DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group II (claims 6-11 and 13) in the reply filed on November 24, 2025 is acknowledged. The traversal is on the grounds that 1) allegedly “no indication was provided” that the Office has interpreted the claims in light of the specification; 2) Groups I and II have a technical relationship that involves the same special technical features; and 3) the Office has not shown any serious burden in examining all inventions. This is not found persuasive because 1) the Office has explained that all claim limitations of claim 1, or the general inventive features between Groups I and II, are disclosed in the cited reference (US 200301339603 A1) and therefore lacks special technical feature, and applicant fails to explain why the examiner’s claim interpretation was made without consideration of the disclosure of the specification. Furthermore, 2) the relationship between Groups I and II as a product and a process of use of the product alone does not establish unity of invention per se. Lastly, 3) whether serious burden exists is not the legal standard for requiring a restriction in a national stage application under 37 CFR 1.475 (a).
The requirement is still deemed proper and is therefore made FINAL.
Claims 6-11 and 13 are examined on the merits; Claims 1-5 have been withdrawn from consideration.
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.
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).
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.
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 volume and 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 Methods; the present 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 or 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, 7-10 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 claims 6, 7 and 13.
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.
Conclusion
No claims are allowed.
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/GINA C JUSTICE/Primary Examiner, Art Unit 1617