DETAILED ACTION
The present application is a domestic application filed 22 March 2024, which is a continuation of US Application No. 17/539,548 (now abandoned), filed 01 December 2021, which is a continuation of US Application No. 16/804,255 (now abandoned), filed 28 February 2020, which claims priority to US Provisional Application No. 62/812,338, filed 01 March 2019.
Claims 1-4 are pending in the current application and are examined on the merits herein.
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1-4 are rejected under 35 U.S.C. 101 because it is not a proper process claim. The claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
The recitation “which comprises restricting the administration of sotagliflozin…to patients with a Body Mass Index (BMI) ≥ 27 kg/m2” in claim 1 is not a clear active step.
The recitation “wherein the sotagliflozin is administered in an amount of 200 mg/day” in claim 3 does not clearly provide an active step. It could be interpreted to refer to patients identified as those already taking sotagliflozin, having type 1 diabetes, and taking insulin.
The claim could be amended to recite “comprising administering sotagliflozin to a subject having a Body Mass Index (BMI) ≥ 27 kg/m2”.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Present claims 1-4 does not recite an active step. Thus, it is unclear how this use is actually practiced. See MPEP 2173.05(q).
The recitation “which comprises restricting the administration of sotagliflozin…to patients with a Body Mass Index (BMI) ≥ 27 kg/m2” in claim 1 is not a clear active step.
It is not clear what step is involved in “restricting”, and the tense of the verb “the administration of” does not make it clear that this is an active step.
The recitation “wherein the sotagliflozin is administered in an amount of 200 mg/day” in claim 3 does not clearly provide an active step. It could be interpreted to refer to patients identified as those already taking sotagliflozin, having type 1 diabetes, and taking insulin.
The claim could be amended to recite “comprising administering sotagliflozin to a subject having a Body Mass Index (BMI) ≥ 27 kg/m2”.
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.
(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.
Claim(s) 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Buse et al. (Diabetes Care, first published online June 2018, vol. 41, pp. 1970-1980, cited in IDS submitted 22 May 2024).
Buse et al. teach it is difficult to achieve glycemic control for patients with type 1 diabetes (p.1971, first paragraph). Buse et al. teach performing a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in North America with 200 or 400 mg oral sotagliflozin once daily before the first meal of the day, combined with insulin in adults with inadequately controlled T1D (p.1971, second paragraph; and p.1972, first para). Buse et al. teach optimizing insulin therapy 6 weeks prior to randomization (p.1971, third paragraph). Optimizing insulin therapy was achieved by adjusting the basal and bolus doses to maintain fasting or pre-prandial blood glucose between 4.4 and 7.2 mmol/L (80 and 130 mg/dL) and 1- to 2-h postprandial glucose <10 mmol/L (<180 mg/dL), (p.1971, third paragraph). The BMI across all three treatment groups was 29.66 ± 5.387 kg/m2 (p.1974, Nonglycemic End Points). Sotagliflozin combined with optimized insulin therapy was associated with sustained HbA1c reduction, weight loss, lower insulin dose, fewer episodes of severe hypoglycemia, improved patient-reported outcomes, and more adjudicated diabetic ketoacidosis (DKA) relative to placebo (abstract). Buse et al. teach “among patients with a baseline HbA1c ≥ 7.0% after 6 weeks of insulin optimization, 15.7% of placebo-treated patients, 27.2% of patients receiving sotagliflozin 200 mg (p = 0.003 vs placebo), and 40.3% of patients receiving sotagliflozin 400 mg (p < 0.001) achieved an HbA1c < 7.0% at week 24. Within this subpopulation after 52 weeks, 18.4%, 27.7%, and 35.4% of patients receiving placebo, sotagliflozin 200 mg and sotagliflozin 400 mg, respectively, had an HbA1c < 7.0%” (p.1972, right column, Glycemic Control). Buse et al. teach insulin doses were not optimized prior to baseline in the inTandem3 trials.
The recitation “failed to achieve adequate glycemic control despite optimal insulin therapy” is not defined in the instant Specification. It is not clear what is encompassed by “adequate glycemic control”. Nor is it clear what is meant by “optimal insulin therapy”. For purposes of examination, the limitation is broadly and reasonably interpreted as including patients with type 1 diabetes, taking insulin, and having severe hypoglycemia.
Thus, the disclosure of Buse et al. anticipates claims 1-4 of the present application.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699
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