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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/16/2025 has been entered.
Information Disclosure Statement
The IDS filed on 4/22/2022 has been considered. See the attached PTO 1449 form.
Status of Action/Claims
Receipt of Remarks/Amendments filed on 12/16/25 is acknowledged. Claims 1, 9, 11, 17, 22-23, 28, 40, 42, 52, 60 and 62-68 are currently pending in this application. Claims 40, 42 and 52 have been withdrawn. Accordingly, claims 1, 9, 11, 17, 22-23, 28, 60 and 62-68 are presented for examination on the merits for patentability.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Withdrawn Rejections/Objections
Applicant’s arguments with respect to the 103 rejections have been fully considered and are persuasive. The 103 rejections have been withdrawn because Weimer requires the filler particles having a refractive index (RI) of about 1.48 to 1.60 and display minimal light scattering. Incorporating Portland cement (RI of 1.70) into the composition of Weimer would not have been obvious as it falls outside the RI required by Weimer to display minimal light scattering.
New/Maintained Claim Objection(s) / Rejection(s)
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 9, 11, 17, 22-23, 28, 60 and 62-68 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12161523B2 in view of in view of Jin et al. (WO 02/078646 A1; Oct. 10, 2002) and Budd et al. (US 7090722B2; Aug. 15, 2006).
The ‘523 patent teaches a two part hardenable dental composition, wherein first part comprises an encapsulated material comprising a basic core material and an inorganic shell material comprising a metal oxide surrounding the core. The basic material comprises Portland cement and the metal oxide comprises titanium oxide and aluminum oxide. The composition also comprises a polymerizable material and acid-reactive filler. The second part comprises an acidic polymer and the shell is degradable by second part and the basic core material comprises a component having a pKa of 8-14. Further, ‘523 teaches the shell is a continuous film having an average thickness less than 500nm and the core having an average particle size of at least 5 micrometer (i.e., shell and core together are greater than 5 micrometer). The composition comprises a second filler of nanoscopic filler material wherein the second filler material comprises zirconia, silica or mixture thereof.
‘523 does not teach the composition further comprising a source of phosphorous ions or fluorine ions. However, these deficiencies are cured by Jin.
Jin throughout the reference teaches dental filler compositions which comprise bioactive particles of bioactive glass (Title, Abstract). It teaches bioactive particles of bioactive glass in the filler composition are characterized by their ability to firmly attach to living tissues, to promote tissue growth and to bond chemically with bone (Page 3, line 26 to Page 4, line 2). Table 10 of the reference discloses bioactive glass comprises CaO (calcium oxide) and P2O5 (phosphorous pentoxide) which reads on the source of phosphorous recited in instant claims.
The ‘523 teaches the composition comprising acid reactive filler. However, ‘523 does not teach the composition comprising fluoroaluminatesilicate glass as an acid-reactive filler. However, Budd cures this deficiency.
Budd throughout the reference teaches acid reactive dental filler compositions. Budd teaches that by incorporating acid reactive fillers, the dental composition can be prepared that exhibits improvements in one or more properties including, for example, strength, polish, polish retention, fluoride release, abrasion resistance, aesthetics, and radiopacity (summary of invention). Bud particularly teaches including fluoroaluminosilicate glass (FAS glass) (i.e., acid-reactive filler) which is suitable for use in oral environment, provide fluoride release and impart fluorescence and/or opalescence. (see: col. 16, line 62 to col. 17, line 4).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified ‘523 to incorporate the teachings of Jin and include the bioactive glass taught by Jin into the composition of ‘523. One would have been motivated to do so because similar to ‘523, Jin also teaches dental filler composition which are used, for example, as filling material in dentistry and Jin provides the motivation that bioactive particles of bioactive glass in the filler composition are characterized by their ability to firmly attach to living tissues, to promote tissue growth and to bond chemically with bone (Page 3, line 26 to Page 4, line 2). Thus, it would have been obvious to one skilled in the art to incorporate the bioactive glass taught by Jin into the composition of ‘523 because the benefits of bioactive glass disclosed by Jin would be strongly desired in dental works such as fillings.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified ‘523 to incorporate the teachings of Budd and include the acid-reactive filler and particularly FAS glass taught by Budd into the composition of 523. One would have been motivated to do so because Budd teaches that by incorporating acid reactive fillers, the dental composition can be prepared that exhibits improvements in one or more properties including, for example, strength, polish, polish retention, fluoride release, abrasion resistance, aesthetics, and radiopacity. Further, as discussed supra, Bud particularly teaches FAS glass is suitable for use in oral environment, provide fluoride release and impart fluorescence and/or opalescence. Thus, one skilled in the art would have been strongly motivated to include acid reactive fillers of Budd and particularly FAS glass into ‘523 dental composition.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 1, 9, 11, 17, 22-23, 28, 60 and 62-68 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12102499B2 in view of in view of Torabinejad et al. (US 5,415,547; May 16, 1995), Bringley et al. (US 2016/0222193 A1; Aug. 4, 2016) and Budd et al. (US 7090722B2; Aug. 15, 2006).
‘499 patent claims a two-part dental sealant composition comprising a first part comprising a (meth)acrylate resin and an oxidizing curing agent, a second part comprising a (meth)acrylate resin and a reducing curing agent, and an encapsulated material comprising a core comprising a basic material or a basic compound characterized by a pKa of 8-14, and a source of calcium ions derived from the basic material or the basic compound, a calcium compound other than the basic material or the basic compound, or a combination thereof; and a shell comprising a metal oxide, wherein the shell surrounds the core, and wherein the shell degrades, dissolves, or decomposes upon contact with water or an acidic component. The core further comprising a source of phosphorus ions, fluoride ions, or a combination thereof. The core comprising tricalcium silicate, dicalcium silicate, calcium silicate, tricalcium aluminate, tetracalcium aluminoferrite, or a combination thereof. The core further comprising magnesium oxide, calcium oxide, potassium sulfate, sodium sulfate, or a combination thereof. The core comprising a bioactive glass. The shell has a thickness of up to 500 nm. ‘499 also teaches a kit comprising the dental sealant.
‘499 does not teach the composition comprises Portland cement, the metal oxide being aluminum oxide, the size of core and shell combined, and the acid reactive filler recited in instant claims. Torabinejad, Bringley and Budd cure these deficiencies.
Torabinejad teaches tooth filling composition comprising Portland cement filler. Portland cement sets in the presence of moisture and blood, and is therefore easily applied and suitable for use in moist environments such as the mouth (abstract; summary of invention). One of the main component for Portland cement include silica (col. 7, line 15-35).
Bringley also teaches composite fillers for dental application. Bringley teaches the composite filler comprise inorganic particles having a diameter of 2-25 microns wherein the inorganic particles comprise silica and metal oxides such as aluminum and titanium (claims 1 and 2). Bringley teaches these particle size ranges are preferred in dentistry because they produce composites that have good mechanical properties while also having good wear/abrasion and gloss properties (para 0037).
Budd throughout the reference teaches acid reactive dental filler compositions. Budd teaches that by incorporating acid reactive fillers, the dental composition can be prepared that exhibits improvements in one or more properties including, for example, strength, polish, polish retention, fluoride release, abrasion resistance, aesthetics, and radiopacity (summary of invention). Bud particularly teaches including fluoroaluminosilicate glass (FAS glass) (i.e., acid-reactive filler) which is suitable for use in oral environment, provide fluoride release and impart fluorescence and/or opalescence. (see: col. 16, line 62 to col. 17, line 4).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified ‘499 to incorporate the teachings of Torabinejad and include Portland cement taught by Torabinejad into the composition of ‘499. One would have been motivated to do so because Torabinejad also teaches tooth filling composition which are used, for example, as filling material in dentistry and Torabinejad provides the motivation that Portland cement filler sets in the presence of moisture and blood, and is therefore easily applied and suitable for use in moist environments such as the mouth.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified ‘499 to incorporate the teachings of Bringley and formulate the particles in the size range taught by Bringley. One would have been motivated to do so because, as discussed supra, Bringley teaches the composite filler comprise inorganic particles having a diameter of 2-25 microns and these particle size ranges are preferred in dentistry because they produce composites that have good mechanical properties while also having good wear/abrasion and gloss properties (para 0037). Bringley also teaches the composite filler should provide increased transparency and aesthetic qualities that match natural enamel (para 0011 and 0025).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified ‘499 to incorporate the teachings of Bringley and include aluminum oxide as the metal oxide. As discussed supra, Bringley teaches the inorganic particles comprise silica and metal oxides such as aluminum and titanium. ‘499 also teaches metal oxides and it would have been obvious to one of ordinary skill in the art to try to substitute the known metal oxides used in composite filler compositions as a person with ordinary skill has good reason to pursue known options within his or her technical grasp. see MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified ‘499 to incorporate the teachings of Budd and include the acid-reactive filler and particularly FAS glass taught by Budd into the composition of ‘499. One would have been motivated to do so because Budd teaches that by incorporating acid reactive fillers, the dental composition can be prepared that exhibits improvements in one or more properties including, for example, strength, polish, polish retention, fluoride release, abrasion resistance, aesthetics, and radiopacity. Further, as discussed supra, Bud particularly teaches FAS glass is suitable for use in oral environment, provide fluoride release and impart fluorescence and/or opalescence. Thus, one skilled in the art would have been strongly motivated to include acid reactive fillers of Budd and particularly FAS glass into ‘499 dental composition.
With respect to instant claim 60, the recitation “the composition is a pulp capping composition” is an intended use of the claimed composition and does not add any structural limitation to the dental composition itself. The prior art teaching structurally the same composition, as instantly claimed, would necessarily be capable of this intended use limitation.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 1, 9, 11, 17, 22-23, 28, 60 and 62-68 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-26, 28-37, 41 of copending Application No. 18938820 (US20250064555A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because ‘820 also claims a dental composition comprising a core comprising Portland cement and a shell comprising metal oxides. ‘820 teaches all of the limitations recited in the instant claims except that ‘820 does not teach the acid reactive filler is fluoroaluminosilicate glass.
However, Budd cures this deficiency.
Budd throughout the reference teaches acid reactive dental filler compositions. Budd teaches that by incorporating acid reactive fillers, the dental composition can be prepared that exhibits improvements in one or more properties including, for example, strength, polish, polish retention, fluoride release, abrasion resistance, aesthetics, and radiopacity (summary of invention). Bud particularly teaches including fluoroaluminosilicate glass (FAS glass) (i.e., acid-reactive filler) which is suitable for use in oral environment, provide fluoride release and impart fluorescence and/or opalescence. (see: col. 16, line 62 to col. 17, line 4).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified ‘820 to incorporate the teachings of Budd and include the acid-reactive filler and particularly FAS glass taught by Budd into the composition of 820. One would have been motivated to do so because Budd teaches that by incorporating acid reactive fillers, the dental composition can be prepared that exhibits improvements in one or more properties including, for example, strength, polish, polish retention, fluoride release, abrasion resistance, aesthetics, and radiopacity. Further, as discussed supra, Bud particularly teaches FAS glass is suitable for use in oral environment, provide fluoride release and impart fluorescence and/or opalescence. Thus, one skilled in the art would have been strongly motivated to include acid reactive fillers of Budd and particularly FAS glass into ‘820 dental composition.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 9, 11, 17, 22-23, 28, 60 and 62-68 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24-39 of copending Application No. 18/820,899 (US20240423755A1) in view of Torabinejad et al. (US 5,415,547; May 16, 1995), Bringley et al. (US 2016/0222193 A1; Aug. 4, 2016) and Budd et al. (US 7090722B2; Aug. 15, 2006).
‘899 claims a two-part dental sealant composition comprising a first part comprising a (meth)acrylate resin and an oxidizing agent, a second part comprising a (meth)acrylate resin and a reducing curing agent, and an encapsulated material comprising a core comprising a basic material or a basic compound characterized by a pKa of 8-14, and a source of calcium ions derived from the basic material or the basic compound, a calcium compound other than the basic material or the basic compound, or a combination thereof; and a shell comprising a metal oxide, wherein the shell surrounds the core, and wherein the shell degrades, dissolves, or decomposes upon contact with water or an acidic component. The core further comprising a source of phosphorus ions, fluoride ions, or a combination thereof. The core comprising tricalcium silicate, dicalcium silicate, calcium silicate, tricalcium aluminate, tetracalcium aluminoferrite, or a combination thereof. The core further comprising magnesium oxide, calcium oxide, potassium sulfate, sodium sulfate, or a combination thereof. The core comprising a bioactive glass. The shell has a thickness of up to 500 nm. ‘899 also teaches a kit comprising the dental sealant. The metal oxide comprises titania, alumina, zirconia.
‘899 does not teach the composition comprises Portland cement and the size of core and shell combined. Torabinejad, Bringley cure these deficiencies.
Torabinejad teaches tooth filling composition comprising Portland cement filler. Portland cement sets in the presence of moisture and blood, and is therefore easily applied and suitable for use in moist environments such as the mouth (abstract; summary of invention). One of the main component for Portland cement include silica (col. 7, line 15-35).
Bringley also teaches composite fillers for dental application. Bringley teaches the composite filler comprise inorganic particles having a diameter of 2-25 microns wherein the inorganic particles comprise silica and metal oxides such as aluminum and titanium (claims 1 and 2). Bringley teaches these particle size ranges are preferred in dentistry because they produce composites that have good mechanical properties while also having good wear/abrasion and gloss properties (para 0037).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified ‘899 to incorporate the teachings of Torabinejad and include Portland cement taught by Torabinejad into the composition of ‘899. One would have been motivated to do so because Torabinejad also teaches tooth filling composition which are used, for example, as filling material in dentistry and Torabinejad provides the motivation that Portland cement filler sets in the presence of moisture and blood, and is therefore easily applied and suitable for use in moist environments such as the mouth.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified ‘899 to incorporate the teachings of Bringley and formulate the particles in the size range taught by Bringley. One would have been motivated to do so because, as discussed supra, Bringley teaches the composite filler comprise inorganic particles having a diameter of 2-25 microns and these particle size ranges are preferred in dentistry because they produce composites that have good mechanical properties while also having good wear/abrasion and gloss properties (para 0037). Bringley also teaches the composite filler should provide increased transparency and aesthetic qualities that match natural enamel (para 0011 and 0025).
With respect to instant claim 60, the recitation “the composition is a pulp capping composition” is an intended use of the claimed composition and does not add any structural limitation to the dental composition itself. The prior art teaching structurally the same composition, as instantly claimed, would necessarily be capable of this intended use limitation.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant requested the rejection be held in abeyance since the claims are subject to further amendment.
In response, since applicant have not provided any substantial arguments against the double patenting rejection, the double patenting rejection is maintained.
Conclusion
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/ALI S SAEED/ Examiner, Art Unit 1616