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 .
Current Status of 18/728,545
This Office Action is responsive to the amended claims of 10/22/2025.
Claims 1, 42-54 are examined on the merits.
Priority
This application is a national stage entry of PCT/US2023/010800 and claims foreign priority to IN202241002534.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The effective filing date is 1/17/2022.
Response to Arguments
Applicants’ claim amendments and Remarks of 10/22/2025 are acknowledged and have been considered.
The claim objection is withdrawn.
In regard to the 103 rejection for claims 1 and 42-54, Applicants amended claim 41 into claim 1. However, applicants have not addressed the underlying rationale (e.g. Kerkhoven logic) underpinning the rejection using KOSBAB in view of NIH and LOFSSON. Examiner will update and maintain the basis for this rejection.
In regard to the 103 rejection for claims 1 and 41, this rejection is maintained. Comprising is open ended claim language. The whole composition of KOSBAB was not combined in this obviousness rejection. An artisan would have been motivated by the teachings in GOSSELIN, WALLE, and ZHANG to combine vitamin D3, niacinamide, and lipoic acid (all known to have use in treating/preventing prediabetes or diabetes in a subject) in order to make a nutraceutical composition specifically for this same purpose. This would be a new nutraceutical composition comprising of only vitamin D3, niacinamide, and lipoic acid as active ingredients. It is prima facie obvious to combine one treatment/prevention for prediabetes or diabetes with another in order to form a composition to be used for the very same purpose. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06(I).
Response to Amendment
Claim Rejections - 35 USC § 103 – Maintained
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 nonobviousness.
Claim(s) 1 and 42-54 are rejected under 35 U.S.C. 103 as being unpatentable over KOSBAB (WO 98/33494) in view of NIH (“Definition of Nutraceutical”, NCL Dictionary of Cancer Term, NIH, February 28, 2003), GOSSELIN (Gosselin et al., “Metabolic effects of α-lipoic acid supplementation in pre-diabetics: a randomized, placebo-controlled pilot study”, Food Funct., September 1, 2019), WALLE (sWalle, “Niacinamide: Benefits, Uses and Side Effects”, Healthline, November 16, 2018), and ZHANG (Zhang et al., “Effects of Vitamin D supplementation on Prevention of Type 2 Diabetes in Patients with Prediabetes: A Systematic Review and Meta-analysis”, Diabetes Care, June 11, 2020).
Note, the phrase “for treating or preventing the complications of pre-diabetes or diabetes” is interpreted as intended use. Nothing precludes the use as claimed.
KOSBAB teaches compositions for use in the treatment and prevention of the complications of pre-diabetes and diabetes (page 2, lines 14-17) and for use in complication of pre-diabetes and diabetes include diabetic microangiopathy (see page 2 lines 20-25). This helps teach claim 1.
KOSBAB teaches in Table 3: Preferred Dosage Ranges for Exemplary Formula Components of this Invention which comprises 1-10,000 IU Vitamin D3 (page 48 line 22), 1 -500 mg Niacinamide (page 48 line 5), and 5 - 1,000 mg Lipoic acid (page 47 line 20). This helps teach claim 1.
KOSBAB only teaches Lipoic acid (also referred to as alpha-lipoic acid) and does not specify R or S enantiomer. Examiner understands that lipoic acid is a blend of naturally occurring R and S lipoic acid. This teaches claim 45.
NIH teaches that a nutraceutical is a food or dietary supplement that is believed to produce health benefits (page 1). This helps teach claim 1.
KOSBAB teaches that the compositions of this invention can be provided in a variety of nutrient and dosage forms including pills, tablets, capsules, lozenges, powders, solutions, suspensions, injection dosage forms (page 20). This teaches claim 46 and helps teach claim 52.
KOSBAB teaches that Active ingredients of the formulas of this invention can be combined with excipients, fillers, buffering agents (page 20). This teaches claims 47-48.
KOSBAB also teaches a method for treating and/or preventing symptoms, conditions or disorders associated with diabetic (page 3, page 19 lines 20-30, and claim 28). This helps teach claim 49.
KOSBAB teaches that the amounts listed in Table 3 are the “a daily oral dosage form”, which is a once a day dose (page 37). This teaches claim 53 and 51.
LOFTSSON teaches that dosage regimens are based on average pharmacokinetic parameters (page 120). LOFTSSON also teaches that these parameters may vary with patients’ gender, age, weight, and disease state (page 120). Furthermore, dosage adjustment is known (examples 5.1-5.4 on pages 120-124).
While KOSBAB teaches a composition for use in the treatment and prevention of the complications of pre-diabetes and diabetes (page 2, lines 14-17) containing 1-10,000 IU Vitamin D3 (page 48 line 22), 1 -500 mg Niacinamide (page 48 line 5), and 5 - 1,000 mg Lipoic acid (page 47 line 20), KOSBAB does not anticipate a singular example of the instant’s composition.
KOSBAB does not explicitly called its oral composition a “nutraceutical” but KOSBAB does teach that it’s a dietary supplement that is believed to produce health benefits (in line with NIH’s definition). This helps teach claim 1.
GOSSELIN teaches that alpha-lipoic acid supplementation may be a useful strategy to improve insulin sensitivity in pre-diabetic subjects but is not effective in modulating serum lipids (abstract).
WALLE teaches that niacinamide protects and preserves the beta cells, thereby preventing or delaying the onset of type 1 diabetes in at-risk individuals (page 3).
ZHANG teaches that in persons with prediabetes, vitamin D supplementation (which comprised vitamin D3) reduces the risk of T2DM and increases the reversion rate of to normoglycemia (conclusions and table 1).
While KOSBAB in view of NIH teaches claim 1 above, KOSBAB does not teach that the only active ingredients are vitamin D3, niacinamide, and lipoic acid.
An artisan would have been motivated by the teachings in GOSSELIN, WALLE, and ZHANG to combine vitamin D3, niacinamide, and lipoic acid (all known to have use in treating/preventing prediabetes or diabetes in a subject) in order to make a nutraceutical composition specifically for this same purpose. It is prima facie obvious to combine one treatment/prevention for prediabetes or diabetes with another in order to form a composition to be used for the very same purpose. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06(I). This help teach claim 1.
The artisan would have been motivated to optimize the amount of vitamin D3, Niacinamide, and Lipoic acid. One would be motivated to adjust the amount because this is something that is routinely practiced in the pharmaceutical arts (KOSBAB page 37 lines 20-30). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See MPEP 2144.05(II)A. Thus, the artisan would be motivated and expected to optimize the dosage of the vitamin D3, Niacinamide, and Lipoic acid. This teaches claims 1, and 42-44.
KOSBAB teaches a method for treating and/or preventing symptoms, conditions or disorders associated with diabetic (page 3, page 19 lines 20-30, and claim 28). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. See MPEP 2112 (II). The artisan would not have needed to recognized that administering KOSBAB’s composition would have also had an average decrease of fasting blood glucose level of 20% or more …after 12 weeks of treatment. This teaches claim 49.
The artisan would have been motivated to give the composition containing vitamin D3, Niacinamide, and Lipoic acid to a subpopulation of claim 50. It is obvious to administer the “nutraceutical” to any person for general health benefits, including that sub-population, because nothing precludes them from the “nutraceutical”. This teaches claim 50.
Furthermore, the artisan would have been motivated to optimize the times of the dosages (i.e. scheduling). It would be obvious to optimize the dosing regimen to maintain a therapeutic window and adjust for the impacts of disease state, age, weight, etc. (LOFTSSON pages 120-124). One would be motivated to adjust the regimen to maintain the therapeutic window, and would have a reasonable expectation for success in doing so, because this is something that is routinely practiced in the pharmaceutical arts. See MPEP 2144.05(II)A. Nothing in the specification or record appears to indicate the dosing regimen claimed is critical. Thus, the artisan would be motivated and expected to optimize the scheduling of the nutraceutical. This teaches claim 54.
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.
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/G.A.H./ Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625