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 .
Detailed Action
Status of Application
1. Applicants’ arguments/remarks filed 24 July 2026 are acknowledged. Claims 1-3 and 5-10 are currently pending. Claim 4 is cancelled. No amendments have been made. Claims 1-3 and 5-10 are examined on the merits within.
Maintained Rejections
Claim Rejections – 35 U.S.C. 103
2. 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.
3. Claim(s) 1-3 and 5-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hansen (WO2006/072252) in view of Rosendahl et al. (European Journal of Physiology, 2016).
Hansen teaches compositions for treating hypocalcemia in cows. See page 1. The composition comprises at least 30 grams of calcium and other minerals, vitamins, additives, carriers and excipients. See page 12. Hansen teaches that a bullet comprising 57.9 % CaCl2 x 6H2O, 23.2% CaSO4 x ½ H2O, 14.4% water, and 4.5% glyceryl PEG ricinolate (coating material) is known. See page 4. The composition comprises a calcium source in a water soluble, dispersible or disintegrable casing composed of cellulose or starch material (i.e., binder excipient). See page 8. The composition comprises at least 30 g of calcium per casing or capsule. See page 12.
Hansen does not teach menthol.
Rosendahl et al. teach menthol or thymol stimulated the I in Na+ or NH4 + containing solutions in a dose-dependent manner and modulated transepithelial Ca2+ fluxes. See abstract. The two lower concentrations of menthol (10 and 100 μmol·l−1) significantly enhanced the net absorption of Ca2+ by the ruminal epithelium, via mechanisms that probably involve both a direct action on TRP channels and secondary effects on barrier-forming proteins of the paracellular pathway. See page 1349.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to add menthol to the formulation of Hansen to improve calcium absorption. One would have been motivated, with a reasonable expectation of success, to provide a more effective formulation in the treatment of hypocalcemia in ruminants. It would have been well within the purview of the skilled artisan to modify the amounts of each ingredient within known effective amounts and ratios to achieve the desired consistency of product and improvement of calcium absorption.
Response to Arguments
Applicant's arguments filed 24 July 2026 have been fully considered but they are not persuasive.
4. Applicants argued, “The simultaneous effect of both an increased calcium flux and a decreased paracellular flux was found to be more pronounced at higher calcium concentrations which is unexpected and unpredictable. One would not have any reason to combine Hansens’ suggestion of higher calcium concentrations with Rosendahl’s reporting of the effect of menthol at low/normal calcium concentrations.”
In response to applicants’ arguments, Rosendahl teaches that two lower concentrations of menthol (10 and 100 μmol·l−1) significantly enhanced the net absorption of Ca2+ by the ruminal epithelium, via mechanisms that probably involve both a direct action on TRP channels and secondary effects on barrier-forming proteins of the paracellular pathway. See page 1349. Thus Rosendahl provides motivation to add menthol to improve calcium absorption. This coincides with the data found in Table 2. Although Examples A and 2 show a statistically significant increase, Example 1 does not. However the concentration of Ca in Example 1 is between the values of A and 2. Thus not all concentrations result in a statistically significant increase. The same is observed in Table 4 wherein only Example 4 is statistically significant. However, all concentrations tested fall within the claimed amount of at least 5% calcium. It is also noted that Examples A, 1, 2, B, 3, and 4 comprise various other components that are not claimed and thus a side by side analysis cannot be conducted and unexpected superiority cannot be determined.
Thus this rejection is maintained.
Conclusion
5. 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.
Correspondence
6. No claims are allowed at this time.
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Wax can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
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