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 .
Claim Rejections - 35 USC § 102/103
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
Claims 7, 12, 13, 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 2011 February 14; 17*6(; 779-783 (“Tatsuki” hereunder).
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.
Regarding claims 15, 22, 25 and 26, 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.
Claim Rejections - 35 USC § 103
Claims 8, 14, 16-19, 21, 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Tatsuki as applied to claims 7, 12, 13, 15, 20, 22 above, and further in view of Hattori (WO2020101016 A1, published on May 22, 2020).
Tatsuki fails to disclose the dosage of magnesium oxide administered to the pediatric subjects.
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.
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 8, 14, 18 and 24.
Claims 16, 17, 19, 23, 25 and 26 are met for the reasons discussed above.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Tatsuki as applied to claims 7, 12, 13, 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.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ministry of Health, Labour and Welfare (Overview of Survey Results. Summary of 2010 Infant Growth Survey, Table 1, cited in IDS) disclosing Japanese infants over 1 year old are over 7.5 kg or more.
Iwai et al. (JP 6355806 B1, published on July 11, 2018), teaching a laxative dose is preferably taken twice a day, morning and evening, while the night time after dinner and before bed time is particularly preferred. See p.5, 3rd full paragraph. The reference particularly teaches, the morning dose shows its effect in the evening, and the night dose shows its effect the next morning.
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/GINA C JUSTICE/Primary Examiner, Art Unit 1617