DETAILED ACTION
Pending Claims
Claims 1-19 are pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 § 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.
Claims 1-3, 5-7, and 9-17 are rejected under 35 U.S.C. 103 as being unpatentable over Chaput et al. (US 2003/0199615 A1).
Regarding claims 1-3, 5-7, 11, 13, and 14, Chaput et al. disclose a (1) curable calcium phosphate dental cement (paragraphs 0040-0045 & 0154-0158; see also paragraphs 0212-0218) comprising:
a first material as powder or nonaqueous paste (paragraphs 0119-0129 & 0213: mineral phase); and
a second material as liquid or aqueous paste (paragraphs 0107-0118 & 0213: liquid phase),
wherein the first material comprises tetracalcium phosphate (A), alkali metal salt of phosphoric acid (B), and acidic calcium phosphate (C) (paragraph 0213: TTCP(A)/DCPA(C)/NaH2PO4(B)), and the second material comprises water (D) (paragraph 0213: Gelling CGP; see also paragraph 0108 & 0118);
(11) wherein the second material has a pH of greater than or equal to 6.0 (paragraphs 0118 & 0132); and
(14) wherein the first material is powder (paragraphs 0119-0129 & 0213: mineral phase), and the second material is liquid (paragraphs 0107-0118 & 0213: liquid phase).
The exemplary embodiment of Chaput et al. fails to disclose: (1) wherein at least one of the first material and the second material comprises a fluorine compound (E) and an organic acid (F) having a molecular weight of 10000 or less; (13) wherein the second material comprises the fluorine compound (E), and the organic acid (F) having a molecular weight of 10000 or less;
(2) wherein the fluorine compound (E) is at least one selected from the group consisting of sodium fluoride, potassium fluoride, sodium monofluorophosphate, and stannous fluoride; (3) wherein the fluorine compound (E) is sodium fluoride or potassium fluoride; and
(5) wherein the organic acid (F) having a molecular weight of 10000 or less is a polyvalent organic acid having two or more acidic groups; (6) wherein the organic acid (F) having a molecular weight of 10000 or less is at least one selected from the group consisting of citric acid, malonic acid, succinic acid, oxalic acid, malic acid, and tartaric acid; (7) wherein the organic acid (F) having a molecular weight of 10000 or less is citric acid.
However, the general teachings of Chaput et al. contemplate the use of these fluorine compounds, including sodium fluoride and potassium fluoride, as additives for their mineral phase (first material) (see paragraph 0125) and their liquid phase (second material) (see paragraph 0117). The general teachings of Chaput et al. also contemplate the use of these acids, including citric acid, as additives for their mineral phase (first material) (see paragraph 0139) and their liquid phase (second material) (paragraph 0132). In light of this, the skilled artisan would have obviously envisaged embodiments where (E & F) are both present in the mineral phase (first material) of Chaput et al. and/or embodiments where (E & F) are both present in the liquid phase (second material) of Chaput et al.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the exemplary embodiment of Chaput et al. with the instantly claimed (E & F) in the mineral phase (first material) and/or the liquid phase (second material) because: (a) the general teachings of Chaput et al. contemplate the use of the instantly claimed fluorine compounds (E), including sodium fluoride and potassium fluoride, as additives for their mineral phase (first material) and their liquid phase (second material); (b) the general teachings of Chaput et al. also contemplate the use of the instantly claimed acids (F), including citric acid, as additives for their mineral phase (first material) and their liquid phase (second material); and (c) in light of this, the skilled artisan would have obviously envisaged embodiments where (E & F) are both present in the mineral phase (first material) of Chaput et al. and/or embodiments where (E & F) are both present in the liquid phase (second material) of Chaput et al.
Regarding claim 9, the teachings of Chaput et al. are as set forth above and incorporated herein. Their exemplary embodiment fails to disclose: (9) wherein at least one of the first material and the second material further comprises salt of organic acid (G) having a molecular weight of 10000 or less. However, the general teachings of Chaput et al. contemplate the use of organic salts, including oxalates, malates and citrates, as additives for their mineral phase (first material) (see paragraph 0139).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the exemplary embodiment of Chaput et al. with the instantly claimed salt (G) because: (a) the general teaching of Chaput et al. contemplate the use of organic salts as additives for their mineral phase (first material); and (b) the organic salts of Chaput et al. include oxalates, malates and citrates.
Regarding claim 10, the teachings of Chaput et al. are as set forth above and incorporated herein. Their exemplary embodiment fails to disclose: (10) wherein at least one of the first material and the second material further comprises at least one selected from the group consisting of metal oxide particles and light anhydrous silicic acid particles which have an average particle diameter of 0.002 to 20 mm. However, the general teachings of Chaput et al. contemplate the use of metal oxides as additives for their mineral phase (first material) (see paragraph 0125). Furthermore, they disclose that their mineral phase (first material) has a preferred particle size of 1 to 20 mm (see paragraph 0141).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the exemplary embodiment of Chaput et al. with the instantly claimed particulate additive because: (a) the general teachings of Chaput et al. contemplate the use of metal oxides as additives for their mineral phase (first material); and (b) Chaput et al. disclose that their mineral phase (first material) has a preferred particle size of 1 to 20 mm.
Regarding claim 12, the teachings of Chaput et al. are as set forth above and incorporated herein. Chaput et al. fail to explicitly disclose: (12) wherein paste immediately after malaxation of the first material and the second material has a pH of greater than or equal to 5.5. Rather, Chaput et al. disclose that their liquid phase (second material) has a pH of 6.5-7.4 (see paragraphs 0118 & 0132). In light of this, the skilled artisan would have expected their overall composition to satisfy or obviously embrace embodiments satisfying the instantly claimed pH range because their mineral phase (first material) and their liquid phase (second material) satisfy all of the material/chemical limitations of the claimed invention. Furthermore, the medical procedures detailed by Chaput et al. (see paragraphs 0149-0158) would have likely required a relatively neutral pH for patient compatibility and safety.
Regarding claim 15-17, the teachings of Chaput et al. are as set forth above and incorporated herein. They fail to explicitly disclose: (15) wherein the tetracalcium phosphate (A) is in a form of particles, and has an average particle diameter of 0.5 to 40 mm; (16) wherein the alkali metal salt of phosphoric acid (B) is in a form of particles, and has an average particle diameter of 0.5 to 20 mm; and (17) wherein the acidic calcium phosphate (C) is in a form of particles, and has an average particle diameter of 0.1 to 7 mm. Rather, they disclose that their mineral phase (first material) has a preferred particle size of 1 to 20 mm (see paragraph 0141). In light of this, it has been found that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists – see MPEP 2144.05.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the exemplary embodiments of Chaput et al. with the instantly claimed particles sizes because: (a) Chaput et al. disclose that their mineral phase (first material) has a preferred particle size of 1 to 20 mm; and (b) it has been found that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.
Claims 4, 8, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Chaput et al. (US 2003/0199615 A1) in view of Poth et al. (DE 102006039631 A1).
Regarding claims 4, the teachings of Chaput et al. are as set forth above and incorporated herein. They fail to explicitly disclose: (4) wherein an amount of the fluorine compound (E) in terms of fluoride ions is 0.01 to 3% of an entire amount of the curable calcium phosphate dental cement.
Poth et al. disclose a related composition used for treating bones and teeth (see Abstract). They identify fluorine compounds as suitable for preventing cavities (see paragraph 0132). Furthermore, they disclose that these fluorine compounds are typically provided in amounts of from 0.1 to 0.5 wt% of fluorine (see paragraph 0132).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the composition Chaput et al. with the instantly claimed amount of fluorine compound (E) because: (a) Poth et al. disclose a related composition used for treating bones and teeth and identify fluorine compounds as suitable for preventing cavities; and (b) Poth et al. disclose that these fluorine compounds are typically provided in amounts of from 0.1 to 0.5 wt% of fluorine.
Regarding claim 8, the teachings of Chaput et al. are as set forth above and incorporated herein. They fail to disclose: (8) wherein a content of the organic acid (F) having a molecular weight of 10000 or less is greater than or equal to 0.005 parts by mass with respect to 100 parts by mass of the entire amount of the curable calcium phosphate dental cement.
Poth et al. disclose a related composition used for treating bones and teeth (see Abstract).
They disclose that citric acid can be used to adjust the pH when tartar inhibitors are used in the formulation (see paragraphs 0137-0139). This establishes that the amount of organic acid (F) would have been recognized as a result effective variable for this type of composition. In light of this, it has been found 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); and “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation,” –In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of organic acid (F) in the composition of Chaput et al. because: (a) Poth et al. disclose a related composition used for treating bones and teeth; (b) Poth et al. disclose that citric acid can be used to adjust the pH when tartar inhibitors are used in the formulation, which establishes that the amount of organic acid (F) would have been recognized as a result effective variable for this type of composition; (c) it has been found 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;” and (d) it has been found that “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation.”
Regarding claims 18 and 19, the teachings of Chaput et al. are as set forth above and incorporated herein. Chaput et al. contemplate the use of strontium salts and citrates in their composition (see paragraphs 0125-0126). They fail to explicitly disclose: (18) a dentifrice comprising the curable calcium phosphate dental cement; and (19) a dentinal hypersensitivity inhibitor comprising the curable calcium phosphate dental cement.
Poth et al. disclose a related composition used for treating bones and teeth (see Abstract). Poth et al. demonstrate that this type of composition is suitable for use as a dentifrice (see paragraphs 0131-0161). These include compositions that inhibit dentinal hypersensitivity with the use of strontium salts and citrates (see paragraphs 0140-0142 & 0148). In light of this, it has been found that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination – see MPEP 2144.07.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a dentifrice and a dentinal hypersensitivity inhibitor with the composition of Chaput et al. because: (a) Chaput et al. contemplate the use of strontium salts and citrates in their composition; (b) Poth et al. disclose a related composition used for treating bones and teeth and demonstrate that this type of composition is suitable for use as a dentifrice, including compositions that inhibit dentinal hypersensitivity with the use of strontium salts and citrates; and (c) it has been found that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J FEELY whose telephone number is (571)272-1086. The examiner can normally be reached Monday-Friday 8am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Randy Gulakowski can be reached at (571)272-1302. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL J FEELY/Primary Examiner, Art Unit 1766
March 27, 2026
Prosecution Insights