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 .
Applicant’s amendment and argument of 5/15/26 is entered.
Claims 1, 4-5, and 8 are amended.
Claim 3 is canceled.
Claims 9-10 are newly presented.
Claims 1-2 and 4-10 are pending and considered herein.
Claim Status, Canceled Claims
In light of the cancelation of Claim 3, all rejections/objections thereto, are withdrawn.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 5, and 8 is/are again rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication No. 2019/0282675 A1 to Misako, et al., published more than a year before Applicant’s earliest filing date.
Claim(s) 1-2, 5, and 8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent Publication No. 2019/0282675 A1 to Misako, et al.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim 1: Misako teaches crushing tooth into grains, to obtain fine dentin particles having about 500-1000 micrometer size, which are separated by a sieve. This is done in the context of inducing dentin by dental pulp stem cells (Example 2). The context of this is to then treat dogs’ with root canals (Example 3). The same is taught to be done for humans (paragraph 61), which is taught with human dental pulp (e.g. Example 8). These examples are taught in the context of treating humans (e.g., paragraph 4 and 26). Example 2 teaches the demineralization with EDTA in 1mM EDTA.
Claim 2: as above, the particles are 500-1000 micrometers in size.
Claim 5: Example 2 teaches 1 mM EDTA for demineralization.
Claim 8: The composition is made and cultured (Example 2).
Response to Argument – 102, Misako
Applicant’s argument of 5/15/26 has been considered but is not found persuasive.
Applicant argues that the Misako treatment with 1mM EDTA is not properly construed as a demineralization process. To wit, the specification explains it as eluting calcium salt crystals from the enamel, that strong acid and chelating agent distinguishes the methods, and working examples teach example concentrations of 1-30% by weight, including 3 weight percent, and 17 weight percent, or the use of strong acids, citing the specification, and thus, it is argued that the treatment of Misako is not meaningful to the removal of calcium phosphate from the enamel (pp. 4-5, paragraph bridging.
Such is not persuasive. The specification is written in open ended fashion, and as noted by newly-presented claims 9-10, which are to 1-30 weight percent, indicates the broad claims encompass more, and as seen by Claim 5, it may be an ethylene diamine. Finally, it is impossible to argue that at least some demineralization did not take place in the methods of Misako.
Applicant argues that Misako’s description confirms it is not used as demineralizing agent, citing the specification, and attributes the observed biological effect to release and activation of matrix-bound factors, rather than structural modification of dentin (p. 5, paragraph 2).
Such is not persuasive. The intent does not matter, and the speculations on the effects is speculation. The fact is, the demineralization process occurred to some extent, and it was done with EDTA. Intent does not change the fact that the EDTA was used. Even Applicant states “… EDTA is not acting as a primary structural modifier of the dentin surface” (p. 5, paragraph 2, last sentence). Clearly if it is not a primary structural modifier, it is still a structural modifier by Applicant’s admission.
Applicant recaps, stating that the mechanism is fundamentally distinct, and is different from Applicant’s use (pp. 5-6, paragraph bridging).
Such is not persuasive. The claim limitations are met, and thus, the claims are anticipated.
Applicant argues that their arguments are reinforced by the use of 0.029224 weight percent of EDTA which is orders of magnitude lower, and the specification teaches 1-30 weight percent (p. 5, paragraph 2).
Such is not persuasive. As discussed above, Applicant’s range is open-ended, meaning more or less may be used. Furthermore, Applicant has now claimed 1-30 weight percent in a depending claim, meaning the claims are intended to an even greater range, including less than 1 weight percent. There is no reason to believe the claims do not embrace 0.029 weight percent.
Applicant argues that Misako does not provide a treatment that necessarily results in demineralization, that there is no evidence it results in such, and contrarily, their own specification teaches a process that does result in demineralization (p. 5, paragraph 3).
Such is not persuasive. The Examiner does not have the facilities and resources to determine if and how much demineralization took place. The claims clearly encompass less than 1 weight percent. The claims clearly teach EDTA. It is presumed because the structure is there, at least some demineralization took place.
Applicant argues again, that the Misako teaches a different mechanism in the use of EDTA, and it is fundamentally distinct from the demineralization process of Applicant’s specification (pp. 5-6, paragraphs bridging).
Such is not persuasive. Misako still adds the EDTA to treat it, and there is no reason to believe at least some demineralization took place. Moreover, Applicant’s claims are not limited to the specification and due to the new claims clearly encompass less than 1 weight percent.
Applicant argues that Misako’s 1mM is 0.029 weight/vol percent, and is orders of magnitude lower than 1 weight percent claimed by Applicant, and teaches a distinct biological effect from Misako (p. 6, paragraph 2).
Such is not persuasive. Applicant’s claims are not limited the specific range listed in the specification, and the specification is written in open-ended language. Applicant now claims 1-3 weight percent. This indicates more is encompassed by the other claims. And taught mechanisms does not mean the other mechanisms do not take place. Lastly, intended use is considered in the structure of the claim.
Applicant agues that inherency arguments do not follow, as the specification teaches “meaningful” demineralization does not take place (p. 6, paragraph 3).
Such is not persuasive. The term “meaningful” is subjective, and because the processes occur, they occur.
Applicant argues advantageous effects take place in their method (pp. 6-7, paragraph bridging).
Such is not persuasive. The steps take place, and thus it is anticipated. The effects are presumed to have taken place as the structure is there, even if it isn’t up to what is argued by Applicant. Moreover, the claims are not so-limited and the new claims indicate that the rejected specifically encompass less than 1 weight percent.
Applicant argues that the specific effects on the directional elongation and organization of the dentin as in Example 3 (p. 7, paragraph 2).
Such is not persuasive. Applicant’s claims encompass less than the amount of EDTA used in the example.
Applicant argues in vivo results confirm the same (p. 7, paragraph 3).
Such is not persuasive. Applicant’s claims encompass less than the amount of EDTA used in the example.
Applicant argues the reasoning above demonstrates Misako is not anticipating (p. 7, paragraph 4).
Such is not persuasive. For the reasoning above provided, the claims are anticipating.
Applicant argues for similar reasoning Claim 8 is not anticipated (pp. 7-8, paragraphs bridging).
Such is not persuasive for the responses above.
Applicant argues Miskao uses 1mM EDTA and does not provide for the claimed demineralization process, for the reasoning above (p. 8, paragraph 2).
Such is not persuasive. As shown above, the chemistry is such that at least some demineralization took place. Even at orders of magnitude lower, some demineralization necessarily takes place, its basic chemistry.
Applicant argues Misako does not disclose conditions indicative of demineralization (p. 8, paragraph 3).
Such is not persuasive. Miskao did the step, the demineralization is assumed to have taken place to some extent.
Applicant returns to inherency and states there is no evidence it took place (p. 8, paragraph 4).
Such is not persuasive. The step took place, and so it is presumed to have taken place to some extent.
Applicant argues that the claim 8 is to a composition that achieves the same advantages as found in examples 1-3, and Miskao does not disclose the same (p. 8, paragraph 5).
Such is not persuasive. The steps took place, and the advantages are irrelevant. The examples are not limiting on the claims.
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) 1-2, 4-5 and 8 is/are again rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2019/0282675 A1 to Misako, et al. and U.S. Patent Application Publication No. 2009/017184 A1 to Murata, et al.
As shown above, the base claims are anticipated by the base art. However, the aspect of utilizing a 0.4-1.0 Normal strong acid as a demineralization solution, is not taught by Misako’s 2019/0282675 Publication.
On the other hand, it has long been known to do so in the art, at the time of invention. For example, 10-20% HCl or HNO3 is known to be utilized for decalcifying teeth in Misako’s 2009/0176184 Publication (e.g., paragraph 24).
Thus, the invention is obvious. The Artisan would do so as another method of decalcifying the ground teeth. The Artisan would expect success, as the components are utilized for art-recognized purposes.
Response to Argument – 103, Misako and Murata
Applicant’s argument of 5/15/26 has been considered but is not found persuasive.
Applicant argues that Murata does not overcome the deficiencies in Misako (p. 9, paragraph 2).
Such is not persuasive. As shown above, Miskao does not have such deficiencies.
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) 1-2 and 5-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2019/0282675 A1 to Misako, et al. and U.S. Patent Publication No. 2018/0296445 A1 to Amao, et al., JP Publication No. 11-228328 to Abiru, et al. (machine translation), and JP Pub. No. 2018-131456 to Takahashi.
As shown above, the base claims are rejected over the base art alone, but the aspects of immersion in alcohol comprising silver ions as an antimicrobial agent and drying.
On the other hand, in making such preparations, silver ions are well known in the art, as antimicrobial for such purposes (e.g., Amao, paragraphs 90-94; Abiru, paragraph 10 and Claim 2; and Takahashi, paragraphs 27-29 and Claim 1).
Thus, at the time of invention, the invention was obvious. The Artisan would do so to make material for treatment of root canals in dogs and humans. The Artisan would expect success, as it is claimed.
Response to Argument – Misako, Amao, Abiru and Takahashi
Applicant’s argument of 5/15/26 has been considered but is not found persuasive.
Applicant argues that the additional art does not overcome the deficiencies in Misako (p. 9, paragraph 4).
Such is not persuasive. As shown above, Misako does not have such deficiencies.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4-6 and 8-10 are newly is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2012/121448 A1 to Kim, as necessitated by amendment.
Claim 1: Kim teaches bone graft substitutes provided by grinding up teeth into a powder, and treatment with EDTA (e.g., ABSTRACT). The teeth used includes the use of human teeth (e.g., section “MODE-FOR-INVENTION”, paragraph 7). Example 6 teaches the use of 2% (wt) EDTA treating the crushed tooth powder.
Claim 2: Kim teaches ground tooth diameters of 0.1-2 mm (e.g., section “TECH-SOLUTION”).
Claim 4: Kim teaches the use of 2% sulfuric acid (e.g., Example 5), which is 0.41 normal H2SO4.
Claim 5: as above, Kim teaches EDTA.
Claim 6: Kim teaches the use of ethanol, which is antibacterial (e.g., ABSTRACT). Moreover, antibiotics may be used (e.g., section “MODE-FOR-INVENTION”, paragraph 10).
Claim 8: as shown above, the process is performed to produce the compositions.
Claims 9-10: EDTA may be 2% (wt) (e.g., Example 6).
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638
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