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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 6-7, 16, 22, 29, 30, 35-36, 41, 44, 47, and 48 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ben (US 20180140631 A1).
Regarding claims 1-2,and 29, Ben discloses a suspension containing a calcium source, a carbonate source, and a stabilizer/ pharmaceutically acceptable salt (Ben[0036]). These salts include bisphosphonate (stabilizer group) salts containing manganese, zinc, and magnesium (second divalent metal) (Ben[0105]) In the solution the size of the particles are between 20 to 100nm (Ben[0069]), with the molar ratio between the stabilizer and the calcium carbonate to be at 1:25 to 1:5 (Ben[0070]). Since the divalent metals are anions that are bonded to their specific cation groups, calcium with carbonate (CaCO3) and manganese with bisphosphate (Mn(H2PO4)2) , the molar ratio between calcium and the inorganic salt stabilizer can be used to calculate the molar ratio between the first and second divalent metals, because the second divalent metal has one metal atom in the stabilizer. With calcium designated as the first divalent metal and the salt carrying the second divalent metal, the molar ratio is the inverse if the stabilizer to calcium carbonate ratio. Therefore, the molar ratio of the first to second divalent metal is between 25:1 to 5:1. Further embodiments shows that the solution contains less than 30% of crystalline calcium carbonate, therefore indicating that 70% of the carbonate material is amorphous (Ben[0058]). The composition also contains an aqueous liquid carrier which acts as a solvent (Ben[0072])., The prior discloses that all solvents are considered pharmaceutically acceptable (Ben[0085,0087]).This disclosure fulfils the limitations set in the instant claims requiring the first divalent metal to be calcium, zinc, and manganese, a carbonate, a second divalent metal being magnesium, and a stabilizer consisting of bisphosphate, with a particle size between 5 to 500nm and with at least 70 wt.% of the carbonate is amorphous. Furthermore, the claims require the molar ratio of the stabilizer and first divalent metal between 1:100 and 25:100 and a molar ratio of the first and second divalent metal being between 10:0.05 (200:1) and 1:1.
Regarding claim 6, Ben discloses that other divalent metals can exist in the solution which will bond with the carbonate groups such as magnesium (Ben[0052]). With calcium as the first divalent metal and zinc being the second divalent metal, the disclosure fulfills the limitations set in the instant claim requiring a third divalent metal present in the solution.
Regarding claim 7, Ben discloses a composition containing calcium as the first divalent metal and the second divalent metal originating from a salt such as zinc bisphosphate (Ben[0105]). The prior art further shows an embodiment where that the composition contains less than 30 wt.% water (Ben[0062]). This disclosure fulfills the limitations set in the instant claim requiring the composition to contain between 30-1 wt.% of water with calcium as its first divalent metal with zinc as the second divalent metal.
Regarding claim 16, Ben discloses a composition comprising a plurality of particles with a stabilizing agent comprised of a bisphosphate salt (Ben[0105]) and calcium carbonate that contains less than 5 wt. % CCC (crystalline calcium carbonate carbonate) meaning that 95 wt.% of the carbonate is amorphous (Ben[0075]). This disclosure fulfills the limitations set in the instant claim requiring a stabilizer to be a bisphosphate and the carbonate to be at least a 95 wt.% amorphous.
Regarding claim 22, Ben discloses an embodiment of a solution containing an aqueous liquid carrier (Ben[0072]). The prior art further teaches that within a time period of 1 day the composition contains less than 5 wt. % CCC (crystalline calcium carbonate carbonate) (Ben[0074-0075]). This combined with the ACC (amorphous calcium carbonate) value in the suspension remaining stable within a 1-day timeframe, meaning that 95 wt.% of the carbonate is amorphous. The prior art meets the limitations set in the instant claim requiring solution to contain a liquid carrier with the carbonate species being 80% by weight amorphous over the course of a single day.
Regarding claim 30, Ben discloses a suspension containing a calcium source, a carbonate source, and a stabilizer or a pharmaceutically acceptable salt (Ben[0036]). These salts include bisphosphonate (stabilizer group) salts containing manganese, zinc, and magnesium (second divalent metal) (Ben[0105]) as well as polyphosphate salts that contain magnesium, manganese, and zinc (Ben[0063]). The polyphosphates used can be triphosphate/trisphosphates and hexametaphosphate (Ben[0063]). This disclosure meets the limitations set in the instant claim requiring the use of a polyphosphate, and said polyphosphate being triphosphate/trisphosphates or hexametaphosphate.
Regarding claims 35, Ben discloses a suspension containing a calcium source, a carbonate source, and a stabilizer or a pharmaceutically acceptable salt (Ben[0036]). These salts include polyphosphate salts that contain manganese and zinc (Ben[0063]).The prior art also discloses the use of a liquid carrier as a solvent(Ben[0072]), said solvent is considered a pharmaceutically acceptable liquid carrier (Ben[0085, 0087]). Therefore, this disclosure meets the limitations set in the instant claim requiring the composition to contain a pharmaceutically acceptable liquid carrier where a divalent metal is zinc or manganese.
Regarding claim 36, Ben discloses an embodiment of a solution containing a liquid carrier (Ben[0072]). The prior art further teaches that within a time period of 1 day the composition contains less than 5 wt. % CCC (crystalline calcium carbonate carbonate) (Ben[0075]). This combined with the ACC (amorphous calcium carbonate) value in the suspension remaining stable within a 1-day timeframe, meaning that 95 wt.% of the carbonate is amorphous. The prior art further shows an embodiment where that the composition contains less than 30 wt.% water (Ben[0062]). Therefore, the prior art meets the limitations set in the instant claim requiring the suspension to maintain the amorphous carbonate content at 80% for a day and the water content of the composition being between 1-30 wt.%.
Regarding claim 41, while Ben does not disclose the particles formed from the suspension as having a specific surface area, the prior art shares similarities to the claimed invention as it requires amorphous calcium carbonate and a stabilizer or a pharmaceutically acceptable salt (Ben[0016]). These salts include bisphosphonate (stabilizer group) salts containing manganese, zinc, and magnesium (second divalent metal) (Ben[0105]) . Further embodiments shows that the solution contains less than 30% of crystalline calcium carbonate, therefore indicating that 70% of the carbonate material is amorphous (Ben[0058]), with the molar ratio between the stabilizer and the calcium carbonate to be between 1:25 to 1:5 (Ben[0070]). The composition also contains an aqueous liquid carrier which is refers to as a pharmaceutically acceptable carrier (Ben[0072, 0087]). Due to the shared composition between the prior art and the claimed invention, the products would also share structural qualities such as the BET surface area to be between 20 to 200 m2/g.
Regarding claim 44, Ben discloses that the composition is grinded into a powder, forming aggregate particles with a size of 30 to 5µm (Ben[0068,0069]). Therefore, this disclosure meets the limitations set in the instant claim requiring a plurality of particles to form an aggregate with an average particle size between 0.1 to 200 µm.
Regarding claim 47, Ben discloses a suspension containing a calcium source, a carbonate source, and a stabilizer or a pharmaceutically acceptable salt (Ben[0036]). This results in the formation of calcium carbonate where calcium can be considered a first or second divalent metal. This disclosure fulfills the limitations set in the instant claim requiring the metal carbonate to be composed of the first or second divalent metals.
Regarding claim 48, the claim refers to the intended use of the composition without any chemical or structural limitations.
Claim Rejections - 35 USC § 103
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) 12-13, 15-16, 22, 25, 42, and 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ben (US 20180140631 A1).
Regarding claim 12, Ben discloses a suspension containing a calcium source, a carbonate source, and a stabilizer/ pharmaceutically acceptable salt (Ben[0036]). These salts include bisphosphonate (stabilizer group) salts containing manganese, zinc, and magnesium (second divalent metal) (Ben[0105]) In the solution the size of the particles are between 20 to 100nm, with the molar ratio between the stabilizer and the calcium carbonate to be at 1:25 to 1:5 (Ben[0070]). Since the divalent metals are anions that are bonded to their specific cation groups (calcium with carbonate, , the molar ratio between calcium and the inorganic salt stabilizer can be used to calculate the molar ratio between the first and second divalent metals. With calcium designated as the first divalent metal and the salt carrying the second divalent metal, the molar ratio is the inverse if the stabilizer to calcium carbonate ratio. Therefore, the molar ratio of the first to second divalent metal is between 25:1 to 5:1. The composition also contains an aqueous liquid carrier which acts as a solvent (Ben[0072]). The prior discloses that all solvents are considered pharmaceutically acceptable (Ben[0085,0087]).With the molar ratio between the first and the second divalent metal of the prior art being 25:1 to 5:1, it exceeds the 1% limitation required in the instant claim. This leads to a prima facie case. See MPEP 2144.05.
Regarding claim 13, Ben discloses an embodiment of a solution containing a liquid carrier (Ben[0072]). The prior art further teaches that within a time period of 1 day the composition contains less than 5 wt. % CCC (crystalline calcium carbonate carbonate) (Ben[0075]). With ACC and CCC making up the total amount of calcium carbonate the amount of ACC in the solution is 95 wt.% . Furthermore. The prior art notes that the ACC (amorphous calcium carbonate) value in the suspension remains stable within a 1-day timeframe (Ben[0074]). The prior art meets the limitations set in the instant claim requiring solution to contain a liquid carrier with the carbonate species being 80% by weight amorphous over the course of a single day.
Regarding claim 15, Ben discloses a suspension containing a calcium source, a carbonate source, and a stabilizer/ pharmaceutically acceptable salt (Ben[0036]). The prior art also discloses that other divalent metals can exist in the solution which will bond with the carbonate groups such as magnesium (Ben[0052]). In the solution the size of the particles are between 20 to 100nm (Ben[0069]). Further embodiments shows that the solution contains less than 30% of crystalline calcium carbonate, therefore indicating that 70% of the carbonate material is amorphous (Ben[0058]).
While Ben does not disclose the main carbonate divalent metal as Cu ,Co ,Ni, or Mg. One of ordinary skill in the art would be able to substitute one divalent metal (Ca) for another (Cu, Co, Ni, Mg) to product a carbonate material with 70% of it being amorphous.
Regarding claim 16, Ben discloses a composition comprising a plurality of particles with a stabilizing agent comprised of a bisphosphate salt (Ben[0105]) and calcium carbonate that contains less than 5 wt. % CCC (crystalline calcium carbonate carbonate) meaning that 95 wt.% of the carbonate is amorphous (Ben[0075]). This disclosure fulfills the limitations set in the instant claim requiring a stabilizer to be a bisphosphate and the carbonate to be at least a 95 wt.% amorphous.
Regarding claim 22, Ben discloses an embodiment of a solution containing an aqueous liquid carrier (Ben[0072]). The prior art further teaches that within a time period of 1 day the composition contains less than 5 wt. % CCC (crystalline calcium carbonate carbonate) (Ben[0074-0075]). This combined with the ACC (amorphous calcium carbonate) value in the suspension remaining stable within a 1-day timeframe, meaning that 95 wt.% of the carbonate is amorphous. The prior art meets the limitations set in the instant claim requiring solution to contain a liquid carrier with the carbonate species being 80% by weight amorphous over the course of a single day.
Regarding claim 25, Ben discloses a suspension containing a calcium source, a carbonate source, and a stabilizer or a pharmaceutically acceptable salt (Ben[0036]). These salts include polyphosphate salts that contain manganese and zinc (Ben[0063]).The prior art also discloses the use of a liquid carrier as a solvent(Ben[0072]), said solvent is considered a pharmaceutically acceptable liquid carrier (Ben[0085, 0087]). Therefore, this disclosure meets the limitations set in the instant claim requiring the composition to contain a pharmaceutically acceptable liquid carrier where a divalent metal is zinc or manganese.
Regarding claim 42, Ben teaches an example where the calcium solution and stabilizer is mixed with a carbonate solution to form ACC (Ben[0197]). One of ordinary skill in the art would have found it obvious, that due to the process of mixing in the example, the final product would have a homogenous distribution of the stabilizer.
Regarding claim 46, Ben discloses the carbonate to be calcium carbonate, the formula being CaCO3 indicating that the molar ratio of the divalent metal to carbonate species as 1:1. Since it overlaps with the claimed range. This leads to a prima facie case. See MPEP 2144.05.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNETTE H PHAN whose telephone number is (703)756-4520. The examiner can normally be reached M-F 8:30-6:30 EST.
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/ANNETTE PHAN/Examiner, Art Unit 1736
/ANTHONY J ZIMMER/Supervisory Patent Examiner, Art Unit 1736
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