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 .
Applicants' arguments, filed 09/09/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Election/Restrictions
Newly submitted claims 24-27 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the product as claimed can be used in a materially different process of using that product. For example, a lightening mixture can be used to reduce particles size instead of ultrasonic vibrations.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 24-27 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 112—new by amendment
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 21-22 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 21-22 have been amended to replace the term “configured” with –sized--, however, there is no support for the term “sized” in the disclosure as originally filed. The specification discusses particle size but does not associate it with the particles ability to react with calcium (see p. 10, para. [49]). Accordingly, replacing configured with size constitutes new matter, as an unsupported concept.
112, 4th paragraph.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 28 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 28 depends from a withdrawn claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102--Previous
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, 4-12, 14, 22-23 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sagel et al., (US 9,717,665).
Sagel et al. teaches, “Desensitizing oral care composition useful for treating dentinal hypersensitivity, comprising potassium oxalate and methods thereof” (Abstract). The compositions are taught to be applied to the tooth structure via a dental strip for “sustained delivery of a desensitizing agent to a desirable area in the oral cavity, for a period of time sufficient to provide significant tubule blockage and subsequent sensitivity relief” (co. 2, lines 66-col. 3, line 2). This addresses the method step of applying to a tooth, as per claims 10-11, 21, 22.
The prior art claims:
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557
604
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(column 30, claim 1).
The prior art claims a specific embodiment comprising 3.14% potassium oxalate (active ingredient; oxalic acid potassium salt), 0.25% sodium hydroxide (solubility enhancer), and 58.05% water (col. 22, TABLE 1A, composition 1a).
Here the amount of sodium hydroxide is greater than 0.3 g/L (0.03%), as per claim 5, 17. It also falls within the claimed concentration range for the solubility enhancer, i.e., 0.1 to 6.0g/L (0.01 to 0.6%), as per claim 7, 19.
Since the prior art embodiment includes the same solubility enhancer, i.e., sodium hydroxide, with the active ingredient, it is expected to possess the same properties as claimed, i.e, increases the solubility of the active ingredient by at least 1.0 g/L at a given temperature, as per claim 4; and increases the solubility of the active ingredient to at least 26 g/L at 20ºC, as per claim 14.
Since the prior art embodiment utilizes water as a solvent, it qualifies as an aqueous solution, as per claim 8.
The active agent in the prior art embodiment, i.e., potassium oxalate, includes oxalate, as per claim 9.
The prior art is anticipatory insofar as it teaches solutions, and application of said solution to the tooth structure, comprising potassium oxalate, an active agent configured to react with the calcium in the tooth to produce a plurality of acid-resistance crystals that at least partially occlude dentinal tubules, and NaOH, a solubility enhancer for increasing the solubility of the active ingredient in the solution.
In regard to the sonication step, it is well settled, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (See MPEP 2113.)
In this case, Sagel et al. uses a “lightning mixer” as opposed to an ultrasonic mixture to “completely dissolve the added salts”, wherein the added salts include “potassium sorbate, potassium benzoate and potassium oxalate” (Example 1, col. 20, lines 30-33). Since the active ingredient, potassium oxalate, was completely dissolved, one would not expect evidence of a particle. The prior art therefore satisfies the claimed range of a reduced particle size of less than one micron on average. It also address the notion of sizing the active ingredient to react with calcium, as per claim 22
Claim Rejections - 35 USC § 102/103--Previous
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.
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) 1-5, 7-17, 19-23 remain rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Gerard et al., (WO 2015/140308).
Gerard et al. teaches “surface-reacted calcium carbonate” for “treating dentine hypersensitivity” (Abstract), wherein “an object of the present invention to provide a desensitizing agent that can migrate into the dentine tubules easily and remains in the tubules and occludes the tubules effectively for a long period after application” as well as “provide a desensitizing agent that is more resistant to acid challenge” (p. 2, lines 19-24).
Because the desensitizing agent remains in and occludes the tubules it is configured to react with calcium in the tooth.
“The particle size of the surface-reacted calcium carbonate can be tailored with respect to the dentine tubules to be treated. For example, in case of a human molar, wherein the dentine tubules typically have a diameter between 3 and 2 µm, the surface reacted calcium carbonate particles may have a volume median grain diameter (d50) of equal to or less than 3 µm” (p. 20, lines 15-19).
Here, providing particles of a particle size, in solution, less than one micron, on average, is anticipated where the dentine tubules of the patient are 1 micron.
For particle size distribution, “samples were dispersed using high speed stirrer and supersonics” (p. 32, lines 10-15). Here, the prior art teaches subjecting the particles to mechanical vibrations.
The compositions include additional desensitizing agents such as “potassium oxalate” (p. 23, lines 19-24), wherein “the additional desensitizing agent has a weight median particle size d50 from 0.1 to 100 µm, preferably from 0.5 to 50 µm” (Id. lines 27-29), as per claims 2-3. Again, providing particles of a particle size, in solution, less than one micron, on average, is anticipated where the diameter of the dentine tubules of the patient are 1 micron. Note: potassium oxalate is also known as oxalic acid potassium salt, as per claim 23.
“Preferably the surface-reacted calcium carbonate to be used in the present invention is prepared as an aqueous suspension having a pH, as measured at 20ºC, of greater than 6.0” (p. 13, lines 10-13), wherein the surface-reacted calcium carbonate “is suspended in water” and a concentration of “1 wt.% to 90 wt.%” (Id. lines 17-20).
The pH of the suspension can be “greater than 6 by adding a base subsequent to carbon dioxide treatment”, wherein “[a]ny conventional base such as sodium hydroxide or potassium hydroxide can be used” (p. 17, lines 15-18).
Since the only requirement for the composition is the presence of the surface reacted calcium carbonate (see Claim 1, for example), here, it would have been obvious for the compositions to consist of water, an active ingredient, and the conventional base, sodium hydroxide, to satisfy the limitations of claim 21.
The prior art is anticipatory insofar as it teaches a dental desensitizing solution comprising water, an active agent for occluding dentinal tubules, and sodium hydroxide, where the particle size of the active agent is less than 1 micron on average, according to the diameter dentinal tubules of the patient being treated.
Assuming that the prior art is insufficiently described to rise to the level of anticipation, it would have been obvious to provide a suspension of water, an active agent for occluding dentinal tubules with an average particle size of less than 1 micron, and sodium hydroxide, given the teaching above.
Concerning the amended “wherein/whereby clauses”: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (See MPEP 2113.)
In regard to claims 15-20, the transitional phrase “consisting essentially of" limits the scope of the claim to components that do not materially affect the basic and novel characteristics of the claimed invention (MPEP 2111.03; In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976)). However, there do not appear to be components described in the prior art that would materially affect the basic and novel characteristics of the claimed invention. There also does not appear to be a clear indication in the instant disclosure of what components would materially affect the basic and novel characteristics of the claimed invention. Accordingly, "consisting essentially of" will be construed as equivalent to “comprising".
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.
Previous
1) Claim(s) 1-20, 22-23 remain rejected under 35 U.S.C. 103 as being unpatentable over Sagel et al., (US 9,717,665) in view of Gerard et al., (WO 2015/140308) and further in view of Cox (WO 00/48562).
Sagel et al. teaches, “Desensitizing oral care composition useful for treating dentinal hypersensitivity, comprising potassium oxalate and methods thereof” (Abstract). The compositions are taught to be applied to the tooth structure via a dental strip for “sustained delivery of a desensitizing agent to a desirable area in the oral cavity, for a period of time sufficient to provide significant tubule blockage and subsequent sensitivity relief” (co. 2, lines 66-col. 3, line 2). This addresses the method step of applying to a tooth, as per claims 10-11, 21, 22.
The prior art claims:
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557
604
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(column 30, claim 1).
The prior art claims a specific embodiment comprising 3.14% potassium oxalate (active ingredient; oxalic acid potassium salt), 0.25% sodium hydroxide (solubility enhancer), and 58.05% water (col. 22, TABLE 1A, composition 1a).
Here the amount of sodium hydroxide is greater than 0.3 g/L (0.03%), as per claim 5, 17. It also falls within the claimed concentration range for the solubility enhancer, i.e., 0.1 to 6.0g/L (0.01 to 0.6%), as per claim 7, 19.
Since the prior art embodiment includes the same solubility enhancer, i.e., sodium hydroxide, with the active ingredient, it is expected to possess the same properties as claimed, i.e, increases the solubility of the active ingredient by at least 1.0 g/L at a given temperature, as per claim 4; and increases the solubility of the active ingredient to at least 26 g/L at 20ºC, as per claim 14.
Since the prior art embodiment utilizes water as a solvent, it qualifies as an aqueous solution, as per claim 8.
The active agent in the prior art embodiment, i.e., potassium oxalate, includes oxalate, as per claim 9.
The prior art teaches solutions, and application of said solution to the tooth structure, comprising potassium oxalate, an active agent configured to react with the calcium in the tooth to produce a plurality of acid-resistance crystals that at least partially occlude dentinal tubules, and NaOH, a solubility enhancer for increasing the solubility of the active ingredient in the solution.
Sagel et al. does not teach a particle size for the potassium oxalate.
Gerard et al. teaches “surface-reacted calcium carbonate” for “treating dentine hypersensitivity” (Abstract), wherein “an object of the present invention to provide a desensitizing agent that can migrate into the dentine tubules easily and remains in the tubules and occludes the tubules effectively for a long period after application” as well as “provide a desensitizing agent that is more resistant to acid challenge” (p. 2, lines 19-24).
“The particle size of the surface-reacted calcium carbonate can be tailored with respect to the dentine tubules to be treated”, e.g. “the surface reacted calcium carbonate particles may have a volume median grain diameter (d50) of equal to or less than 3 µm” (p. 20, lines 15-19).
The compositions include additional desensitizing agents such as “potassium oxalate” (p. 23, lines 19-24), wherein “the additional desensitizing agent has a weight median particle size d50 from 0.1 to 100 µm, preferably from 0.5 to 50 µm” (Id. lines 27-29), as per claims 2-3.
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to provide potassium oxalate with an average particle size of less than 1 micron in an effort to tailor the particles with respect to the dentine tubules to be treated, as well as providing 0.1 or 0.5 µm based on the suitability of having potassium oxalate within the prior art ranges of 0.1 to 100 µm, preferably from 0.5 to 50 µm, as taught by Gerard et al.
Additionally, Cox teaches use of “a solution of oxalic acid potassium salt, dihydrate 99% to react with calcium in the dentinal fluid forming an insoluble white precipitated of calcium oxalate which occludes dentinal tubules causing decreased sensitivity, permeability and acid penetration of the dentin”, wherein the “oxalic acid potassium, dihydrate 99% has “a particle size of about 1 to 10 microns when view by a 100 power microscope” (Abstract).
According to Cox, water and oxalic acid potassium salt, dihydrate crystals are “subjected to variable ultra high frequency wave action to disintegrate the crystals into very small particles to form a solution” (p. 5, last paragraph). Further, “[i]n use, the preferred vibrations provide ultra sonic disassociation at a frequency of about 16,000 Hz to about 20,000 Hz at the tip of the ultrasonic horn as it disrupts and disintegrates the crystals into very small particles so that they go into solution” (p. 6, 1st paragraph).
Accordingly, it would have also been obvious to use oxalic acid potassium salt dihydrate as the potassium oxalate, as well as subject the particles to ultrasonic or mechanical vibrations in solution to solubilize the particles, as taught by Cox.
Note: sodium hydroxide is described as a pH adjusting agent in Sagel et al., and may be present “from about 0.001% to about 10%”, making obvious the claimed range of 0.3 ot 1.5 g/L, as per claim 19, for the solubility enhancer.
In regard to claims 15-20, the transitional phrase “consisting essentially of" limits the scope of the claim to components that do not materially affect the basic and novel characteristics of the claimed invention (MPEP 2111.03; In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976)). However, there do not appear to be components described in the prior art that would materially affect the basic and novel characteristics of the claimed invention. There also does not appear to be a clear indication in the instant disclosure of what components would materially affect the basic and novel characteristics of the claimed invention. Accordingly, "consisting essentially of" will be construed as equivalent to “comprising".
New by Amendment
2) Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gerard et al., (WO 2015/140308).
Gerard et al. teaches “surface-reacted calcium carbonate” for “treating dentine hypersensitivity” (Abstract), wherein “an object of the present invention to provide a desensitizing agent that can migrate into the dentine tubules easily and remains in the tubules and occludes the tubules effectively for a long period after application” as well as “provide a desensitizing agent that is more resistant to acid challenge” (p. 2, lines 19-24).
Because the desensitizing agent remains in and occludes the tubules it is configured to react with calcium in the tooth.
“The particle size of the surface-reacted calcium carbonate can be tailored with respect to the dentine tubules to be treated. For example, in case of a human molar, wherein the dentine tubules typically have a diameter between 3 and 2 µm, the surface reacted calcium carbonate particles may have a volume median grain diameter (d50) of equal to or less than 3 µm” (p. 20, lines 15-19).
Here, providing particles of a particle size, in solution, less than one micron, on average, is anticipated where the dentine tubules of the patient are 1 micron.
For particle size distribution, “samples were dispersed using high speed stirrer and supersonics” (p. 32, lines 10-15). Here, the prior art teaches subjecting the particles to mechanical vibrations.
Since the only requirement for the composition is the presence of the surface reacted calcium carbonate (see Claim 1, for example), here, it would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing for the compositions to consist of water, an active ingredient, and the conventional base, sodium hydroxide, to satisfy the limitations of claim 21.
Technological Background
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure Knowde (VYNOVA Renewable Caustic Soda). Knowde is pertinent for teaching synonyms and functions of sodium hydroxide. Of particular interest is the teaching that sodium hydroxide functions as a “Solubility Enhancer” (see Functions at p. 1).
Response to Arguments
i) Applicant postulates, “the application has discovered that reducing the size of the active ingredient to an average size of less than one micron, not heretofore disclosed or achieved, configures the active ingredient to actually react with the calcium in the tooth” (p. 8).
However, the Examiner is unable to find any support in the disclosure for the notion the reduction in particle size, i.e., less than on micron, enables the active to react with calcium. It is well settled that the arguments of counsel cannot take the place of evidence in the record (see MPEP 2145 relying on In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)).
Use of sonication to reduce particle size of or potassium oxalate particles is well-established in the art, as taught by WO 00/48562. The reference teaches, “Dissolving the potassium oxalate dihydrate in water may be difficult under conventional practices, however, the product of the present invention is subjected to ultrasonic frequencies to disperse the large crystals of the potassium oxalate in water and therefore solubilize in water” (p. 5, first full paragraph).
In regard to particle size for the purpose of occluding dentinal tubules, it is known to adjust the particle size of the occluding agent to correspond to the size of the tubules in a tooth structure as taught by Gerard et al., i.e., “The particle size of the surface-reacted calcium carbonate can be tailored with respect to the dentine tubules to be treated. For example, in case of a human molar, wherein the dentine tubules typically have a diameter between 3 and 2 µm, the surface reacted calcium carbonate particles may have a volume median grain diameter (d50) of equal to or less than 3 µm” (p. 20, lines 15-19). In situations where the tubules have a 1 micron diameter, the artisan would have reasonably been expected to reduce particle size of the active to correspond to the diameter of the tubule, e.g. a median grain diameter (d50) of equal to or less than 1 µm.
Conclusion
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.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Frederick F. Krass can be reached (571) 272-0580. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/Primary Examiner, Art Unit 1612