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 .
Applicant’s claim amendment submitted on July 13, 2026, have been fully considered. All previous claim rejections of the Office action dated July 13, 2026, have been withdrawn in view of the amendment made to claim 6, which limits the present method to a method for improving hair quality, selected from the group consisting of increasing hair thickness, hair cuticle alignment, and reducing the number or rate of white hairs and/or increasing anagen-stage hairs in a subject.
New rejections have been made to address the amended claims.
Claim Rejections - 35 USC § 102
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.
Claims 6 and 8-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mirmirani et al. (“Linchen planopilaris treated with a peroxisome proliferator – activated receptor y agonist”, Arch Dermatol. December 2009; 145 (12): 1363-1366, cited in IDS) (“Mirmirani” hereunder).
The amended claim 1 is directed to a method for improving hair quality, selected from the group consisting of increasing hair thickness, hair cuticle alignment, and reducing the number or rate of white hairs and/or increasing anagen-stage hairs in a subject, the method comprising: administering pioglitazone to the subject.
Mirmirani discloses a study in which a patient suffering from lichen planopilaris, a permanent hair loss condition, was treated with oral pioglitazone hydrochloride. See abstract. A scalp biopsy performed after 6 months of the therapy showed a significant decrease in inflammation and further hair loss.
It is well settled in patent law that the discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. See MPEP 2112.02, II. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978). In this case, applicant is claiming using an old composition comprising pioglitazone to improve the hair quality of a subject. Although Mirmirani does not specifically describe “increasing hair thickness, hair cuticle alignment, and reducing the number or rate of white hairs and/or increasing anagen-stage hairs” these are no more than the results of administering the drug. Since Mirmirani discloses the same method of administering the same compound to a subject, the present claim is anticipated.
Regarding claim 9, the observation and evaluation of the decreased hair loss meets the method step of “testing the hair volume or quality”.
Regarding claim 10, the observation and evaluation of the significant decrease in inflammation of the scalp biopsy in the study meets the method step of testing to determine whether the tissue repair was accelerated. The “increased of M2 macrophage and increase of PPARץ expression” as in claim 10 must have naturally occurred in the patient in the study who was treated with the same compound for the same purpose of improving hair quality.
Regarding claim 11, the reference teaches that the scalp biopsy was performed after 6 months of therapy and that the patient has continued taking oral pioglitazone for 2 more months.
Claims 6 and 8-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peterson et al. (“Response of Lichen Planopilaris to Pioglitazone Hydrochloride”, J Drugs Derm., Dec 2019, vol. 18, no 12, p 1276-1279, cited in IDS) (“Peterson” hereunder).
Peterson reports that patients suffering from lichen planopilaris were treated with oral pioglitazone hydrochloride in the amount of 15-30 mg/d, which resulted in reducing symptoms and inflammation. See Method.
Applicant is claiming using an old composition comprising pioglitazone for administering to a subject to improve hair quality, and the present process claim is directed to the result of administering the drug. Since Peterson discloses the same method of administering the same compound to a subject, the present claim is anticipated. See claims 6 and 8.
Regarding claim 9, the observation and evaluation of the decreased further hair loss meets the testing the hair volume or quality.
Regarding claim 10, the observation and evaluation of the significant decrease in inflammation of the scalp biopsy in the study meets the method step of testing to determine whether the tissue repair was accelerated. The “increased of M2 macrophage and increase of PPARץ expression” as in claim 10 must have naturally occurred in the patient in the study who was treated with the same compound for the same purpose of improving hair volume and quality.
Regarding claim 11, Peterson teaches that the improvement of the symptoms as noted in Table 1 was noted after 4 months after the initiation of the trial, and the treatment continued during the total duration of 10.68 months.
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Mirmirani as applied to claims 6 and 8-11 as above, and further in view of the teachings of the same reference.
Mirmirani suggests topical administration of thiazolidinediones to treat hair loss. See p. 3, last line. The reference concludes, “given the experimental evidence for the role of PPAR-y in LPP and the positive clinical and histologic effects of pioglitazone in this patient, studies evaluating the efficacy of thiazolidinediones, either orally or topically, may be advocated for LPP.” Based on such teaching and suggestion, one of ordinary skill in the art before the effective filing date of the present application would have been obviously motivated to develop and prescribe topical application of pioglitazone to LPP patients with a reasonable expectation to successfully improving hair volume and quality.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Mirmirani as applied to claims 6 and 8-11 as above, and further in view of Wizel (US 2003/0139603 A1, published on July 24, 2003).
Although Mirmirani does not specifically disclose a method of preparing the pioglitazone composition, the oral dosage form of the drug is well known. Wizel teaches that 15 mg oral pioglitazone has been marketed as a tablet under the commercial name ACTOS and formulated with excipients including lactose monohydrate, hydroxypropylcellulose, etc. See [0066]. Thus, one of ordinary skill in the art before the effective filing date of the present application would have found it obvious to make pioglitazone oral dosage forms suitable for the treatment to improve hair volume and quality with a reasonable expectation of success.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Peterson as applied to claims 6 and 8-11 as above, and further in view of Wizel.
Although Peterson does not specifically disclose a method of preparing the pioglitazone composition, the oral dosage form of the drug is well known. Wizel teaches that 15 mg oral pioglitazone has been marketed as a tablet under ACTOS and formulated with excipients including lactose monohydrate, hydroxypropylcellulose, etc. See [0066]. Thus, one of ordinary skill in the art before the effective filing date of the present application would have found it obvious to make pioglitazone oral dosage forms suitable for the treatment to improve hair volume and quality with a reasonable expectation of success.
Claims 6, 7, 9, 10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Landreth et al. (US 20120115912 A1, published on May 10, 2012, cited in IDS) (“Landreth” hereunder).
Landreth teaches a method of treating dermatological diseases and/or disorders
where lipid PPARץ-regulated gene expression is decreased (e.g., lichen planopilaris). The paragraph [0434] specifically states:
[0434] In an example of the present invention, a pharmaceutical composition comprising a thiazolidinedione, such as rosiglitazone and/or pioglitazone, and Bexarotene can be topically administered to treat a subject having a primary CA, such as LPP. A topical formulation comprising a thiazolidinedione and Bexarotene may be prepared in a gel or liquid, for example, and then administered to at least one region of the subject affected by LPP. For example, the topical formulation may be administered to a portion of the subject's scalp exhibiting shiny, flat-topped bumps having an angular shape and a reddish-purplish color,
[0435] Administering the topical formulation to the affected region may inhibit or decrease peroxisome loss in at least one cell, such as in a sebaceous stem cell, by increasing expression of the PEX genes and/or genes associated with lipid β-oxidation and desaturation. This, in turn, may decrease or inhibit lipid accumulation in the pilosebaceous unit and thereby channel the lipid stores to increase β-oxidation and abrogate the deleterious effects of lipid overload, i.e., inflammation, loss of hair follicles, and fibrosis.
Since Landreth teaches a method of treating alopecia and lichen planopilaris with topical application of gel or liquid comprising thiazolidinedione such as pioglitazone, one of ordinary skill in the art would have been obviously motivated to do so with a reasonable expectation of successfully stopping hair loss and improving hair volume. See present claim 13.
Regarding claims 6 and 7, applicant is claiming using an old composition comprising pioglitazone for administering to a subject to improve hair quality, and the present process claim is directed to the result of administering the drug. Since Landreth discloses the same method of administering the same compound to a subject, the present claim is anticipated.
Regarding claims 9 and 10, observation and evaluation of efficacy of a treatment is an obvious process during the treatment period. The “increased of M2 macrophage and increase of PPARץ expression” as in claim 10 must naturally occur in the patient undergoing the treatment using the same PPARץ agonist compound.
Response to Arguments
Applicant’s arguments with filed on July 13, 2026, have been considered but are moot in view of the new grounds of rejections.
Conclusion
No claims are 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.
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/GINA C JUSTICE/Primary Examiner, Art Unit 1617
