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.
Claim Objections
Claim 1 is objected to because of the following informalities: reciting both “at least one” and “and a combination thereof” in the antepenultimate and penultimate lines, respectively, are redundant. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: the term “the” should be inserted immediately prior to “combination” in the first line. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the term “a” should be recited immediately prior to “combination of dry, powdered materials.”. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: the phrases “wherein the water-soluble polymeric adhesive consists of xanthan gum” and “xanthan gum is the only water-soluble polymeric adhesive” are redundant. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: “is in” in lines 2-4 should be recited as “in.” Appropriate correction is required.
Claim 18 is objected to because of the following informalities: reciting both “at least one” and “and a combination thereof” are redundant. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: reciting both “at least one” and “and a combination thereof” are redundant. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-20 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.
Claims 1, 6 and 14 recites a product consisting of one or more hydrocarbon-based waxes. The claims are indefinite since the scope of “product” is unclear. It is unclear whether a hydrocarbon-based wax in itself is considered a product or whether it must be within another composition in order to be considered as a product.
Claims 1, 6 and 14 recite the term “hydrocarbon-based.” The claims are indefinite since it is unclear how the term “based” modifies the definite term “hydrocarbon.” The claims also recite the term “hydrocarbon waxes” and it is unclear how the term “hydrocarbon-based” differs from “hydrocarbon.” To obviate this issue, the Examiner recommends deleting the term “based.”
Claims 1, 6 and 14 recite wherein the dry, powdered materials are engaged with one or more surfaces of the finger malleable base material. The claims are indefinite since the scope of the term “engaged” is unclear. It is unclear how the dry, powdered material has to interact with the surfaces of the finger malleable base material in order to be considered as being engaged with the surfaces.
Claim 4 depends from claim 2 and recites wherein the dry, powdered materials further comprises potassium nitrate. The claim is indefinite since it is unclear whether this potassium nitrate is further limiting the potassium nitrate of claim 2 or whether this is an additional potassium nitrate.
Regarding claim 14, the phrase "typically" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 19 recites “at least one in an amount of from about 0.1% to about 5% by weight. The claim is indefinite since it is unclear what component the claim is referencing.
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, 4-7, 9 and 12 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) and Budde et al. (US 2017/0105911, Apr. 20, 2017) (hereinafter Budde).
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). 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).
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 bicarbonate (i.e., dental tubule blocking agent or hypersensitivity desensitization ingredient) and calcium carbonate.
However, Budde discloses an oral composition comprising surface-reacted calcium carbonate for remineralization and/or whitening of teeth (abstract). 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, 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.
In regards 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 regards 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 regards 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).
2. Claims 3, 8, 10 and 11 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 further in view of Robinson et al. (US 2013/0224270, Aug. 29, 2013) (hereinafter Robinson).
The teachings of Hannapel, Schutt, and Budde are discussed above. Hannapel, Schutt, and Budde 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 regards 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 regards to instant claims 3 and 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 regards 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 regards 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 regards to instant claim 10 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.
3. Claims 13-18 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), and further in view of Stefan (US 6,100,314, Aug. 8, 2000).
The teachings of Hannapel, Schutt, and Budde are discussed above. Hannapel, Schutt, and Budde do not teach wherein the plurality of beads (i.e., dry, powdered materials) are free-flowing.
However, Stefan discloses wherein adhesive luting cements must be sufficiently free-flowing or rendered sufficiently free-flowing by suitable methods to be able to fill gaps in an optimum manner between restorative material and hard dental substances (col. 4, lines 56-62).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the plurality of beads of Hannapel to be free-flowing since the plurality of beads are adhesive and it is desirable in the art for adhesives that contact dental substances to be free-flowing as taught by Stefan.
In regards to instant claim 14 reciting wherein the dry, powdered materials have a particle size of a particulate powder, the plurality of beads are particulate powders and thus have a particle size of particulate powder.
In regards 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 arginine bicarbonate as the active into the adhesive layer comprising xanthan gum. Arginine bicarbonate and xanthan gum are both entirely water-soluble. Thus, the claim limitation would have been obvious.
In regards 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. 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), Stefan (US 6,100,314, Aug. 8, 2000), and further in view of Pilgaonkar et al. (US 2014/0227202, Aug. 14, 2014) (hereinafter Pilgaonkar).
The teachings of Hannapel, Schutt, Budde, and Stefan are discussed above. Hannapel, Schutt, Budde, and Stefan 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 regards 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).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,083,544, 11,980,675, 12,070,371, and 11,622,834 in view of Schutt et al. (US 10,391,040, Aug. 27, 2019) (hereinafter Schutt) and Budde et al. (US 2017/0105911, Apr. 20, 2017) (hereinafter Budde).
The pending claims differ from the patented claims insofar as reciting wherein the composition comprises arginine and calcium carbonate. 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). Budde discloses an oral composition comprising surface-reacted calcium carbonate for remineralization and/or whitening of teeth (abstract). The composition may comprise arginine as a desensitizing agent (¶ [0020]).
Schutt taught wherein compositions with an uncured (uncrosslinked) silicone HCR base may comprise one or more actives. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated arginine and calcium carbonate into the pending claim composition since it is desirable in the art to have compositions with an uncured (uncrosslinked) silicone HCR base comprise one or more actives as taught by Schutt and arginine and surface-reacted calcium carbonate are known and effective actives as taught by Budde.
Conclusion
Claims 1-20 are rejected.
No claims are allowed.
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/TRACY LIU/ Primary Examiner, Art Unit 1614
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