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 included in the prosecution are claims 1-20.
Applicants' arguments, filed 09/18/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Objections
Claim 9 is objected to because of the following informalities: reciting both “at least one” and “and a combination thereof” in the second and third line, respectively, are redundant. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the term “a” should be recited immediately prior to “material comprising one or more hydrocarbon waxes”. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: “watersoluble” in the fourth line should be recited as --- water soluble ---. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9 and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites wherein the combination of dry, powdered material may comprise an arginine component other than arginine bicarbonate. Claim 9 depends from claim 7 which recites where the combination of dry, powdered material comprises arginine bicarbonate. The claim is indefinite since it is not clear whether arginine bicarbonate is a required ingredient.
Claim 17 recites wherein no more than 0.1% by weight of the precipitated calcium carbonate would not pass through a 325 mesh. A 325 mesh is 44 microns. Thus, the claim is reciting wherein 0.1% or less of precipitated calcium carbonate would not pass through a 44 micron mesh. The claim is indefinite since the precipitated calcium carbonate has an average particle size of 1-5 microns. Thus, at least 50% of the precipitated calcium carbonate would pass through a 44 micron mesh, which conflicts with the limitation of 0.1% or less of precipitated calcium carbonate not passing through a 44 micron mesh.
Claim Rejections - 35 USC § 112(d)
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 10 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 10 fails to further limit the subject matter of claim 7 since claim 10 recites at least 50% xanthan gum, while claim 7 limits the amount of xanthan gum to at least 80%.
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 § 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
1. Claims 1, 2, 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Hannapel et al. (US 9,987,103, Jun. 5, 2018) (hereinafter Hannapel) in view of Schutt et al. (US 10,391,040, Aug. 27, 2019) (hereinafter Schutt), Budde et al. (US 2017/0105911, Apr. 20, 2017) (hereinafter Budde) and Munk (US 4,735,569, Apr. 5, 1988).
Hannapel discloses an orthodontic protection device for one tooth of a user including: a finger moldable base material and a plurality of beads that form an adhesive layer on a facial surface of the base layer wherein the beads comprise at least one hygroscopic polymeric material (col. 2, lines 31-41). The moldable material can comprise a polymeric material (col. 5, lines 66-67). Suitable polymeric materials include a silicone high consistency rubber base (col. 6, line 17). The moldable material can be partially or completely coated on at least one surface with an adhesive layer (col. 6, lines 62-63). The hygroscopic polymeric material is typically dehydrated. Moisture is lost until the adhesive layer is non-tacky (col. 7, lines 8-15). Suitable hydratable hygroscopic polymeric materials include xanthan gum (i.e., water-soluble polymeric adhesive) (col. 7, line 27). The adhesive layer may be dehydrated after it is applied to the at least one surface of the moldable material (col. 2, lines 52-54). The moisture loss during dehydration may be 100% (i.e., anhydrous) (col. 7, lines 10-12). Typically, moisture is lost until the adhesive layer is non-tacky (col. 7, lines 14-15). The adhesive layer may comprise sodium fluoride (col. 7, line 50). Fig. 4A shows wherein the device comprises a plurality of grooves on the surface of the finger moldable base material and wherein the plurality of beads that form the adhesive layer are around or within the plurality of grooves. In some instances, the device may have a flat surface lacking a groove (col. 9, lines 6-7). The recess may be any desired shape. The shape is not critical (col. 11, lines 4-10). Various lengths of the device and various shapes are contemplated (col. 5, lines 25-26). The base material may comprise one or more food safe color pigments (col. 6, lines 27-29). Most typically, the applier of the device will apply finger pressure for about 5 seconds, which in most every instance will cause the device to adhere (col. 8, lines 42-45). One uses fingertip force to remove the orthodontic protection device from engagement with a brace (claim 17).
Hannapel differs from the instant claims insofar as not disclosing wherein the silicone high consistency rubber base is uncured and uncrosslinked.
However, Schutt discloses orthodontic protection devices comprising an uncured (uncrosslinked) silicone HCR base and an adhesive (col. 4, lines 50-65). The adhesive formulation may include one or more actives (col. 11, lines 53-54).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Hannapel discloses wherein the device comprises a silicone high consistency rubber base. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated an uncured (uncrosslinked) silicone high consistency rubber base into the device of Hannapel since it is a known and effective type of silicone high consistency rubber base for orthodontic compositions as taught by Schutt.
The combined teachings of Hannapel and Schutt do not teach wherein the device comprises arginine, calcium carbonate, and/or potassium nitrate.
However, Budde discloses an oral composition comprising surface-reacted calcium carbonate for remineralization and/or whitening of teeth (abstract). The synthetic calcium carbonate is precipitated calcium carbonate (¶ [0048]). The surface-reacted calcium carbonate has a volume median grain diameter of equal to or less than 15 µm and a volume determined top cut particle size of equal to or less than 25 µm (¶ [0019]). The composition may comprise mixtures of potassium nitrate and arginine as a desensitizing agent (¶ [0020]). The oral care composition comprises from 1 to 40 wt.-%, of the surface-reacted calcium carbonate (¶ [0022]).
Schutt taught wherein the adhesive of orthodontic protection devices may comprise one or more actives. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated potassium nitrate (i.e., hypersensitivity desensitization ingredient), arginine and/or 1 to 40 wt. % surface-reacted calcium carbonate having a volume median grain diameter of equal to or less than 15 µm into the adhesive of the orthodontic protection device of Hannapel since it is desirable in the art to have the adhesive comprise one or more actives as taught by Schutt and potassium nitrate, arginine, and/or 1 to 40 wt. % surface-reacted calcium carbonate having a volume median grain diameter of equal to or less than 15 µm are known and effective actives as taught by Budde.
The combined teachings of Hannapel, Schutt, and Budde do not teach wherein the plurality of beads that form the adhesive layer are mechanically engaged with and dispersed on one or more surfaces of the finger malleable base material.
However, Munk discloses that in affixing an orthodontic bracket to a tooth, it is important that the dental adhesive be pressed into the annular recess as opposed to allowing it to just flow thereinto during a coating or painting of the rear surface, to insure a good mechanical or physical bond between the adhesive and the undercut portions of the annular recess (col. 6, lines 6-12).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have the plurality of beads that form the adhesive layer pressed into (i.e., mechanically engaged) and dispersed on one or more surfaces of the finger malleable base material in order to insure good mechanical or physical bond between the adhesive and the base material, which is important as taught by Munk.
In regard to instant claim 1 reciting a dental composition for the desensitization and covering of an area of a human tooth, this is merely a recitation of the intended use of the claimed composition. As discussed above, Hannapel discloses an orthodontic protection device for one tooth of a user and it would have been obvious to one of ordinary skill in the art to have incorporated arginine into the device as a desensitizing agent. As such, the composition of the prior art is usable for desensitization and for covering of an area of a human tooth, whether the prior art discloses such use or not.
In regard to instant claim 1 reciting a combination of dry, powdered materials, as discussed above, the adhesive layer of the device is dehydrated and comprises xanthan gum and potassium nitrate, arginine, and/or calcium carbonate. All of these compounds exist as solids. As such, a combination of dry, powdered materials would have been obvious.
In regard to instant claim 4 reciting an amount of potassium nitrate, since potassium nitrate is a desensitizing agent, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount through routine experimentation based on the level of desensitizing desired. Where 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. See MPEP 2144.05(II)(A).
In regard to instant claim 5 reciting wherein the finger malleable base material includes a plurality of substantially V-shaped microgrooves disposed on a surface of the finger malleable base material, as discussed above, Hannapel discloses wherein the recess/groove may be any desired shape and the shape is not critical. Therefore, it would have been obvious to one of ordinary skill in the art to select any groove shape desired.
In regard to instant claim 5 reciting the plurality of microgrooves being five or fewer in number, as discussed above, Hannapel discloses wherein various lengths of the device are contemplated. Accordingly, the claimed number of grooves would have been obvious depending on the length of the device desired.
2. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hannapel et al. (US 9,987,103, Jun. 5, 2018) (hereinafter Hannapel) in view of Schutt et al. (US 10,391,040, Aug. 27, 2019) (hereinafter Schutt), Budde et al. (US 2017/0105911, Apr. 20, 2017) (hereinafter Budde), Munk (US 4,735,569, Apr. 5, 1988), and further in view of Robinson et al. (US 2013/0224270, Aug. 29, 2013) (hereinafter Robinson).
The teachings of Hannapel, Schutt, Budde, and Monk are discussed above. Hannapel, Schutt, Budde, and Monk do not teach wherein the device comprises arginine bicarbonate.
However, Robinson discloses an oral care composition comprising a basic amino acid or salt thereof (abstract). The basic amino acid in free or salt form may be arginine bicarbinate (¶ [0007]). Arginine and other basic amino acids have been proposed for use in oral care and are believed to have significant benefits in combating cavity formation and tooth sensitivity (¶ [0002]).
Schutt taught wherein the adhesive of orthodontic protection devices may comprise one or more actives. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated arginine bicarbonate into the adhesive of the orthodontic protection device of Hannapel since it is desirable in the art to have the adhesive comprise one or more actives as taught by Schutt arginine bicarbonate is a known and effective active as taught by Robinson.
In regard to instant claim 3 reciting wherein the arginine component consists of arginine bicarbonate, since Schutt teaches wherein the adhesive of orthodontic protection devices may comprise one or more actives, any number of actives may be incorporated. Thus, one may exclude arginine.
In regard to instant claim 3 reciting an amount of arginine bicarbonate, since arginine bicarbonate combats cavity formation and tooth sensitivity, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount through routine experimentation based on the level of cavity and tooth sensitivity inhibition desired. Where 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. See MPEP 2144.05(II)(A).
3. Claims 6, 12-15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hannapel et al. (US 9,987,103, Jun. 5, 2018) (hereinafter Hannapel) in view of Schutt et al. (US 10,391,040, Aug. 27, 2019) (hereinafter Schutt), Budde et al. (US 2017/0105911, Apr. 20, 2017) (hereinafter Budde), Munk (US 4,735,569, Apr. 5, 1988), and further in view of Chasanoff et al. (US 4,050,156, Sep. 27, 1977) (hereinafter Chasanoff).
The teachings of Hannapel, Schutt, Budde, and Monk are discussed above. Hannapel, Schutt, Budde, and Monk do not teach wherein the finger malleable base material is tooth colored by one or more metal oxide pigments dispersed therein.
However, Chasanoff discloses a dental applicance which features a metallic base material and a coating comprising a pigment for providing a tooth colored appearance. One typical pigment useful in providing the tooth coloring for the coating is TiO2 (col. 1, lines 58-68).
As discussed above, Hannapel disclosed wherein the base material may comprise a pigment. Accordingly, it would have been obvious to one of ordinary skill in the art to have dispersed TiO2 into the finger malleable base material since tooth colored dental appliances are desirable and TiO2 is a known and effective pigment for tooth coloring as taught by Chasanoff.
In regard to instant claim 6 reciting wherein the dental composition remains adhered to the area of the human tooth for at least four hours, Hannapel discloses wherein one uses fingertip force to remove the composition. Thus, since fingertip force is used to remove the composition, the composition may be adhered until one decides to use fingertip force, which may be over four hours.
In regard to instant claims 6 and 14 reciting wherein the combination of dry, powdered materials a blend of free-flowing solid particulate powders, as discussed above, Hannapel discloses wherein the adhesive layer is non-tacky. Thus, it would have been obvious to one of ordinary skill in the art that the plurality of beads that form the adhesive layer is free-flowing.
In regard to instant claim 15 reciting wherein the combination of dry, powdered materials is entirely water soluble, since Schutt teaches wherein the adhesive of orthodontic protection devices may comprise one or more actives, any number of known actives may be incorporated. Thus, one may only incorporate potassium nitrate as the active into the adhesive layer comprising xanthan gum. Potassium nitrate and xanthan gum are both entirely water-soluble. Thus, the claim limitation would have been obvious.
In regard to instant claim 20 reciting wherein the plurality of grooves contains up to ten grooves, Hannapel discloses in col. 5, lines 25-26 wherein various lengths of the device are contemplated. Accordingly, the claimed number of grooves would have been obvious depending on the length of the device desired.
4. Claims 7-11 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Hannapel et al. (US 9,987,103, Jun. 5, 2018) (hereinafter Hannapel) in view of Schutt et al. (US 10,391,040, Aug. 27, 2019) (hereinafter Schutt), Budde et al. (US 2017/0105911, Apr. 20, 2017) (hereinafter Budde), Munk (US 4,735,569, Apr. 5, 1988), Chasanoff et al. (US 4,050,156, Sep. 27, 1977) (hereinafter Chasanoff), and further in view of Robinson et al. (US 2013/0224270, Aug. 29, 2013) (hereinafter Robinson).
The teachings of Hannapel, Schutt, Budde, Monk, and Chasanoff are discussed above. Hannapel, Schutt, Budde, Monk, and Chasanoff do not teach wherein the device comprises arginine bicarbonate.
However, Robinson discloses an oral care composition comprising a basic amino acid or salt thereof (abstract). The basic amino acid in free or salt form may be arginine bicarbinate (¶ [0007]). Arginine and other basic amino acids have been proposed for use in oral care and are believed to have significant benefits in combating cavity formation and tooth sensitivity (¶ [0002]).
Schutt taught wherein the adhesive of orthodontic protection devices may comprise one or more actives. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated arginine bicarbonate into the adhesive of the orthodontic protection device of Hannapel since it is desirable in the art to have the adhesive comprise one or more actives as taught by Schutt arginine bicarbonate is a known and effective active as taught by Robinson.
In regard to instant claim 7 reciting the amount of xanthan gum, since xanthan gum provides adhesion, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount through routine experimentation based on the level of adhesion desired. Where 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. See MPEP 2144.05(II)(A).
In regard to instant claim 8 reciting wherein the at least one dental tubule blocking agent or hypersensitivity desensitization ingredient is arginine bicarbonate, since Schutt teaches wherein the adhesive of orthodontic protection devices may comprise one or more actives, any number of actives may be incorporated. Thus, one may only include arginine bicarbonate.
In regard to instant claims 10 and 11 reciting wherein the dry, powdered materials comprise arginine, arginine bicarbonate, and potassium nitrate, since arginine, arginine bicarbonate, and potassium nitrate are all known desensitizing agent, the use of the individual species in combination would have been obvious since it is prima facie obvious to combine two compositions, each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose; the idea for combining them flows logically from their having been individually taught in the prior art. See MPEP 2144.06.
In regard to instant claim 10 reciting an amount of arginine bicarbonate, since arginine bicarbonate combats cavity formation and tooth sensitivity, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount through routine experimentation based on the level of cavity and tooth sensitivity inhibition desired. Where 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. See MPEP 2144.05(II)(A).
In regard to instant claim 10 reciting an amount of arginine, since arginine is a desensitizing agent, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount through routine experimentation based on the level of desensitizing desired.
In regard to instant claim 11 reciting an amount of potassium nitrate, since potassium nitrate is a desensitizing agent, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount through routine experimentation based on the level of desensitizing desired. Where 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. See MPEP 2144.05(II)(A).
In regard to instant claim 17 reciting wherein no more than 0.1% by weight of the precipitated calcium carbonate would not pass through a 325 mesh, the instant specification discloses in paragraph [0085] wherein the particles are small, e.g., having an average particle size of 1-5 microns, and e.g., no more than 0.1%, preferably no more than 0.05% by weight of particles which would not pass through a 325 mesh. The particles may for example have a D50 of 3-6 microns, a D50 of 1-4 microns, and a D10 of 1-2 microns. Budde discloses in paragraph [0019] a D50 of 3-7 microns. Thus, since Budde discloses a particle size range that overlaps with the claimed invention, the precipitated calcium carbonate of the prior art would necessarily pass through or not pass through the same mesh as the claimed invention.
5. Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Hannapel et al. (US 9,987,103, Jun. 5, 2018) (hereinafter Hannapel) in view of Schutt et al. (US 10,391,040, Aug. 27, 2019) (hereinafter Schutt), Budde et al. (US 2017/0105911, Apr. 20, 2017) (hereinafter Budde), Munk (US 4,735,569, Apr. 5, 1988), Chasanoff et al. (US 4,050,156, Sep. 27, 1977) (hereinafter Chasanoff), Robinson et al. (US 2013/0224270, Aug. 29, 2013) (hereinafter Robinson), and further in view of Pilgaonkar et al. (US 2014/0227202, Aug. 14, 2014) (hereinafter Pilgaonkar).
The teachings of Hannapel, Schutt, Budde, Monk, Chasanoff, and Robinson are discussed above. Hannapel, Schutt, Budde, Monk, Chasanoff, and Robinson do not teach wherein the device comprises sodium bicarbonate.
However, Pilgaonkar discloses an oral care composition (abstract). The composition may comprise sodium bicarbonate as an antiseptic agent (¶ [0039]).
Schutt taught wherein the adhesive of orthodontic protection devices may comprise one or more actives. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated sodium bicarbonate into the adhesive of the orthodontic protection device of Hannapel since it is desirable in the art to have the adhesive comprise one or more actives as taught by Schutt and sodium bicarbonate is a known and effective actives as taught by Pilgaonkar.
In regard to instant claim 19 reciting an amount of sodium bicarbonate, since sodium bicarbonate is an antiseptic agent, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount through routine experimentation based on the level of microbe reduction desired. Where 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. See MPEP 2144.05(II)(A).
Response to Arguments
Applicant argues that the adhesive layer of Hannapel is not powder at any point. A solution that is applied wet and then dried leaves a film or bead residue on the surface, it does not yield a blend of discrete, free-flowing particulate powders mechanically engaged with that surface. Hannapel further requires that its adhesive beads include a plasticizer, and a glycerin-plasticized dried gel is neither anhydrous nor free-flowing.
The Examiner does not find Applicant’s argument to be persuasive. Hannapel discloses a plurality of beads that form an adhesive layer. A plurality of beads is a powder. It should be noted that claim 1 does not require the powder to be free-flowing, However, even if claim 1 were to recite free-flowing powders, Hannapel discloses in col. 7, lines 14-15 wherein the adhesive layer is dried until it is non-tacky. Thus, the beads of Hannapel are free-flowing since they are non-tacky. Additionally, a plasticizer is optional as disclosed in col. 9, lines 23-26 of Hannapel and from Hannapel disclosing a plasticizer in the dependent claims instead of the independent claim. As such, Applicant’s argument is unpersuasive.
Applicant argues that Schutt nowhere identifies a dental tubule blocking agent, a hypersensitivity desensitization ingredient, arginine, a salt of arginine, or arginine bicarbonate. A general statement that an adhesive may contain unspecified actives does not supply a reason to select the particular species recited in claim 1.
The Examiner does not find Applicant’s argument to be persuasive. As this is 103 obviousness rejection, no one piece of prior art is required to teach each and every claim limitation. As discussed in the rejection, Budde teaches wherein arginine, potassium nitrate, and calcium carbonate are actives. Combined with Schutt’s teaching that adhesives may comprise one or more actives, it would have been obvious to have incorporated arginine, potassium nitrate, and calcium carbonate into the adhesive of Hannapel. Applicant has not shown wherein the combination of actives claims is critical. Thus, it would have been obvious to one of ordinary skill in the art to select any known actives for incorporation. As such, Applicant’s argument is unpersuasive.
Applicant argues that one of ordinary skill following Schutt would have been discouraged from incorporating calcium carbonate into the adhesive layer of Hannapel, and would have had no reasonable expectation of success in doing so.
The Examiner does not find Applicant’s argument to be persuasive. Hannapel discloses in col. 7, lines 6-8 wherein the solvent is typically water, but another solvent such as alcohol could be employed. Thus, since Hannapel does not require water, one of ordinary skill in the art would not have been discouraged from incorporating calcium carbonate into the adhesive layer of Hannapel. As such, Applicant’s argument is unpersuasive.
Applicant argues that Hannapel lists xanthan gum among roughly thirty hygroscopic polymeric materials, and the preferred adhesive throughout both Hannapel and Schutt is polyvinylpyrrolidone.
The Examiner does not find Applicant’s argument to be persuasive. Choosing from a finite number of identified, predictable solutions support a conclusion of obvious. See MPEP 2143(I). Thus, selecting xanthan gum from a finite list is obvious. Also, a reference that “discloses a multitude of effective combinations does not render any particular formulation less obvious.” Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). Thus, Hannapel disclosing multiple hydratable hygroscopic polymeric materials does not make any one hydratable hygroscopic polymeric material (e.g., xanthan gum) less obvious. Additionally, a prior art reference is evaluated for all that it reasonably suggests and is not limited to any preferred embodiments. As such, Applicant’s argument is unpersuasive.
Applicant argues that the references are directed to different problems than the claimed composition.
The Examiner does not find Applicant’s argument to be persuasive. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See MPEP 2144(IV). Thus, it is not necessary for the references to be directed to the same problem as the claimed invention. As such, Applicant’s argument is unpersuasive.
Applicant argues that regarding claim 4, Budde supplies no concentration for potassium nitrate and the office action identifies no result-effective variable and no evidence that the claimed range would have been arrived at routinely in a dry, surface-engaged powder coating.
The Examiner does not find Applicant’s argument to be persuasive. As discussed in the rejection, it would have been obvious to one of ordinary skill in the art to have arrived at the claimed amount through routine experimentation based on the level of desensitizing desired. Such motivation does not require the prior art to supply a concentration. Because Budde teaches wherein potassium nitrate is a desensitizing agent. The amount of potassium nitrate is a result-effective variable since the amount would affect level of desensitization. The claimed range would have been arrived at routinely depending on the level of desensitization desired. Applicant has not shown wherein the claimed amount would not provide a desensitization effect. As such, Applicant’s argument is unpersuasive.
Applicant argues that regarding claim 9, Hannapel offers xanthan gum as one option among a long list of hydratable hygroscopic polymers, and both Hannapel and Schutt prefer polyvinylpyrrolidone. Budde does not address the identity of the polymeric adhesive at all.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above, choosing from a finite number of identified, predictable solutions support a conclusion of obvious. See MPEP 2143(I). Thus, selecting xanthan gum from a finite list is obvious. Also, a reference that “discloses a multitude of effective combinations does not render any particular formulation less obvious.” Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). Thus, Hannapel disclosing multiple hydratable hygroscopic polymeric materials does not make any one hydratable hygroscopic polymeric material (e.g., xanthan gum) less obvious. Additionally, a prior art reference is evaluated for all that it reasonably suggests and is not limited to any preferred embodiments. Furthermore, no one piece of prior art is required to teach each and every claim limitation. Thus, it is not necessary for Budde to address the identity of the polymeric adhesive. As such, Applicant’s argument is unpersuasive.
Applicant argues that nothing in Robinson suggests removing arginine bicarbonate from that aqueous, abrasive-containing dentifrice and incorporating it as a dry powder on a surface of a finger malleable base material that is pressed onto a tooth and left in place.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above, Hannapel discloses in col. 7, lines 6-8 wherein the solvent is typically water, but another solvent such as alcohol could be employed. Thus, since Hannapel does not require water, one of ordinary skill in the art would not have been discouraged from incorporating calcium carbonate into the adhesive layer of Hannapel. As such, Applicant’s argument is unpersuasive.
Applicant argues that regarding claim 3, establishing obviousness of that selection requires an articulated reason why one of ordinary skill would have chosen arginine bicarbonate and exclude arginine. The observation that any number of actives may be used supplies no such reason.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above, choosing from a finite number of identified, predictable solutions support a conclusion of obvious. See MPEP 2143(I). Thus, since arginine bicarbonate and arginine are known actives and it would have been obvious to have incorporated at only one active into an adhesive as taught by Schutt, it would have been obvious to have selected arginine bicarbonate over arginine. Applicant has not shown wherein arginine bicarbonate is advantageous over arginine. As such, Applicant’s argument is unpersuasive.
Applicant argues that regarding claim 10, no cited reference recognizes any of these concentrations as a result-effective variable in a dry, surface-engaged powder coating, and no cited reference discloses a requirement that the polymeric adhesive predominate by weight.
The Examiner does not find Applicant’s argument to be persuasive. The prior art does recognize the concentrations as result-effective variables. As discussed in the rejection, arginine and arginine bicarbonate are desensitizing agents and calcium carbonate is a remineralizing agent. Thus, the concentrations are result-effective since the concentration effects the level of desensitizing or remineralization present. Moreover, since xanthan gum allows the adhesive layer to be adhesive, it would have been obvious to one of ordinary skill in the art to have arrived at the claimed amount of xanthan gum based on the level of adhesion desired. The level of adhesion desired may cause xanthan gum to predominate. Thus, a predominate amount of xanthan gum would have been obvious. As such, Applicant’s argument is unpersuasive.
Applicant argues that the combination of xanthan gum and arginine bicarbonate in the claimed dry, powdered coating on a finger malleable dental base is not taught by either reference.
The Examiner does not find Applicant’s argument to be persuasive. As this is a 103 obviousness rejection, no one piece of prior art is required to teach each and every claim limitation. Thus, the combination of xanthan gum and arginine bicarbonate does not need to be taught in one reference. It would have been obvious to have made the combination since Hannapel discloses an adhesive layer comprising xanthan gum, it was known that adhesives may comprise one or more actives as taught by Schutt, and Robinson discloses sodium bicarbonate as an active. Applicant has not explained why this motivation is improper. As such, Applicant’s argument is unpersuasive.
Applicant argues that regarding claim 14, the claimed combination of dry, powdered materials mechanically engaged with and dispersed on the tooth-engaging surface is not the sprayed and dried aqueous adhesive layer of Hannapel.
The Examiner does not find Applicant’s argument to be persuasive. The teachings of Munk has been incorporated to provide motivation to have the adhesive layer of Hannapel mechanically engaged and dispersed on the finger malleable base material. As such, Applicant’s argument is unpersuasive.
Applicant argues that regarding claim 14, the claimed water-soluble polymer adhesive is not met by the inclusion of xanthan gum in a list of some thirty hygroscopic polymers preferring polyvinylpyrrolidone, and the dental tubule blocking agent or hypersensitivity desensitization ingredient is not identified in Hannapel or Schutt at all.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above. Selecting from a finite number of identified, predictable solutions is obvious, the prior art is not limited to preferred embodiments, and no one piece of prior art is required to teach each and every claim limitation. As such, Applicant’s argument is unpersuasive.
Applicant argues that regarding claim 14, the recesses shown in Hannapel are dimples formed by a dimpling tool to receive an orthodontic bracket, not channels that carry additional adhesive powder to the tooth-engaging surface.
The Examiner does not find Applicant’s argument to be persuasive. Hannapel discloses in col. 9, lines 6-7 wherein the dimple may be a channel or groove. As such, Applicant’s argument is unpersuasive.
Applicant argues that regarding claim 15, no cited reference teaches that the entire resulting dry blend is water soluble or water dispersible, and the adhesive beads of Hannapel necessarily include a plasticizer.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above, Hannapel does not require a plasticizer. Also, Hannapel does not require any water insoluble ingredients in the adhesive layer. As discussed above, since one may only incorporate arginine bicarbonate as the active into the adhesive layer comprising xanthan gum and arginine bicarbonate and xanthan gum are both entirely water-soluble, the claim limitation would have been obvious and Applicant’s argument is unpersuasive.
Applicant argues that regarding claim 16, neither Hannapel nor Schutt identifies arginine bicarbonate.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above, no one piece of prior art is required to teach each and every claim limitation. As such, Applicant’s argument is unpersuasive.
Applicant argues that regarding claim 20, the length of a device does not disclose or suggest a maximum number of grooves.
The Examiner does not find Applicant’s argument to be persuasive. Hannapel’s figures, for example Fig. 14A, 13, and 15, show wherein the grooves are evenly spaced apart through the entirety of the device. Therefore, since grooves are meant to be evenly spaced apart through the entirety of the device, it would have been obvious to one of ordinary skill in the art that the length of the device affects the maximum number of grooves. As such, Applicant’s argument is unpersuasive.
Applicant argues that the closed group of claim 20 has not been addressed.
The Examiner does not find Applicant’s argument to be persuasive. As discussed in the rejection, Hannapel discloses wherein the adhesive layer comprises xanthan gum and Schutt teaches wherein the adhesive of orthodontic protection devices may comprise one or more actives. Thus, one may incorporate arginine and calcium carbonate since they are actives. Thus, an adhesive layer consisting of xanthan gum, arginine, and calcium carbonate would have been obvious. As such, Applicant’s argument is unpersuasive.
Applicant argues that regarding claim 17, the calcium carbonate of Budde is a chemically different material.
The Examiner does not find Applicant’s argument to be persuasive. As discussed in the rejection, Budde does teach precipitated calcium carbonate. As such, Applicant’s argument is unpersuasive.
Applicant argues that regarding claim 19, one of ordinary skill reading Pilgaonkar would not have removed sodium bicarbonate from an effervescent acid-base couple and incorporated it at 0.1% to 5% into an anhydrous, acid-free dry powder coating with an expectation of obtaining a microbial benefit.
The Examiner does not find Applicant’s argument to be persuasive. Pilgaonkar discloses wherein sodium bicarbonate may be used as an antiseptic agent in addition to as a carbon dioxide source. It is not clear how sodium bicarbonate having use as a carbon dioxide source prevents it from being used as an antiseptic agent in another composition. Pilgaonkar does not teach wherein sodium bicarbonate would be unsuitable for the adhesive layer of Hannapel. As such, Applicant’s argument is unpersuasive.
Applicant argues that the amount of sodium bicarbonate is not a result-effective variable.
The Examiner does not find Applicant’s argument to be persuasive. Pilgaonkar discloses sodium bicarbonate as an antiseptic agent. Thus, the amount of sodium bicarbonate would affect antiseptic efficiency, thus being a result-effective variable. As such, Applicant’s argument is unpersuasive.
Conclusion
Claims 1-20 are rejected.
No claims are 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.
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/TRACY LIU/Primary Examiner, Art Unit 1614
