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 .
All claim rejections made under 35 U.S.C. 102 or 103 as indicated in the Office action dated January 14, 2026 have been withdrawn in view of the amendment made to claim 7, which requires that the pharmaceutical composition is in the form of tablets or fine granules, and when suspended in water, have specific D50 and D90.
New rejections have been made to address the amended claims.
Claim Rejections - 35 USC § 103
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.
Claims 7, 12-15, 20-22 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Tatsuki et al. (“Serum magnesium concentration in children with functional constipation treated with magnesium oxide”, World J Gastroenterol, vol. 17, no. 6, February 14, 2011, 779-783), (“Tatsuki” hereunder) in view of Hattori (WO2020101016 A1, published on May 22, 2020) in view of Hattori (WO 2020101016 A1, published on May 22, 2020).
Tatsuki discloses a study in which 120 children aged 1-14 with constipation were treated with oral magnesium oxide once daily or in split doses for at least one month. See p. 780, Materials and Methods, Patients. Median dose was 600 (500-800) mg/d and 33 (25-45) mg/kg per day. The study reports improvement in bowel habits in all patients, and the median serum magnesium concentration was below the maximum value of the normal range. See p. 6, Results.
Although Tatsuki does not disclose the body weight of the participating children or pediatric subjects who would be treated for constipation according to the teachings, the children in the study were in the overlapping age group (1-14) of the present invention, which indicates that children having a body weight 7.5 kg or more were involved in the study. Thus, claim 7 is anticipated by or unpatentable over Tatsuki.
Tatsuki fails to disclose the specific dosage form of magnesium oxide administered to the pediatric subjects as described in the present claim 7.
Hattori teaches a laxative orodispersible tablet which can be also used as a tube formulation suitable for children and patients with dysphagia. See US Equivalent, US 12053549 B2, see col. 1, lines 48 – 58. Magnesium oxide is the main active. The reference teaches that the rapid disintegrable formulation reduces burden for patients and also enables the practitioner to make an aqueous suspension without having crush the tablet, which improves stability and efficacy of the drug. The reference teaches that tablet comprises 50-250 mg of magnesium oxide per tablet, suitable for children. See col. 3, lines 11 – 44. The reference specifically disclose that the laxative tablet has the particle size by volume of 50 % (D50) of particles when the tablet is suspended in water is 70 microns or less (e.g., 61.3 microns) as determined by laser diffractometry, and the particle size by volume of 90% (D()) of the particles is 130 microns or less (e.g., 125.7 microns). See abstract; Table 7.
Given the teachings of magnesium oxide as a pediatric laxative in Tatsuki, one of ordinary skill in the art before the effective filing date of the present application would have been obviously motivated to look to prior art such as Hattori for suitable formulations of magnesium oxide that can be used for pediatric patients with chronic constipation. Since the latter teaches an orodispersible tablet that is also suitable to form an aqueous suspension for tube administration, the skilled artisan would have been motivated to use such dosage form with a reasonable expectation of successfully and safely administering magnesium oxide to pediatric patients who have challenges in swallowing medicines. See the present claims 7, 14 and 24.
Regarding claims 15 and 22, Tatsuki reports that the daily magnesium treatment continued for at least one month.
Regarding claim 12, Tatsuki teaches that the pediatric subjects suffered from functional constipation, which is a form of chronic constipation.
Regarding claim 13 and 20, the mean daily dose of magnesium oxide in prior art is 33 mg/kg, which is well within the presently claimed range of 30.11 to 35.83 mg/kg.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Tatsuki and Hattori as applied to claims 7, 12-15, 20-22 above, and further in view of Adams (US 20040241134 A1, published on December 2, 2004).
Tatsuki does not specifically disclose the dosing time of the magnesium administration.
Adams teach a method of treating chronic constipation, the method comprising administering a laxative comprising a polycarbophil and flax seed powder to a patient in need thereof. See abstract. The reference teaches that the composition can be administered after each meal and before bedtime, resulting in colon cleansing after a period of less than 72 hours, and then reducing the dosage to twice a day, after breakfast and after dinner, so as to have regular bowel movements. See Preferred Method.
Regarding claims 9 and 10, Since Tatsuki teaches and suggests administering magnesium oxide in split dose, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to look to prior art such as Adams which teaches specific dosing time of administering laxative. Since both references are directed to oral treatment for functional constipation, the skilled artisan would have been obviously motivated to combine the teachings of the references with a reasonable expectation of successfully inducing regular bowel movements in pediatric patients.
Regarding claim 11, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify the Tatsuki teachings and administer an additional dose of magnesium oxide before bedtime to initiate the therapy or induce colon cleansing as motivated by Adams. Since the latter suggests that laxative administration induces dose dependent results, adjusting the dose according to the patient’s need and targeted results would have been prima facie obvious.
Response to Arguments
Applicant’s arguments with respect to claims 7, 9-15 and 20-22 have been considered but are moot in view of the new ground of rejection as indicated above.
Regarding the Adams reference, applicant argues that the reference is directed to different types of laxatives other than magnesium oxide, however, the examiner respectfully points out that the method steps in claims 9-11 only involve the dosing time of the magnesium oxide tablet to obtain laxative effects. In view of the teachings of Adams that laxatives are taken twice a day to have regular bowel movements, taking the magnesium oxide tablet twice a day for the same reason would have been prima facie obvious.
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
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