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 .
Claims and Previous Objections/Rejections Status
Claims 1-9 and 12 are pending in the application. Claims 10 and 11 are cancelled and claim 12 is newly added in the amendment filed 7/31/26.
Any objections and/or rejections from previous office actions that have not been reiterated in this office action are obviated.
New Grounds of Rejection
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 Biology Stack Exchange: Melting Points of Animal Fats and Body
Temperature Oct 24, 2022 (lipids - Melting Points of Animal Fats and Body Temperature - Biology Stack Exchange, https://www.bing.com/ck/a?!&&p=7082ba56717a35ef400528d3300bec249f96c5d99e30711a44458a34f77132baJmltdHM9MTc4NzAxMTIwMA&ptn=3&ver=2&hsh=4&fclid=0f5f2453-e6df-6769-132e-33eae7cd6682&psq=tallow+melting+points+chart&u=a1aHR0cHM6Ly9iaW9sb2d5LnN0YWNrZXhjaGFuZ2UuY29tL3F1ZXN0aW9ucy8xMDczODgvbWVsdGluZy1wb2ludHMtb2YtYW5pbWFsLWZhdHMtYW5kLWJvZHktdGVtcGVyYXR1cmU) and in further view of Preisig et al. (US 10,391,061B2), Dixit et al. (US 2018/0169008A1) and Han et al. (Powder Technol. 356 (2019) 414-422).
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 or combinations thereof that are 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. or combinations thereof (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 explicitly disclose the melting temperature to form Mix-2 is not less than 70°C.
Biology Stack Exchange: Melting Points of Animal Fats and Body Temperature Oct 24, 2022 discloses that lard melts at 30-48°C (86-118.4°F) and beef tallow melts around 45-50°C (113-122°F).
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 appropriate melting temperature to melt the type of solid fat (e.g. pork fat and beef tallow) used for the process for manufacturing semi-soft solid dosage forms/soft chew of Sekharam who teaches that the melting temperature is at least 40°C and the melting temperatures of pork fat and beef tallow comprise 86-118.4°F and 113-122°F, respectively as taught by Biology Stack Exchange.
Sekharam does not disclose the joint-health-ingredient of the instant claims or spray mixing Mix-1 and Mix-2.
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]).
Han et al. (Powder Technol. 356 (2019) 414-422) discloses that the use of calcium carbonate particles in biomedicine requires good compatibility between nano-CaCO3 and organics. Surface modification with stearate allow for effective mixing with organic substrates and hydrophobicity (abstract; p414, 1.Introduction; Table 2).
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.
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 spray method of Preisig et al. prepare stearate modified calcium
carbonate particles for the advantage of providing effective mixing with of calcium carbonate with
organic substrates and imparting hydrophobicity and compatibility with organic substrates.
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).
Response to Arguments
Applicant asserts that although Sekharam does not exclude the use of a temperature of at least 70°C, it certainly does not teach this elevated temperature. Nor would there be any reason to modify the teaching of Sekharam to use an elevated temperature. Sekharam specifically notes that the production of chews at a reduced dough temperature is an advantage of the method.
The reference of Sekharam teaches that the reduced temperature advantage is for the blending
step that follows the higher temperature melted fat addition step wherein the reduced temperature blending step results in a mixture that is formed into a dough at a temperature below 35°C.
The reference of Sekharam was used to teach of the step of adding the solid fat at a melting
temperature of at least 40°C wherein the solid fats comprise pork fat and beef tallow as well as that stated above.
The reference of Biology Stack Exchange was used to teach that the melting temperatures of pork fat and beef tallow comprise 86-118.4°F and 113-122°F, respectively.
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 appropriate melting temperature to melt the type of solid fat (e.g. pork fat and beef tallow) used for the process for manufacturing semi-soft solid dosage forms/soft chew of Sekharam who teaches that the melting temperature is at least 40°C and the melting temperatures of pork fat and beef tallow comprise 86-118.4°F and 113-122°F, respectively as taught by Biology Stack Exchange.
Therefore, the method of Sekharam does not need to be modified as the reference clearly states that the solid fat(s) mixture is necessarily melted at the melting temperature of the solid fat(s) mixture.
The Applicant’s assertions with regards to Jeong et al. are moot as the reference is not used in the instant rejection.
The reference of Han et al. was used to teach that the use of calcium carbonate particles in biomedicine requires good compatibility between nano-CaCO3 and organics. Surface modification with stearate allow for effective mixing with organic substrates and hydrophobicity.
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to prepare stearate modified calcium carbonate particles for the advantage of
providing effective mixing of calcium carbonate with organic substrates and imparting hydrophobicity.
Applicant asserts that the reference of Preisig et al. does not teach or suggest the use of soft chews and in fact the soft chew would be unsuitable for delivery an active through the stomach and small intestines, and make it all the way to the colon. As for the use of stearic acid by Preisig et al. in their system, the stearic acid can be used to impart hydrophobicity to the surface of calcium carbonate and allow for a higher payload of hydrophobic drug to be loaded. Unlike the Applicant’s method wherein an active agent is blended with an inorganic salt (such as calcium carbonate), in the Preisig method, the stearic acid is used to functionalize the calcium carbonate, prior to loading a hydrophobic active agent. Nothing in Preisig would suggest to the skilled artisan a method wherein stearic acid is melted with a solid fat, and then mixed with particles of calcium carbonate to which an active agent has already been added.
The reference of Sekharam teaches of blending an active ingredient with one or more
calcium carbonate to form a mixture and melting a solid fat(s) mixture (e.g. stearic acid, beef tallow, pork fat, etc.) to at least 40°C along with one or more releasing agents.
Therefore, the stearic acid and solid fat(s) are added together in combination as a melted mixture to the calcium carbonate mixture like that of the Applicant’s method.
The reference of Preisig was not used to teach of soft chews or coating calcium carbonate prior to addition of a melted solid fat mixture but was used to teach that calcium carbonate coated with stearic acid to impart hydrophobicity to the surface and allow for a higher load of hydrophobic drug to be loaded.
The reference of Han et al. teaches that the use of calcium carbonate particles in biomedicine requires good compatibility between nano-CaCO3 and organics. Surface modification with stearate allow
for effective mixing with organic substrates and hydrophobicity.
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the calcium carbonate with a stearic acid/fat melted mixture for the advantage of providing compatibility with organic substrates and imparting hydrophobicity.
Applicant asserts that with regards to the ratios of the instant claim 7 and of claim 8, for optimization to be “routine,” a particular component must first be recognized as a result-effective variable. Additionally, optimization is obvious only when it is reasonable expected that an improvement will arise in that range.
The reference of Sekharam further discloses that the calcium carbonate or dicalcium phosphate may comprise 5% to 75%, 10%-60%, etc. of the edible chew.
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]).
Therefore, 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 result-effective variable of 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
Claim 12 is allowed.
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/MELISSA J PERREIRA/ Examiner, Art Unit 1618
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