances and the like [0067].
Pohlmann does not teach the antioxidant is catalase.
Chantal teaches compositions that enhance hair growth in a subject (see page 3, line 28) comprising minoxidil, lower alkyl-substituted bicycloalkane and optionally P. sativum sprout extract sufficient to increase the growth of eyelashes and/or eyebrows (see page 4, line 5). In certain embodiments, the compositions provide topical formulations for enhancing the eyelashes and/or eyebrows of a subject (see page 4, line 21). Chantal teaches that the composition includes one or more additional ingredients such as biotin, hair dye, catalase, solvents, thickeners, gelling agents, coloring materials, fillers, pigments, antioxidants, preservatives, fragrances, electrolytes, neutralizing agents, polymers, UV blocking agents and combinations thereof (see page 9, line 1). Chantal teaches that to address concerns of greying hair and restore natural pigmentation, the composition includes catalase (see page 5, line 26; page 9, line 13; Example VI).
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the polymeric nanoparticle comprising antioxidant, as taught in Pohlmann, and introduce catalase, as taught in Chantal in the instant application. Notably, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the polymeric nanoparticle of Pohlmann to address concerns of greying and restoring natural pigmentation (In Chantal: see page 5, line 26; page 9, line 13; Example VI). One motivated to do so would have a reasonable expectation of success as Pohlmann explicitly teaches that treatment with finasteride nanocapsules (NF25) leads to abundant terminal follicles due to the strong presence of melanin [0107] and the decreased presence of follicles with little pigmentation [0108]. Thus, one would have recognized that applying the teaching of Pohlmann and modifying with antioxidant catalase as taught by Chantal, would have yielded predictable results and improved the desired function of the composition (See MPEP § 2143 I(A)(D)).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Pohlmann et al., hereinafter Pohlmann (US2015/0238406A1; published 27 August, 2015; reference provided in the IDS) as applied to claims 1 and 17-19 above and in further view of Masoud Ali Karami et al., hereinafter Masoud (KARAMI, M. A., JALILI RAD, M., ZADEH, B. S. M., & SALIMI, A. (2019). SUPEROXIDE DISMUTASE LOADED NIOSOMES DELIVERY TO HAIR FOLLICLES: PERMEATION THROUGH SYNTHETIC MEMBRANE AND GUINEA PIG SKIN. International Journal of Applied Pharmaceutics, 11(5), 305–312; published 07-09-2019) further in view of Burnison, Chantal, hereinafter Chantal (WO2015/155609A2; published 15 October, 2015).
Claim 21 is directed to the method of claim 19 further comprising administering superoxide dismutase (SOD).
Pohlmann teaches topical treatment of alopecia (Fig 3, Fig 8), comprising polymeric nanoparticles containing finasteride [0019]. Pohlmann teaches that treatment with finasteride nanocapsules (NF25) led to abundant terminal follicles due to the strong presence of melanin [0107] and decreased the presence of follicles with little pigmentation [0108]. Pohlmann teaches that the pharmaceutical composition of polymeric nanoparticles optionally contains additives such as dispersants, surfactants, moisturizing agents, emollients, thickeners, sequestering agents, preservatives, antioxidants, fragrances and the like [0067].
Pohlmann does not teach the antioxidant is catalase.
Chantal teaches compositions that enhance hair growth in a subject (see page 3, line 28). Chantal teaches that the composition includes one or more additional ingredients such as biotin, hair dye, catalase, solvents, thickeners, gelling agents, coloring materials, fillers, pigments, antioxidants, preservatives, fragrances, electrolytes, neutralizing agents, polymers, UV blocking agents and combinations thereof (see page 9, line 1). Chantal teaches that to address concerns of greying hair and restore natural pigmentation, the composition includes catalase (see page 5, line 26; page 9, line 13; Example VI).
Pohlmann and Chantal do not teach superoxide dismutase.
Masoud teaches that alopecia aretea is associated with increase in free radicals causing damage to hair follicles. Superoxide dismutase (SOD) with sufficient penetration through hair follicles can prevent their death by its strong antioxidant effects (see Abstract).
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the polymeric nanoparticle comprising antioxidant, as taught in Pohlmann, introduce catalase, as taught in Chantal and SOD as taught by Masoud in the instant application. Notably, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the polymeric nanoparticle of Pohlmann to address concerns restoring natural pigmentation (In Chantal: see page 5, line 26; page 9, line 13; Example VI) and reduce free radical damage of hair follicles as taught by Masoud. One motivated to do so would have a reasonable expectation of success as Pohlmann explicitly teaches treatment with finasteride nanocapsules (NF25) and additives [0067]. Thus, one would have recognized that applying the teaching of Pohlmann and modifying with antioxidant catalase as taught by Chantal, and SOD as taught in Masoud, would have yielded predictable results and improved the desired function of the composition (See MPEP § 2143 I(A)(D)).
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 1-9 and 11-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 7, 8, 9, 10, 14, 15 (see claim listing filed on 10/28/2025) of copending Application No. 18/287,762 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference application claims (Application No. 18/287,762):
Claim 1 (Original): A nanoparticle comprising cyclosporine, a biodegradable polymer, a surfactant emulsifier, and a plasticizer.
Claims 2-5 (Cancelled)
Claim 6 (Previously Presented): A composition comprising the nanoparticle of claim 1 and a pharmaceutically acceptable carrier.
Claim 7 (Previously Presented): A method of treating, inhibiting, and/or preventing hair loss and/or regrowing and/or thickening hair in a subject in need thereof, said method comprising topically administering the nanoparticle of claim 1 to the skin of the subject.
Claim 8 (Original): The method of claim 7, wherein said hair loss is caused by alopecia, alopecia areata, androgenetic alopecia, hypotrichosis, or hair miniaturization.
Claim 9 (Original): The method of claim 7, further comprising administering at least one other hair regrowth agent or at least one antioxidant.
Claim 10 (Currently Amended): A method of treating, inhibiting, and/or preventing psoriasis in a subject in need thereof, said method comprising topically administering a tho nanoparticle of claim 1 to the skin of the subject, wherein said nanoparticle comprises cyclosporine, a biodegradable polymer, a surfactant emulsifier, and a plasticizer.
Claim 11 (Previously Presented): A method of treating, inhibiting, and/or preventing arthritis in a subject in need thereof, said method comprising topically administering the nanoparticle of claim 1 to the skin of the subject.
Claim 12 (Previously Presented): A method of treating, inhibiting, and/or preventing dry eye disease in a subject in need thereof, said method comprising administering the nanoparticle of claim 1 to the eye of the subject.
Claim 13 (New): The method of claim 10, wherein said biodegradable polymer is poly-lactic-co-glycolic acid.
Claim 14 (New): The method of claim 10, wherein said plasticizer is dimethyl tartrate.
Claim 15 (New): The method of claim 10, wherein said emulsifier is polyvinyl alcohol.
Claim 16 (New): The method of claim 10, wherein said nanoparticle comprises cyclosporine, poly-lactic-co-glycolic acid, dimethyl tartrate, and polyvinyl alcohol.
Claim 17 (New): The method of claim 10, wherein said nanoparticle has a diameter up to 350 nm.
Claim 18 (New): The method of claim 10, wherein said psoriasis is plaque psoriasis.
Claim 19 (New): The method of claim 18, wherein said plaque psoriasis is severe.
In the instant application, claim 1 is directed to polymeric nanoparticles wherein the polymeric nanoparticles comprise at least one biodegradable polymer and at least one hair regrowth agent. This is a generic claim and encompasses the genus of polymeric nanoparticles. Reference claim is directed to a species or sub-genus of polymeric nanoparticles. Here, the entire scope of the reference claim falls within the scope of the examined claim. Therefore, a patent to the genus of polymeric nanoparticles would improperly extend the right to exclude granted by a patent to the species or sub-genus, should the genus issue as a patent after the species or sub-genus. See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 1052, 29 USPQ2d 2010, 2015-16 (Fed. Cir. 1993). See claims 1, 7 and 11 in the reference application.
Regarding claim 2, the hair regrowth agent is minoxidil, finasteride, cyclosporine-A, a Janus kinase (JAK) inhibitor, or bimatoprost. Reference application claims nanoparticle comprising cyclosporine. See claim 1 in the reference application.
Regarding claim 3, hair loss is caused by alopecia, alopecia areata, androgenetic alopecia, hypotrichosis, or hair miniaturization. Reference application claims alopecia, alopecia areata, androgenetic alopecia, hypotrichosis, or hair miniaturization. See claim 8 in the reference application.
Regarding claim 4, reference application claims regrowth agent or plasticizer. See claim 9 in the reference application.
Regarding claim 5, reference application claims a biodegradable polymer. See claim 1 in the reference application.
Regarding claim 6, the nanoparticle further comprises at least one plasticizer. Reference application claims nanoparticle comprising plasticizer. See claim 1 in the reference application.
Regarding claims 7, reference patent claims plasticizer is dimethyl tartrate. See claim 14 in the reference application.
Regarding claim 8, the reference application claims surfactant or emulsifier. See claim 1 and 10 in the reference application.
Regarding claim 9, reference application claims polyvinyl alcohol. See claim 15 in the reference application.
Regarding claims 11-15, reference application claims biodegradable polymer (see claim 1 in reference application), plasticizer (see claims 1 and 10 in reference application), dimethyl tartrate (see claim 14 in reference application), surfactant or emulsifier (see claims 1 and 10 in reference application)
The application depends on the inherent property of the polymeric nanoparticle. See
MPEP § 2112. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a
scientific explanation for the prior art’s functioning, does not render the old composition patentably
new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947
(Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently
present in the prior art does not necessarily make the claim patentable. Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct
claims have not in fact been patented.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
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/ARCHANA VARADARAJ/Examiner, Art Unit 1658 /LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654