The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 106-120 are presented for examination.
Acknowledgement is made of the instant application as a continuation of U.S. Patent Application No. 16/676,657, filed November 7, 2019, now U.S. Patent No. 11,311,529 B2, which claims benefit under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Nos. 62/757,483, filed November 8, 2018, and 62/889,318, filed August 20, 2019.
Requirement for Restriction/Election
Applicant’s election without traverse of (i) endocrine therapy-induced alopecia (ETIA) as the single disclosed species of condition of the human subject, (ii) dimethyl isosorbide as the single disclosed species of solvent, and (iii) stearalkonium chloride as the single disclosed species of emulsifier, to which examination on the merits will be confined, as stated in the reply filed February 3, 2026, is acknowledged by the Examiner.
Upon further reconsideration of the claimed subject matter, however, the required elections of condition, solvent and emulsifier are each now hereby withdrawn.
Accordingly, Applicant’s claims 106-120 are subject to examination and such claims are herein acted on the merits infra.
Information Disclosure Statement
Applicant’s Information Disclosure Statement filed October 5, 2022 (six pages total) has been received and entered into the present application. As reflected by the attached, completed copy of form PTO/SB/08, the Examiner has considered the cited references.
Priority
Acknowledgement is made of the instant application as a continuation of U.S. Patent Application No. 16/676,657, filed November 7, 2019, which claims benefit under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62/889,318, filed August 20, 2019, and U.S. Provisional Patent Application No. 62/757,483, filed November 8, 2018. The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original non-provisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. §112(a) or the first paragraph of pre-AIA 35 U.S.C. §112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.2d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of prior-filed U.S. Provisional Patent Application No. 62/757,483, filed November 8, 2018, fails to satisfy the requirements of 35 U.S.C. §112(a) or the first paragraph of pre-AIA 35 U.S.C. §112 for one or more claims of the instant application. Specifically, the ‘483 disclosure fails to provide adequate written support for the recited therapeutic objective of “stimulating hair growth on the scalp of a human subject”, wherein the human subject may be any subject (not necessarily one exhibiting hair loss or a condition associated with hair loss) (claim 106), or the specific topical dutasteride emulsion that comprises “diethyl sebacate and oleyl alcohol” (claim 106). Also, the ‘483 disclosure fails to provide adequate written support for the practice of the recited method in a human subject suffering from “alopecia areata” (claim 107), application to the scalp at the frontal, central or vertex regions, or a combination thereof (claim 109), that the topical composition further comprises a solvent or emulsifier of those specifically recited (claims 113-114), that the dutasteride is “dissolved in an oil phase” (claim 115), or that the composition comprises “a humectant, a thickener, a preservative, an emollient, an emulsifier, a pH adjuster, a penetration enhancer, and a conditioning agent” (claim 116).
Also, the disclosure of prior-filed U.S. Provisional Patent Application No. 62/889,318, filed August 20, 2019, fails to satisfy the requirements of 35 U.S.C. §112(a) or the first paragraph of pre-AIA 35 U.S.C. §112 for one or more claims of the instant application. Specifically, the ‘318 disclosure fails to provide adequate written support for the recited therapeutic objective of “stimulating hair growth on the scalp of a human subject”, wherein the human subject may be any subject (not necessarily one exhibiting hair loss or a condition associated with hair loss) (claim 106), or the specific application of the topical dutasteride composition to the scalp at the frontal, central or vertex regions, or a combination thereof (claim 109).
Accordingly, the effective filing date of claims 106 and 109-120 is November 7, 2019 (the filing date of the ‘657 application) and the effective filing date of claims 107-108 is August 20, 2019 (the filing date of the ‘318 provisional application).
The Examiner will revisit the issue of priority as necessary each time the claims are amended.
Objection to the Claims
Claim 109 is objected to for reciting “the frontal, central, vertex regions, or a combination thereof of the scalp”, which is grammatically awkward.
Appropriate correction is required.
Applicant may wish to consider amending the claim to recite ---the frontal, central, or vertex regions, or a combination thereof, of the scalp--- to obviate the instant objection, but is reminded that the adoption of such suggestion does not necessarily equate to the obviation of any other objection and/or rejection set forth infra.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
(1) Claims 106-107, 109, 112-113 and 115-116 are rejected under 35 U.S.C. 103 as being unpatentable over Kandavilli et al. (U.S. Patent Application Publication No. 2010/0048598 A1; 2010, cited by Applicant on the 10/05/22 IDS) in view of Munayyer et al. (U.S. Patent No. 5,422,361; 1995, cited by Applicant on the 10/05/22 IDS),
citing to Olsen et al. (“The Importance of Dual 5-Reductase Inhibition in the Treatment of Male Pattern Hair Loss: Results of a Randomized Placebo-Controlled Study of Dutasteride versus Finasteride”, J Am Acad Dermatol, 2006; 55:1014-1023, cited by Applicant on the 10/05/22 IDS) as factual evidence.
Kandavilli et al. teaches a pharmaceutical composition for improved topical delivery of the 5-reductase inhibitor dutasteride (or a salt, ester, isomer, solvate, hydrate or polymorph thereof) to deliver the inhibitor onto the skin, scalp, beneath the surface of the skin and/or scalp, and/or into the systemic circulation, which comprises the 5-reductase inhibitor with at least one pharmaceutically acceptable carrier, and optionally one or more other pharmaceutically acceptable excipients (p.2, para.[0014]-[0016]; p.2, para.[0031]; p.2, para.[0034]). Kandavilli et al. teaches that the pharmaceutical composition is therapeutically useful for the prophylaxis, amelioration and/or treatment of androgenic alopecia via administering to a subject in need thereof a prophylactically or therapeutically effective amount of the composition, wherein the function of inhibiting 5-reductase inhibits synthesis of dihydrotestosterone (DHT) - an androgenic compound that leads to androgenic (i.e., androgen dependent) alopecia in male or female humans (p.1, para.[0002]; p.2, para.[0026]; p.6, para.[0091]). Kandavilli et al. teaches that the formulation of dutasteride for application to the skin functions to enhance local bioavailability of dutasteride at the hair follicles, which is comparable in effect to an oral or injectable formulation of the 5-reductase inhibitor (p.2, para.[0028]; p.4, para.[0065]). Kandavilli et al. teaches that the rate of diffusion of the drug into the skin is such that a therapeutic concentration is achieved within about 0.5-8 hrs after topical application, and that a desirable drug level is maintained for an extended duration of time, such as for about 4-24 hrs (p.4, para.[0066]). Kandavilli et al. teaches that the topical 5-reductase inhibitor composition is applied directly to the skin surface for local or transdermal administration, and that the scalp is defined as the skin covering the head, bordered by the face anteriorly and the neck to the sides and posteriorly (p.3, para.[0040]).
Kandavilli et al. differs from the instant claims only insofar as it does not explicitly teach dutasteride in the form of an emulsion with diethyl sebacate or oleyl alcohol (claim 106).
Munayyer et al. teaches a physically and chemically stable oil-in-water emulsion for use in cream and lotion pharmaceutical compositions of lipophilic drugs, including steroids, in which the composition contains at least one lipophilic drug and an effective amount of N-methyl-2-pyrrolidone effective to enable penetration of the lipophilic drug through the skin (abstract; col.1, l.13-18, 56-61). Munayyer et al. teaches that the oil-in-water emulsion containing at least one lipophilic drug comprises (i) an amount of N-methyl-2-pyrrolidone effective to enable the lipophilic drug to penetrate the skin, (ii) an aqueous phase comprising water and an amount of propylene glycol sufficient to at least partially solubilize the lipophilic drug in the aqueous phase, (iii) an oil phase comprising an amount of mineral oil or diethyl sebacate effective to at least partially solubilize the lipophilic drug in the oil phase, (iv) a surfactant system effective to stabilize the emulsion formed from the oil phase and aqueous phase, (v) an occlusive agent, (vi) a preservative, and optionally, a silicone oil, wherein the pH of the base is in the range of 4.0-7.0 (col.2, l.2-18). Munayyer et al. teaches that the emulsion compositions may be used to treat skin conditions including scalp conditions, such as alopecia areata, in which application of lipophilic steroids directly to the scalp is effective (col.5, l.39-55).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in formulating the 5-reductase inhibitor dutasteride of Kandavilli et al. for the treatment of androgenic alopecia into the oil-in-water (O/W) emulsion of Munayyer et al. because Munayyer et al. teaches such O/W emulsion for formulating steroids into a topical cream or lotion for application to the skin, including the scalp skin. The skilled artisan would have been motivated to do so because Munayyer et al. teaches this O/W emulsion formulation for preparing topical steroids in a manner that facilitates penetration of the lipophilic drug (in this case, the steroid) through the skin to maximize its therapeutic effect. It would, therefore, 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 therapeutic method of applying dutasteride topically to the scalp skin for the treatment of androgenic alopecia as described by Kandavilli et al. by formulating dutasteride into the O/W emulsion of Munayyer et al. to enhance penetration of the active dutasteride to the scalp skin to treat hair loss.
As the topical O/W emulsion of Munayyer et al. comprises diethyl sebacate in the oil phase, wherein the lipophilic drug (in this case, dutasteride) is solubilized in the oil phase, such resultant emulsion meets the physical and structural requirements of Applicant’s claims 106 and 115.
The suggestion that such topical formulation of dutasteride be applied directly to the entire scalp – which necessarily includes any one of the frontal, central and/or vertex regions thereof - additionally meets Applicant’s limitations of claim 109.
Applicant’s recited preamble effect of “stimulating hair growth” and the effect of the topically applied amount and duration “to stimulate hair growth”, in which the “hair growth comprises an increase in scalp hair density, hair thickness, or scalp coverage” as recited in claim 106 is met by Kandavilli’s teachings, since Kandavilli et al. teaches that dutasteride functions as a 5a-reductase inhibitor – an effect that inhibits synthesis of DHT, the androgenic compound that leads to androgenic alopecia. The inhibition of DHT synthesis would have naturally interfered with the hyperandrogenic hair loss that occurs with androgenic alopecia, thereby slowing hair loss progression and increasing hair growth in the treated subject. The correlation of this effect of a 5a-reductase inhibitor to inhibit synthesis of DHT and stimulate hair growth is further documented by the extrinsic factual evidence to Olsen et al., which clearly teaches an inverse correlation between scalp DHT concentration after dutasteride therapy with target area hair count (col.2, para.2, p.1020-col.1, para.1, p.1021; Fig.5, p.1021)1.
Applicant should note that the stimulation of hair growth via increasing scalp hair count also constitutes an increase in “scalp hair density” and “hair thickness” as further recited in claim 106, since increasing the number of hairs in the scalp necessarily constitutes an overall increase in “hair density” and “hair thickness” as instantly claimed.
Claim 112 requires that the composition “does not contain polypropylene glycol”.
The topical O/W emulsion described by Munayyer et al. does not require polypropylene glycol as an element thereof, thereby meeting the limitations of Applicant’s claim 112.
Claim 113 requires that the topical composition comprises a solvent, e.g., sterile water, propylene glycol, etc.
Munayyer et al. teaches an O/W emulsion containing an aqueous phase in which water and propylene glycol are present in an amount sufficient to at least partially solubilize the lipophilic drug (in this case, the steroid dutasteride) in the aqueous phase, thereby meeting the limitations of Applicant’s claim 113.
Claim 116 requires that the composition further comprise, e.g., a preservative, an emulsifier, a penetration enhancer, etc.
The O/W emulsion of Munayyer et al. utilizes N-methyl-2-pyrrolidone as a penetration enhancer, a surfactant that stabilizes the emulsion (i.e., an emulsifier), a preservative, and an occlusive agent (i.e., a conditioning agent), thereby meeting the limitations of Applicant’s claim 116.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
(2) Claims 110-111 and 117-120 are rejected under 35 U.S.C. 103 as being unpatentable over Kandavilli et al. (U.S. Patent Application Publication No. 2010/0048598 A1; 2010, cited by Applicant on the 10/05/22 IDS) in view of Munayyer et al. (U.S. Patent No. 5,422,361; 1995, cited by Applicant on the 10/05/22 IDS),
citing to Olsen et al. (“The Importance of Dual 5-Reductase Inhibition in the Treatment of Male Pattern Hair Loss: Results of a Randomized Placebo-Controlled Study of Dutasteride versus Finasteride”, J Am Acad Dermatol, 2006; 55:1014-1023, cited by Applicant on the 10/05/22 IDS) as factual evidence,
as applied above to claims 106-107, 109, 112-113 and 115-116,
further in view of Rajendar et al. (WO 2019/012353 A1; Published January 2019, Filed June 2018, cited by Applicant on the 10/05/22 IDS).
Kandavilli in view of Munayyer as applied above to claims 106-107, 109, 112-113 and 115-116.
Kandavilli in view of Munayyer differs from the instant claims only insofar as they do not explicitly teach incorporation of dutasteride into the topical emulsion in an amount of about 0.001-1% (w/w) (claim 110), about 0.075% (w/w) (claim 111), about 0.002-0.1% (w/w) (claim 117), about 0.025% (w/w) (claim 118), about 0.05% (w/w) (claim 119), or about 0.15% (w/w) (claim 120).
Rajendar et al. teaches a pharmaceutical composition for topical application to prevent hair loss and stimulate hair growth containing dutasteride, wherein the effects of preventing hair loss and stimulating hair growth are equal to or higher than that of conventional oral treatment agents (oral finasteride or oral dutasteride) even though the amount of dutasteride is much less than that of conventional oral treatment agents (p.5, l.4-14; p.6, l.1-3). Rajendar et al. teaches that the dutasteride of the topical composition may be contained in the composition in an amount from about 0.001-0.5% (w/w), preferably about 0.01-0.1% (w/w), more preferably from about 0.01-0.06% (w/w), and most preferably 0.022% (w/w) of the composition (p.9, l.24-28).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in formulating the topical dutasteride emulsion formulation of Kandavilli et al. as modified by Munayyer et al. to contain dutasteride in an amount of about 0.001-0.5% (w/w) of the topical formulation because Rajendar et al. teaches topical dutasteride formulations for preventing hair loss and stimulating hair growth that contain about 0.001-0.5% (w/w) dutasteride. The skilled artisan would have been motivated to incorporate dutasteride into the topical emulsion of Kandavilli et al. as modified by Munayyer et al. in an amount of about 0.001-0.5% (w/w) because Rajendar et al. demonstrates that dutasteride was effectively incorporated into topical preparations for stimulating hair growth and preventing hair loss within this efficacious range. It would, therefore, 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 topical dutasteride emulsion of Kandavilli et al. in view of Munayyer et al. to incorporate dutasteride in an amount of about 0.001-0.5% (w/w), as such quantity of dutasteride was effective for use in topical dutasteride formulations for stimulating hair growth and preventing hair loss, as evidenced by Rajendar’s teachings.
The incorporation of about 0.001-0.5% (w/w) dutasteride constitutes a range that circumscribes and/or overlaps with Applicant’s instantly claimed values of “about 0.001% to about 1% (w/w)” (claim 110), “about 0.075% (w/w)” (claim 111), “about 0.002% to about 0.1% (w/w)” (claim 117), “about 0.025% (w/w)” (claim 118), “about 0.05% (w/w)” (claim 119), or “about 0.15% (w/w)” (claim 120), thereby rendering such instantly claimed values prima facie obvious. MPEP §2144.05 (“In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) … “[A] prior art reference that discloses a range encompassing a somewhat narrower range is sufficient to establish a prima facie case of obviousness.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005).”
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
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.
(3) Claims 106-113 and 116-120 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,311,556 B2.
Claim 1 of the ‘556 patent defines a dermis-targeting emulsion comprising:
(i) from 0.025% to 0.20% (w/w) dutasteride;
(ii) 3.0 + 0.15% (w/w) glycerin;
(iii) 4.0 + 0.20% (w/w) oleyl alcohol;
(iv) 20.45 + 1.0% (w/w) isopropyl myristate;
(v) 24.00 + 1.2% (w/w) diethyl sebacate;
(vi) 1.50 + 0.08% (w/w) steareth-2;
(vii) 2.00 + 0.1% (w/w) steareth-21;
(viii) 1.00 + 0.05% (w/w) cetearyl alcohol; and
(ix) water to 100% (w/w).
In the ‘529 disclosure, the patentee discloses that the emulsion is used in a method for ameliorating hair loss in the scalp of a human subject by (a) providing the inventive emulsion, and (b) topically applying the emulsion to the scalp of the subject in an amount and for a duration sufficient to ameliorate hair loss, wherein the amelioration of hair loss comprises an increase in scalp hair density, hair thickness or scalp coverage, and further wherein the emulsion is applied to the scalp in the frontal, central, or vertex regions, or a combination thereof (col.4, l.35-41, 46-48).
In the ‘529 disclosure, the patentee defines the human subject of the method as suffering from a condition selected from androgenetic alopecia, alopecia areata, or ETIA, in which the ETIA is hair loss secondary to endocrine therapy for breast cancer (col.4, l.41-46).
MPEP §804(II)(B)(1) clearly instructs that, “In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceutical Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).”
In claim 110, Applicant defines the amount of dutasteride as about 0.001% to about 1% (w/w).
In claim 111, Applicant defines the amount of dutasteride as about 0.075% (w/w).
In claim 117, Applicant defines the amount of dutasteride as about 0.002% to about 0.1% (w/w).
In claim 118, Applicant defines the amount of dutasteride as about 0.025% (w/w).
In claim 119, Applicant defines the amount of dutasteride as about 0.05% (w/w).
In claim 120, Applicant defines the amount of dutasteride as about 0.15% (w/w).
Claim 1 of the ‘556 patent provides for a dutasteride emulsion with 0.025% to 0.20% (w/w) dutasteride, which is a range that circumscribes and/or overlaps the ranges or amounts of claims 110-111 and 117-120. MPEP §2144.05 states, “In the case wherein the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) … “[A] prior art reference that discloses a range encompassing a somewhat narrower range is sufficient to establish a prima facie case of obviousness.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005).”
In claim 112, Applicant recites that the composition “does not contain polypropylene glycol”.
The emulsion of the ‘529 patent claim does not contain polypropylene glycol, thereby meeting this limitation of Applicant’s claim 112.
In claim 113, Applicant recites that the composition comprises a solvent, e.g., sterile water, glycerin, isopropyl myristate, etc.
The emulsion of the ‘529 patent claim contains various solvent components, including glycerin, isopropyl myristate, and water.
In claim 116, Applicant recites that the composition comprises a humectant, a thickener, a preservative, an emollient, a pH adjuster, a penetration enhancer, or a conditioning agent.
The emulsion of the ‘529 patent claim contains various components, such as glycerin, that constitute at least a thickener, emollient and/or conditioning agent.
This is a nonprovisional nonstatutory double patenting rejection.
(4) Claims 106-120 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,311,529 B2.
Claim 1 of the ‘529 patent is directed to a method for stimulating hair growth on a scalp of a human subject suffering from ETIA comprising:
a) providing a topical composition comprising a therapeutically effective amount of dutasteride dissolved in a topical pharmaceutically acceptable excipient or carrier, wherein the topical composition is an emulsion comprising diethyl sebacate and oleyl alcohol and does not contain ethyl alcohol; and
b) topically applying the composition to the scalp in an amount and for a duration sufficient to stimulate hair growth;
wherein hair growth comprises an increase in scalp hair density, hair thickness, or scalp coverage, which anticipates Applicant’s method of claims 106-107.
Claim 2 of the ‘529 patent defines the ETIA as hair loss secondary to endocrine therapy for breast cancer, which anticipates Applicant’s method of claim 108.
Claim 3 of the ‘529 patent requires application of the composition to the scalp at the frontal, central or vertex regions, or a combination thereof, which anticipates Applicant’s method of claim 109.
Claim 4 of the ‘529 patent defines the therapeutically amount of dutasteride as about 0.001% to about 1% (w/w), which anticipates Applicant’s method of claim 110.
Claim 5 of the ‘529 patent depends from claim 4 and further defines the therapeutically effective amount of dutasteride as about 0.075% (w/w), which anticipates Applicant’s method of claim 111.
Claim 6 of the ‘529 patent specifies that the composition does not contain polypropylene glycol, which anticipates Applicant’s method of claim 112.
Claim 7 of the ‘529 patent specifies that the composition further comprises a solvent selected from sterile water, glycerin, medium chain triglycerides, isopropyl myristate, diisopropyl adipate, isopropyl palmitate, propylene glycol, olive oil, castor oil, coconut oil, light mineral oil, diethylene glycol monoethylether, benzyl alcohol, cyclomethicone, PEG-400, dehydrated alcohol or dimethyl isosorbide, which anticipates Applicant’s method of claim 113.
Claim 8 of the ‘529 patent specifies that the composition further comprises an emulsifier selected from stearalkonium chloride, sodium monostearate, laureth-4, polysorbate 20, or PEG-35 castor oil, which anticipates Applicant’s method of claim 114.
Claim 9 of the ‘529 patent requires the dutasteride to be dissolved in the oil phase of the emulsion, which anticipates Applicant’s method of claim 115.
Claim 10 of the ‘529 patent specifies that the composition further comprises a humectant, thickener, preservative, emollient, emulsifier, pH adjuster, penetration enhancer, or conditioning agent, which anticipates Applicant’s method of claim 116.
Claim 11 of the ‘529 patent defines the therapeutically effective amount of dutasteride as about 0.002% to about 0.1% (w/w), which anticipates Applicant’s method of claim 117.
Claim 12 of the ‘529 patent defines the therapeutically effective amount of dutasteride as about 0.025% (w/w), which anticipates Applicant’s method of claim 118.
Claim 13 of the ’529 patent defines the therapeutically effective amount of dutasteride as about 0.05% (w/w), which anticipates Applicant’s method of claim 119.
Claim 14 of the ‘529 patent defines the therapeutically effective amount of dutasteride as about 0.15% (w/w), which anticipates Applicant’s method of claim 120.
This is a nonprovisional nonstatutory double patenting rejection.
Conclusion
Rejection of claims 106-120 is proper.
No claims of the present application are allowed.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
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/Leslie A. Royds Draper/Primary Examiner, Art Unit 1629
February 19, 2026
1 Despite the fact that Olsen’s study focuses on the oral administration of dutasteride, the physiological correlation between scalp DHT and hair count would have necessarily applied to Kandavilli’s topical dutasteride therapy, since Kandavilli et al. clearly teaches topical application of the dutasteride formulations directly to the scalp skin, which would have had the same effect of penetrating the scalp skin and reducing synthesis of DHT in the scalp via inhibition of 5a-reductase. Therefore, the manner in which the dutasteride is applied is peripheral – the fact remains that dutasteride functions to inhibit DHT via inhibition of 5a-reductase, and this reduction in serum DHT in the body – including locally at the scalp – would have necessarily correlated to an increase in hair count, thereby meeting Applicant’s claimed effect of “stimulating hair growth” or increasing “scalp hair density”, “hair thickness” or “scalp coverage” as instantly claimed.