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 .
Status of Claims
The amendments and arguments filed on 05/26/2026 are acknowledged and have been fully
considered. Claims 5-7, 12-15 is cancelled. Claims 1, 2, 16 and 22 are currently amended. Claims 1-4, 8-11, 16-19, 21-27 are now pending and will be examined on the merits herein.
Objections/Rejections Withdrawn
Objections and/or rejections not reiterated from previous Office Action are hereby withdrawn.
The following rejections and/or objections are either reiterated or newly applied, and constitute the
complete set presently being applied to the instant application.
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 1-4, 8-11, 16, 22-27 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) in view of Gupta, Shyam hereinafter Gupta (US2007/0166255A1; published 19 July, 2007; reference provided in the IDS) evidenced by Robert Gensure (Alopecia, 2018).
Regarding claim 1, Pohlmann teaches pharmaceutical composition for the topical treatment of alopecia, said composition comprising polymeric nanoparticles containing finasteride [0019] (i.e. hair regrowth agent). 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 dimethyl tartrate.
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].
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 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)).
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 and JAKi, 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]. Additionally, JAK inhibitors are used in the treatment of Alopecia as evidenced by Robert Gensure.
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 8, Pohlmann teaches emulsifier or surfactant ([0018], line 6).
Regarding claim 9, Pohlmann does not teach 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 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. 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 rheological modifier polyvinyl alcohol, as taught by Gupta, would have yielded predictable results and improved the desired function of the composition (See MPEP § 2143 I(A)(D)).
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].
Regarding claim 16, the obviousness rationale and rejection under claim 1 is noted above.
Regarding claim 22, the obviousness rationale and rejection under claim 9 has been noted above.
Regarding claim 23, the obviousness rationale and rejection under claim 9 has been noted above.
Regarding claim 24, 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)).
Regarding claim 25, the obviousness rationale has been noted above in claim 24.
Regarding claim 26, Pohlmann does not teach tofacitinib or ruxolitinib.
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 hair regrowth agent and use ruxolitinib as evidenced by Robert Gensure. 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 and add ruxolitinib. One motivated to do so would have a reasonable expectation of success as Robert Gensure explicitly teaches ruxolitinib and tofacitinib for the treatment of Alopecia (see section 2.7). Thus, one would have recognized that applying the teaching of Pohlmann and modifying with JAK inhibitors ruxolitinib and tofacitinib, would have yielded predictable results and improved the desired function of the composition (See MPEP § 2143 I(A)(D)).
Regarding claim 27, Pohlmann teaches nanoparticle with average diameter of 222±3 nm (see Table 3, page 13) i.e. between 150 nm and 350 nm.
Claims 1, 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) in view of Gupta, Shyam hereinafter Gupta (US2007/0166255A1; published 19 July, 2007; reference provided in the IDS) further in view of Burnison, Chantal, hereinafter Chantal (WO2015/155609A2; published 15 October, 2015).
The teachings of Pohlmann and Gupta have been set forth above.
Additionally, regarding claim 17, 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 (i.e. repigmentation agent), fragrances and the like [0067].
Regarding claim 18, Pohlmann teaches antioxidant [0067].
Regarding claim 19, Pohlmann and Gupta do 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)).
Claims 1, 17, 18, 19, 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) in view of Gupta, Shyam hereinafter Gupta (US2007/0166255A1; published 19 July, 2007; reference provided in the IDS) 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).
The teachings of Pohlmann, Gupta and Chantel have been noted above.
Additionally, regarding claim 21, Pohlmann teaches that the pharmaceutical composition of polymeric nanoparticles contains additives such as antioxidants [0067].
Pohlmann, Gupta and Chantel 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 1-4, 8-11, 16-19, 21-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10, 13, 14, 15, 16, 17, 20 (see claim listing filed on 05/26/2026) of copending Application No. 18/287,762 (reference application) evidenced by Nathan J. Hawkshaw et al., hereinafter Hawkshaw (Nathan J. Hawkshaw et al., Journal of Investigative Dermatology, Volume 135, Issue 8, 2129-2132, August 2015). 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.
Regarding claim 1, reference application ‘762 teaches a method of treating comprising administering polymeric nanoparticles wherein the polymeric nanoparticles comprise at least one biodegradable polymer; at least one hair regrowth agent i.e. cyclosporin, as evidenced by Hawkshaw; emulsifier and plasticizer. Embodiments of the specification in ‘762, disclose dimethyl tartrate (see page 2, line 1) and polylactide-co-glycolide (see page 1, line 34).
Regarding claim 2, reference application ‘762 teaches a composition comprising biodegradable polymer, emulsifier and plasticizer. This is a generic claim. Here the 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).
Regarding claim 3, reference application ‘762 teaches a method of treating, comprising nanoparticle administration for prevention of psoriasis. In this case, the limitation at issue, is the natural result of the composition, explicitly disclosed by the instant claim “ Id. At 1195- 96, 112 USPQ2d at 1952. But see, Persion Pharms. LLC v. Alvogen Malta Operations LTD., 945 F.3d 1184, 1191, 2019 USPQ2d 494084 (Fed. Cir. 2019), where the court stated that a proper finding of inherency does not require that all limitations are taught in a single reference, and that inherency may meet a missing claim limitation when the limitation is “the natural result of the combination of prior art elements.” (see MPEP §2112 .IV). Additionally, it is noted “the 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. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Regarding claim 4, reference application ‘762 teaches cyclosporine (i.e. hair regrowth agent).
Regarding claim 8, the reference application ‘762 teaches surfactant or emulsifier. See claim 10.
Regarding claim 9, reference application ‘762 teaches polyvinyl alcohol. See claim 15.
Regarding claim 10, reference application ‘762 teaches nanoparticles. Embodiments of the specification in the reference application disclose solid-in-oil-in-water emulsion method (see page 8, line 6).
Regarding claim 11, reference application ‘762 teaches poly (DL-lactide-co-glycolide). See claim 10.
Regarding claim 16, reference application ‘762 teaches cyclosporine (i.e. hair regrowth agent). Reference application does not teach finasteride. 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 cyclosporine and use finasteride as the hair regrowth agent. One motivated to do so would have a reasonable expectation of success as instant claims teach hair regrowth agent. Thus, one would have recognized that applying the teaching of the reference application ‘762 and modifying with finasteride would have yielded predictable results and improved the desired function of the composition (See MPEP § 2143 I(A)(D)).
Regarding claims 17-19, 21, reference application ‘762 teaches a nanoparticle composition comprising biodegradable polymer, emulsifier and plasticizer. This is a generic claim. Here the 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). Embodiments in the specification of the reference application ‘762 teach catalase (see page 15, line 18), antioxidant(see page 15, line 12), SOD (see page 15, line 18).
Regarding claim 22, reference application ‘762 teaches a composition comprising biodegradable polymer, emulsifier and plasticizer. This is a generic claim. Embodiments in the specification of the reference application ‘762 teach finasteride (see page 14, line 34) and poly vinyl alcohol (see page 6, line 12).
Regarding claim 23, the rejection under claim 22 has been noted above.
Regarding claim 24, the rejection under claim 1 and 22 have been noted above.
Regarding claim 25, the rejection under claim 24 has been noted above.
Regarding claim 26, reference application teaches the nanoparticle composition. Embodiments in the specification of the reference application ‘762 teach ruxilitinib (see page 15, line 1).
Regarding claim 27, reference application teaches the nanoparticle composition. Embodiments in the specification of the reference application ‘762 teach particle diameter of 220 nm (see page 16, line 17) (i.e. 150 nm -350 nm).
Response to Arguments
Applicant's arguments filed 05/26/2026 have been fully considered but they are not persuasive.
Applicant argues that Pohlmann et al. describe nanoparticles comprising a hydrophobic homopolymer and only describe methods of making nanoparticles with a hydrophobic homopolymer. Moreover, Pohlmann et al. directly teach away from using an amphiphilic block copolymer at paragraph [0018]. The rejection of record was that it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use poly lactide-co-glycolide. The motivation of the claimed improvements, i.e., the use of an amphiphilic polymer in the formation of nanoparticles containing an active ingredient, is to reduce the colloidal instability which causes the precipitation or flocculation that occurs when a hydrophobic polymer is used in the preparation of nanoparticles. (see Pohlmann [0016]). "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)).
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).
Applicant argues that Gupta teaches dimethyl tartrate but does not teach dimethyl tartrate is a ‘solubilizing-penetration enhancing agent’. The MPEP states that the selection of known materials based on their suitability for their intended uses is prima facie obvious. See MPEP § 2144.07. "Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at 301.).
Applicant argues that Burnison et al., and Karami et al., clearly fails to overcome the
deficiencies in the teachings of Pohlmann et al. and Gupta et al. However, the rejection of record was that it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use catalase and SOD, as Pohlmann specifically discloses antioxidants in the nanoparticle composition [0067].
Applicant argues that the instant application demonstrates unexpectedly superior properties with the claimed methods -nanoparticles of the instant invention cause unexpectedly superior hair growth in humans. The Examiner would like to remind the Applicant that the burden is on the Applicant to establish results are unexpected and significant. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). “[E]evidence of unexpected results must be weighed against evidence supporting prima
facie obviousness in making a final determination of the obviousness of the claimed invention. In re
May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978). Where the unexpected properties of a claimed
invention are not shown to have a significance equal to or greater than the expected properties, the
evidence of unexpected properties may not be sufficient to rebut the evidence of obviousness. In re
Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977). Expected beneficial results are evidence of
obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967) (resultant decrease of dental
enamel solubility accomplished by adding an acidic buffering agent to a fluoride containing dentifrice
was expected based on the teaching of the prior art); Ex parte Blanc, 13 USPQ2d 1383 (Bd. Pat. App. &
Inter. 1989).
Applicant argues that the reference application in the provisional non-statutory double patenting rejection is directed to treating psoriasis. Examiner would like to remind the Applicant that the natural result of the composition, explicitly disclosed by the instant claim “ Id. At 1195- 96, 112 USPQ2d at 1952. But see, Persion Pharms. LLC v. Alvogen Malta Operations LTD., 945 F.3d 1184, 1191, 2019 USPQ2d 494084 (Fed. Cir. 2019), where the court stated that a proper finding of inherency does not require that all limitations are taught in a single reference, and that inherency may meet a missing claim limitation when the limitation is “the natural result of the combination of prior art elements.” (see MPEP §2112 .IV). Additionally, it is noted “the 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. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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