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 .
Election/Restrictions
Applicant’s election without traverse of group I in the reply filed on 12/29/25 is acknowledged.
Claims 10 and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/29/25.
Claim Rejections - 35 USC § 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 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.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sekharam (US
2022/0160628A1) in view of Preisig et al. (US 10,391,061B2) and Dixit et al. (US 2018/0169008A1) and in
further view of Jeong et al. (Mater. Trans. Vol. 50, No. 2 (2009) pp 409-414).
Sekharam (US 2022/0160628A1) discloses a process for manufacturing semi-soft solid dosage forms/soft chew comprising a.) blending an active ingredient with one or more excipients and/or wetting agents (p1, [0018-0019]; p2, [0034],[0055]; p4, [0063]).
The active ingredient comprises health supplements, therapeutic agents, etc. (p2, [0025],[0040],[0046-0047]).
The excipients comprise calcium carbonate, dicalcium phosphate, etc. (p1-2, [0024]) that encompass the calcium carbonate and/or dicalcium phosphate edible grade inorganic salt of the instant claims.
The process comprises b.) adding a solid fat melted to at least 40°C along with one or more releasing agents (p1, [0020]; p2, [0035]).
The solid fat(s) comprise stearic acid, beef tallow, pork fat, magnesium stearate, etc. (p2, [0028],[0043]) that encompass the long chain fatty acid with 13-21 carbon atoms, such as stearic acid, and magnesium stearate of the instant claims and the solid fat, such as beef tallow and pork fat of the instant claims.
The releasing agent comprises lecithin, gum arabic, etc. (p2, [0027]).
Optional ingredients can be used in the process, for example, flavorings, palatants, sweeteners, etc. (p2, [0029]).
The process comprises (c) blending the ingredients to form a dough at a temperature below 35°C, not excluding room temperature and d.) shaping the dough to a desired shape, weight, size, and hardness (p1, [0021-0022]; p2, [0036-0037]).
The dough may be passed through any customary shaping device, including an extruder to form chews of right shape and uniform weights. The chews are cured for 24 hours and packaged (p4, [0066]).
Passing of the dough through an extruder provides for a chew of desired shape and weight that
encompasses extruding the shapeable dough to make the chew of desired shape and weight of the instant claims.
Sekharam does not disclose the joint-health-ingredient of the instant claims.
Preisig et al. (US 10,391,061B2) discloses a delayed release pharmaceutical comprising a calcium carbonate and at least one active agent (column 3, lines 16-22; column 4, lines 18-20).
The calcium carbonate is loaded with at least one active agent by mixing them together in a solvent to form a solution (column 9, lines 41-57).
The calcium carbonate can be embedded within a matrix of a material for intestinal targeting and further comprise compounds, such as chondroitin sulfate (column 6, lines 32-42; column 7, lines 55-56).
The calcium carbonate particles embedded in the matrix may be further coated with fatty acid, such as stearic acid to impart hydrophobicity to the surface and allow for a higher load of hydrophobic drug to be loaded (column 8, lines 37-59). The coating of the particles may be conducted via spray coating or melt extrusion (column 9, lines 58-61).
Dixit et al. (US 2018/0169008A1) discloses soft chews can increase patient acceptance of a medication as they are used as alternatives to tablets and capsules that must be swallowed whole (p1, [0003]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the health supplement of the drug delivery soft chews of Sekharam with the chondroitin sulfate health supplement of Preisig et al. as Preisig et al. teaches of drug delivery of chondroitin sulfate from stearic acid coated calcium carbonate particles and the soft chews of Sekharam predictably provide for ease of delivery of chondroitin sulfate health supplement via chewing as opposed to swallowing a whole tablet or capsule.
Sekharam does not explicitly disclose melting the solid fat(s) with the one or more releasing agents at a temperature of not less than 70°C and using a direct melting spray method.
Jeong et al. (Mater. Trans. Vol. 50, No. 2 (2009) pp 409-414) discloses calcium carbonate particles treated with stearic acid (SA) using a dry process coating system (abstract).
Molten SA was adsorbed onto the surface of calcium carbonate particles using the dry process coating system of a direct melting spray method wherein the temperatures of the melting, transfer and spray parts of SA was maintained at 100 ± 10°C to allow melting and spraying (p410, 2.2 Adsorption experiment).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the direct melting spray method of Jeong et al. at 100 ± 10°C to allow melting and spraying of the melted solid fat/releasing agent (e.g. stearic acid, beef tallow, pork fat and/or magnesium stearate) into the calcium carbonate particle mixture of Sekharam as Preisig et al. teaches of spray coating calcium carbonate particles of the with stearic acid for the advantage of providing a higher load of hydrophobic drug to be loaded.
Sekharam does not explicitly disclose the ratio of joint-health ingredient to edible grade inorganic salt of the instant claim 7 or the ratio of fatty acid with 13 to 21 carbon atoms to solid fat of the instant claim 8.
Sekharam further discloses that the calcium carbonate or dicalcium phosphate may comprise 5% to 75%, 10%-60%, etc. of the edible chew (p2, [0024]).
The solid fat comprises from about 1 to about 15% (w/w) of the soft chew (p2, [0028]).
The active agent comprises from about 0.1% to about 25% w/w of the soft chew (p3, [0052]).
Furthermore, it is obvious to vary and/or optimize the amount of joint-health, edible grade
inorganic salt, fatty acid with 13-21 carbon atoms and/or solid fat provided in the composition,
according to the guidance provided by Sekharam, to provide a composition having the desired properties such as the desired ratio of joint-health ingredient to edible grade inorganic salt and the ratio of fatty acid with 13-21 carbon atoms to solid fat to provide the correct drug loading, texture, taste, flavor and hardness of the soft chews. It is noted that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
No claims are allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA JEAN PERREIRA whose telephone number is (571)272-1354. The examiner can normally be reached M9-3, T9-3, W9-3, Th9-2, F9-2.
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/MELISSA J PERREIRA/Examiner, Art Unit 1618