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 .
DETAILED ACTION
Response to Amendment
Acknowledgment is made of the receipt and entry of the amendment filed on 07/13/2026.
Election/Restrictions
During a telephone conversation with the attorney on the record, Akihiro Yamazaki (Reg # 46155), on 03/24/2026, a provisional election was made without traverse to prosecute the invention of Group II, directed to method of treating Hailey-Hailey disease, comprising administering a pharmaceutical composition comprising 5-methyl-2- (1-piperazinyl)benzenesulfonic acid to a subject in need thereof. Applicant affirmed this election on 07/13/2026. Claims 1 and 4 are withdrawn from further consideration according to 37 CFR 1.142(b), as being drawn to a non-elected invention.
Status of Claims
Claims 1-20 are pending.
Claims 1 and 4 are withdrawn.
Claims 2-3 and 5-20 are under examination in this office action.
Priority
This application 19/323,465 filed 09/09/2025 is a continuation of PCT/JP2025/023149 filed on 06/27/2025, which claims the benefit of priority to Japanese Application No. 2024-104617 filed on 06/28/2024.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of Japanese Application No. 2024-104617 filed on 01/07/2026 in Japanese, no English translation is included in the certified copy of foreign Application No 2024-104617 . Applicant’s right of foreign priority is not perfected due to lack of English translation thereof.
Information Disclosure Statement
The information disclosure statements filed on 04/14/2026 is in compliance with the provisions of 37 CFR1.97. Reference written in foreign language is considered to the degree of English abstract or patent family of foreign patent by the Examiner.
Claim Interpretation
According to PubChem database ( https://pubchem.ncbi.nlm.nih.gov/compound/6433076), 5-methyl-2-(1-piperazinyl)benzenesulfonic acid is also known as caldaret, caldaretum, MCC135, etc.
Instant claims are directed to a method of treating Hailey-Hailey disease, comprising administering a pharmaceutical composition comprising 5-methyl-2-(1-piperazinyl)benzenesulfonic acid to a subject in need thereof. Instant claims 5-7 and 15-17 recite intended treatment outcome such that at least one of dyskeratosis and acantholysis in Hailey-Hailey disease is suppressed which does not further limit the process step of administering 5-methyl-2-(1-piperazinyl)benzenesulfonic acid. Please note the wherein limitations of these claims are considered to simply express the intended result of process step of administering 5-methyl-2-(1-piperazinyl)benzenesulfonic acid , which does not necessarily contribute to patentable weight. See MPEP 2111.04: In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
Action Summary
Applicant's remarks filed 07/13/2026 have been fully considered. Any objection and rejection found in the previous Office Action and not repeated herein has been withdrawn in view of amendment and Applicant’s remarks .The text of those sections of Title 35 U.S. Code not included in this action can be found in a prior Office action.
Claims 2-3 and 5-20 remain rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement.
Claims 2-3 and 5-20 remain rejected under 35 U.S.C. 103 as being unpatentable over Yuki et al. (US20030114427A1 ), in view of Dhitavat et al ( British Journal of Dermatology, 2004, Vol. 50, pp 821-828) and Takahashi (US 20100130603 A1).
Claim Objection
Claims 3, 8, 13, 14 and 18 are objected to because of the following informalities:
Claims 3 and 13-14 recite “such that a dosage of the 5-methyl-2-(1- piperazinyl)benzenesulfonic acid is in a range of...” The phrase “such that” is vague and ambiguous as to whether the method step requires active administering a dosage of 5-methyl-2-(1- piperazinyl)benzenesulfonic acid within the claimed range. The claims should be rewritten without ambiguity.
Claims 8 and 18 recite wherein the subject in need thereof is a patient, which should be human patient.
Applicant argues the subject may be a test subject or participant, and may be a human (patient) or a non-human animal (affected animal). In that case, claim 3 and claim18 should recite human patient.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 2-3 and 5-20 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to use the full scope of the invention without undue experimentation.
To be enabling, the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). The determination that "undue experimentation" would have been needed to practice the claimed invention in full scope is not a single, simple factual determination.
As stated in the MPEP 2164.01(a), “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have need described. They are:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. Keeping that in mind, the Wands factors are relevant to the instant application for the following reasons:
The Breadth of The Claims/ Nature of The Invention
Claims 2-3 and 5-20 are directed to a method of treating Hailey-Hailey disease, comprising administering a pharmaceutical composition comprising 5-methyl-2-(1-piperazinyl)benzenesulfonic acid to a subject in need thereof. Instant claims 5-7 and 15-17 recite intended treatment outcome “ such that at least one of dyskeratosis and acantholysis in Hailey-Hailey disease is suppressed”. Instant claims 8 and 18 specifically recite the subject is a patient in need thereof. Instant Spec (page 3) defines the “treatment” as curing the disease, achieving remission of the disease, alleviation of the disease, or suppressing progression , etc.
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The State of the Prior Art and the Predictability or Lack Thereof in the Art
It is well known in the art that treatment of Hailey-Hailey disease (also known as benign familial pemphigus) is unpredictable and challenging. As disclosed in Clinical Practice Guidelines for familial benign chronic pemphigus by Japanese Dermatological Association(2023, Applicant’s IDS dated 09/09/2025): “familial benign chronic pemphigus (also known as Hailey-Hailey disease) is a hereditary skin disease that develops intractable erosive plaques in the axilla, groin, and other regions in adolescence or later. Although the responsible gene is known, the mechanism of onset of the disease has not yet been elucidated, and there is currently almost no effective treatment available”(See page 1).
Konstantinou (2023 ) teaches Hailey-Hailey disease HHD is a rare autosomal dominant genodermatoses caused by mutations in the ATP2C1 gene that encodes a calcium pump of the Golgi apparatus, with no curative treatment. Current therapeutic strategies aim to control disease flares, improve patients’ quality of life, and provide prolonged remissions. The management of HHD is based on anecdotal data from the off-label use of various topical, systemic and interventional treatments. Since HHD is a relapsing-remitting disease and lesions can present spontaneous remission, data from individual case reports and small case series with no control group are of limited value (Level of evidence 5). Randomized, prospective studies are lacking (See bridging page 4 and 5)
Porro (2024) reviews the pathogenesis, clinical picture, diagnostic methods and therapeutic options for Hailey-Hailey disease (HHD) (See whole article). Porro teaches HHD, is a rare genodermatosis, with an autosomal dominant inheritance pattern, characterized by compromised adhesion between epidermal keratinocytes... There is no cure and the treatment is challenging, including measures to control heat, sweat and friction, topical medications (corticosteroids, calcineurin inhibitors, antibiotics), systemic medications (antibiotics, corticosteroids, immunosuppressants, retinoids and immunobiological) and procedures such as botulinum toxin, laser and surgery. There is a lack of controlled clinical trials to support the choice of the best treatment(See Abstract, page 651). Porro concludes “There is no cure for this genodermatosis, which generally has a chronic evolution with periods of remission and exacerbation. The main goals of treatment are to relieve pain and pruritus, reduce the risk of secondary infection, and minimize factors that trigger exacerbations” (See conclusion, page).
More generally, the invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity (e.g., cancer prevention) is generally considered an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
The Amount of Direction Present and Presence or Absence of Working Examples
Instant specification does not provide sufficient efficacy data to fully support the claimed treatment outcome, e.g. suppression of dyskeratosis and acantholysis in patients suffering Hailey-Hailey disease. Instant specification discloses in-vitro study, wherein 5-methyl-2-(1- piperazinyl)benzenesulfonic acid monohydrate was evaluated by expression of differentiation marker molecules induced by ATP2C1 siRNA in an in-vitro HHD 3D cultured epidermal model (See Example 1, Fig. 1) and in-vitro epidermal intercellular adhesion disorder model (See Example 2, Fig. 2). Instant specification does not disclose any in-vivo assay wherein 5-methyl-2-(1- piperazinyl)benzenesulfonic acid monohydrate is administered, orally or parentally, to a “patient” (human subject or relevant animal model) exhibiting efficacy that dyskeratosis and/or acantholysis in Hailey-Hailey disease is suppressed. It’s well known that in-vitro data does not necessarily translate into efficacy in in-vivo study. Due to the lack of sufficient efficacy data and high unpredictability of treating HHD, an ordinary skilled in the art would not know if instant claimed 5-methyl-2-(1- piperazinyl)benzenesulfonic acid at a dosage range of 1-1000mg/day (e.g. 1mg/day) would be effective for suppressing dyskeratosis and/or acantholysis in a patient suffering Hailey-Hailey disease as claimed.
The level of one of ordinary skill in the art
The level of skill required to make and/or use the instant invention would likely require many years of professional experience conducting research in the art (e.g., medicine, pharmaceutical science, biology, biochemistry, etc.) as well as an advanced educational degree (e.g., M.D. and/or Ph.D.) commensurate in level with the advanced techniques involved in the preparation and/or use of the instant invention.
The quantity of experimentation needed
An unduly amount of experimentation would be required for one of ordinary skill in the art to use the claimed invention in full scope. In-vivo working examples would be needed to determine the efficacy of 5-methyl-2-(1- piperazinyl)benzenesulfonic acid monohydrate for treating HHD, e.g. therapeutically effective dose and administration variables for the intended treatment outcome in different subject. The therapeutically effective amount may vary depending on many factors, e.g. subjects being treated, the disease condition and intended treatment outcome. Therefore, it would be a great burden for one of ordinary skill in the art to carry out undue experimentation to use the claimed invention in full scope.
Conclusion
MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562,27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here with respect to the claimed method of treating Hailey-Hailey disease with 5-methyl-2-(1-piperazinyl)benzenesulfonic acid for the intended treatment outcome, in view of the analysis above pursuant to In re Wands. In other words, one skilled in the art could not practice the claimed invention in full scope without undue experimentation.
Response to Arguments
Applicant argues about activity of Compound A (MPBS) in instant disclosure: addition of Compound A (MPBS) suppressed the increased expression of differentiation markers (Example 1), MPBS has an improvement effect on bisphenol-induced epidermal intercellular adhesion disorder (Example 2), and the effect of MPBS on the transcriptome, that is, the expression changes of gene transcription products, in the epidermal intercellular adhesion disorder model (Example 3).
RESPONSE:
Applicant’s argument is fully considered, but NOT persuasive. The examiner does not dispute MPBS may exhibit certain effect on bisphenol- induced epidermal intercellular adhesion disorder as shown in Example 2. However, Hailey-Hailey disease is genetic disease related to SPCA1 expression in keratinocytes. SPCA1 is not explicitly disclosed in Example 1 and Example 3 as the gene changed by bisphenol and/or MPBS, and bisphenol A (BPA) model is not an established assay for evaluation of Hailey-Hailey disease.
Further, instant specification does not disclose any in-vivo assay that supports instant claimed efficacy and dosage regimen in an animal subject or human patient, wherein dyskeratosis and acantholysis is suppressed . Instant Example 2 discloses Compound A (i.e. MPBS) at 0.01 µmol/L, 0.1 µmol/L, or 1 µmol/L, which does not reasonably correlate with instant claimed dosage regimen for oral administration or parenteral injection in a range of 1-1000mg /day, 100-400mg/day, 1-3 times per day, etc.. It’s well known that in-vitro data does not necessarily translate into efficacy in in-vivo study. An ordinary skilled in the art would have to conduct undue experiment to validate instant claimed activity of MPBS administered orally or by parenteral injection in a subject (animal and/or human patient).
More importantly, instant Spec (page 3) defines a broad scope for “treatment”: curing the disease, achieving remission of the disease, alleviation of the disease, or suppressing progression , etc. As documented in the art, there is no cure for Hailey-Hailey disease and treatment is challenging with high recurrence rates, frequent secondary infections and lack of standard ATP2C1 knockout animal models. Due to the lack of in-vivo assay and high unpredictability, the full scope of instantly claimed treatment of Hailey-Hailey disease by MPBS is not fully supported by instant specification. An ordinary skilled in the art could not practice the claimed invention in full scope without undue experimentation.
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 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 non-obviousness.
Claims 2-3 and 5-20 remain rejected under 35 U.S.C. 103 as being unpatentable over Yuki et al. (US20030114427A1 ), in view of Dhitavat et al ( British Journal of Dermatology, 2004, Vol. 50, pp 821-828, Applicant’s IDS dated 09/09/2025, "Calcium pumps and keratinocytes lessons from Darier's disease and Hailey-Hailey disease") and Takahashi (US 20100130603 A1, Applicant’s IDS dated 01/20/2026).
Yuki teaches a method of treating and/or preventing nervous system disease/disorder comprising administering an active ingredient (e.g. piperazinyl benzenesulfonic acids) having an effect of improving calcium ion uptake of cardiac sarcoplasmic reticulum and/or an effect of inhibiting overaccumulation of intracellular calcium (See abstract, claim 1-37). Yuki explicitly teaches 5-methyl-2-(1-piperazinyl)benzenesulfonic acid monohydrate as the active ingredient improving calcium ion uptake of cardiac sarcoplasmic reticulum and/or inhibiting overaccumulation of intracellular calcium (See Reference Examples 1 and 2; claim 17).
Yuki teaches variety of assay with 5-methyl-2-(1-piperazinyl)benzenesulfonic acid monohydrate (See Examples 1-8; Figures 1-8). Yuki teaches 5-methyl-2-(1- piperazinyl)benzenesulfonic acid monohydrate may improve the reaction in sarcoplasmic reticulum calcium ion-ATPase activity induced by ischemia/reperfusion (See [0087]) and inhibit intracellular calcium ions overload (See [0094]).
Regarding the administration limitation recited in instant claims 3, 8-14 and 18-20, Yuki teaches active piperazinyl benzenesulfonic acid formulated in various dosage form, orally or parenterally administered to human in need thereof (See [0055]-[0058]). Yuki teaches dosage amount of active ingredient at about 0.01 mg-1,000 mg per day and administered in single to several doses per day(See [0058]) .
Yuki collectively teaches a method of treating disease/disorder associated with abnormal calcium metabolism with 5-methyl-2-(1-piperazinyl) benzenesulfonic acid by improving calcium ion uptake of cardiac sarcoplasmic reticulum and/or inhibiting overaccumulation of intracellular calcium.
Yuki is silent about Hailey-Hailey disease is associated with intracellular calcium overload. Dhitavat and incorporated reference teach defective Ca 2+ homeostasis is associated with Hailey-Hailey disease and Darier' s disease, wherein ATP2C1 have been identified as the causative genes for Hailey-Hailey disease and ATP2 C1 encodes a secretory pathway Ca2+ /Mn2+-ATPase (SPCA 1) found in the Golgi apparatus(See Summary, page 821, right column, second para; page 825, right column).
Regarding the intended treatment outcome as recited in instant claims 5-7 and 15-17, Dhitavat teaches acantholysis in Hailey-Hailey disease and Darier’s disease is associated with varying degrees of dyskeratosis and papillomatosis, loss of desmosomal adhesion triggers anoikis, a type of apoptosis characterized by cell detachment, in keratinocytes in Darier's disease and Hailey-Hailey disease wherein apoptosis may be secondary to changes in Ca2+ transport activity (See page 825, right column, last para; page 826, left column).
Takahashi teaches prophylactic and/or therapeutic treatment of dermatosis caused by excessively advanced keratinization resulting from abnormal calcium metabolism in epidermal keratinocytes, e.g. Hailey-Hailey disease, Darier's disease, etc. (See abstract, [0002], [0016], [0021], Examples 1-9, claims 1-4). Takahashi teaches treatment of Hailey-Hailey disease and Darier's disease by promoting gene expression of calcium pump in the endoplasmic reticulum, reducing intracellular calcium concentration, and thereby abnormal excessively advanced keratinization can be controlled (See [0021], [0044]-[0045]). Takahashi teaches acantholysis and dyskeratosis could be controlled in vivo assay (See Example 6).
It’s common practice in pharmaceutical industry to repurpose or explore different therapeutic use for drug/ active compound. It would have been prima facie obvious to one of the ordinary skilled in the art before the effective filing date of instantly claimed invention to further explore different therapeutic use of 5-methyl-2-(1- piperazinyl)benzenesulfonic acid for treating other disease/disorder associated with abnormal calcium metabolism, e.g. Hailey-Hailey disease as taught by Dhitavat and Takahashi, together with general knowledge of disease/disorder associated with calcium metabolism, and arrive at instantly claimed invention with reasonable expectation of success. At the time instant application was filed, it’s already known 5-methyl-2-(1-piperazinyl) benzenesulfonic acid could improve calcium ion uptake of cardiac sarcoplasmic reticulum and/or inhibit overaccumulation of intracellular calcium as taught by Yuki, It was also known Hailey-Hailey disease is associated with abnormal calcium metabolism and might be treated by active agent targeting at calcium metabolism as taught by Dhitavat and Takahashi. A skilled artisan would be motivated to further explore the use of 5-methyl-2-(1- piperazinyl)benzenesulfonic acid and reasonably expect 5-methyl-2-(1- piperazinyl)benzenesulfonic acid would ameliorate /suppress the symptoms of Hailey-Hailey disease (e.g. acantholysis and dyskeratosis) by improving calcium ion uptake of cardiac sarcoplasmic reticulum and/or inhibiting overaccumulation of intracellular calcium.
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art and exploration/optimization based on the general knowledge of disease/disorder associated with abnormal calcium metabolism. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant argues Takahashi describes treatments directed to keratinization, and the difference between Darier disease and Hailey-Hailey disease. In Darier disease, keratinization itself is a principal pathological feature, whereas in Hailey-Hailey disease keratinization occurs as a secondary manifestation of the disease process.
RESPONSE: The examiner does not dispute the difference between Darier disease and Hailey-Hailey disease. However, Darier disease and Hailey-Hailey are closely related genetic skin disease exhibiting acantholysis and dyskeratosis, and are researched/studied together as shown in the prior art, e.g. Dhitavat, Takahashi, etc. Takahashi teaches keratinization resulting from abnormal calcium metabolism in epidermal keratinocytes, e.g. Hailey-Hailey disease and Darier's disease, wherein acantholysis and dyskeratosis observed in Darier disease patient could be controlled in vivo assay (See Example 6 and 9). Although Yuki teaches the effect of 5-methyl-2-(1-piperazinyl) benzenesulfonic acid (MPBS) on the cardiac sarcoplasmic reticulum and is silent about ATP2 C1 in the Golgi bodies, the biological activity and mechanism of action is the property of 5-methyl-2-(1-piperazinyl) benzenesulfonic acid which does not necessarily contribute to the patentability of method of treatment. Dhitavat and incorporated reference teach defective Ca 2+ homeostasis is associated with Hailey-Hailey disease and Darier' s disease, wherein ATP2C1 have been identified as the causative genes for Hailey-Hailey disease and ATP2 C1 encodes a secretory pathway Ca2+ /Mn2+-ATPase (SPCA1). A skilled artisan would reasonably expect 5-methyl-2-(1- piperazinyl)benzenesulfonic acid would alleviate/ ameliorate the symptoms of acantholysis and dyskeratosis associated with intracellular calcium in Hailey-Hailey disease.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIYUAN MOU whose telephone number is (571)270-1791. The examiner can normally be reached Mon-Fri 9:00-5:30.
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/LIYUAN MOU/ Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628
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