NON-FINAL REJECTION
Receipt is acknowledged of Applicants' Amendments and Remarks, filed May 14, 2026.
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The rejections and/or objections set forth below are either maintained or newly applied, and constitute the complete set presently applied to the instant claims.
STATUS OF THE CLAIMS
Claims 5-10 have been canceled.
Claims 1-4 and 11 have been amended and incorporate no new matter.
New claims 12-30 have been added.
Thus, claims 1-4 and 11-30 now represent all claims currently pending and under consideration.
INFORMATION DISCLOSURE STATEMENT
The information disclosure statement (IDS) submitted on Jul. 23, 2026 was filed after the mailing date of the non-final action on Dec. 23, 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
RESPONSE TO ARGUMENTS
The claim amendments filed May 14, 2026 overcome the rejections under 35 U.S.C. § 102 over Buck et al. and under 35 U.S.C. § 103 over Buck et al. in view of Liel et al., because the cited references do not disclose, teach, or suggest methods of administering the claimed dosage regimens to the claimed patient population(s). Therefore, these rejections are withdrawn. However, upon further consideration, a new ground of rejection is set forth below.
NEW OBJECTIONS/REJECTIONS
Specification
The disclosure is objected to because it contains embedded hyperlinks and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlinks and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code.
See MPEP § 608.01.
Claim Rejections - 35 USC § 112(b) - Indefiniteness
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 and 11-30 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Independent claims 1, 12, and 16 are drawn to methods for the treatment and/or prophylaxis of vitamin D insufficiency or deficiency in obese persons, comprising administering to an individual having a specified BMI a daily unit dose comprising vitamin D and 25(OH)D, wherein the patient population is further specified by those (i) who have a “normal lifestyle” with respect to UV light exposure and daily uptake of vitamin D, and those (ii) who have an “unfavorable lifestyle” with respect to UV light exposure and daily uptake of vitamin D.
The instant specification defines the term “normal lifestyle with respect to UV-light exposure” as follows:
“a qualified estimation by a skilled person of the average amount of hours per day a patient is exposed to UV-radiation from natural sources (sunlight) and/or from UV-radiation lamps during a given period of time such as e.g. the last several weeks or the last few months. The UV light exposure can also be derived based on measurements by a small wearable device such as the one described in an article in ScienceDaily on Jan. 9, 2018 (see: Northwestern University. “World's smallest wearable device warns of UV exposure, enables precision phototherapy.” ScienceDaily. ScienceDaily, 6 Dec. 2018.”
However, this is an ambiguous and non-limiting definition. Thus, the terms “normal lifestyle” and “unfavorable lifestyle” are relative terms which are not defined in clear-cut terms or in an objectively measurable way. The specification does not provide a standard for ascertaining the requisite degree, such that one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Citation of Additional Prior Art
Additional references made of record are considered pertinent to applicant's disclosure:
Drincic et al. J Clin Endocrinol Metab, 98(12):4845–4851 (2013) (cited on PTO-892).
CONCLUSION
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 10:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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/SARA E. TOWNSLEY/Examiner, Art Unit 1629
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