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 to the Request for Continued Examination, filed April 14, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims
Claim Objections
Claim 26 is objected to because of the following informalities: there needs to be a space in between “of” and “2” in line 2 of the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 103 – Obviousness (Maintained Rejections)
1) Claims 1-2, 5-17, 19-22 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Vemishetti et al. (EP 3283046) in view of Suleyman et al. (TR 201308235).
Vemishetti et al. disclose oral care composition comprising a zinc ion source, a stannous ion source, polyphosphates and acid in a calcium pyrophosphate base. Stannous ion sources include stannous fluoride, stannous chloride and stannous sulfate (paragraph 0001). Acids include maleic and tartaric acid. Amino acids may also be used and include aspartic acid and glutamic acid. Polyphosphates used include sodium tripolyphosphate, tetrasodium pyrophosphate and tetrapotassium pyrophosphate (paragraph 0031). Zinc sources include zinc citrate, zinc lactate and zinc oxide (paragraph 0032). A toothpaste comprises calcium pyrophosphate, 0.454% stannous fluoride, 1% zinc oxide, tetrasodium pyrophosphate, sodium tripolyphosphate, glycerol, sodium saccharin, sodium lauryl sulfate and flavor (Table 1).
Vemishetti et al. differ from the instant claims insofar as it does not disclose boron nitride.
Suleyman et al. disclose a composition to prevent tooth decay, gingivitis, periodontitis and tooth sensitivity by preventing demineralization on the tooth surface. The composition comprises a mixture of nano-sized hexagonal boron nitride and fluoride ion and may be in the form of a tooth powder, toothpaste, dental floss, dental gel and mouth rinsing liquid (Abstract). Nano-sized hexagonal boron nitride is inert, does not dissolve or wet by any chemical, and has superior solid lubrication and anti-infection properties in tissues. Hexagonal boron nitride is used in various cosmetic products. Fluoride ion, on the other hand, has been proven to be effective in eliminating tooth decay and accelerating remineralization. Fluorides include sodium fluoride and stannous fluoride. The D50 of the boron is 1000 (1 micron). The boron and fluoride are mixed where 99% to 1% boron is added to 1% to 99% fluoride. One percent of the combination is added to a final oral care composition. When 1-99% boron is used, this would yield about 0.01 to 0.99% when in a toothpaste composition.
It would have been obvious to one of ordinary skill in the art prior to filing the application to have added boron nitride to the composition of Vemishetti et al. because boron nitride has superior solid lubrication and anti-infection to help prevent tooth decay, gingivitis and periodontitis.
In regards to claims 3-5, the compositions, the toothpaste composition of the combined references comprise boron nitride in an amount encompassed by the instant claims. Therefore, one of ordinary skill in the art would reasonably conclude that the toothpaste composition would have substantially the same whiteness value and amount of tin as that recited by the instant claims.
In regards to claims 8 and 11, the compositions, the toothpaste composition of the combined references comprise stannous fluoride in an amount encompassed by the instant claims. Therefore, one of ordinary skill in the art would reasonably conclude that the toothpaste composition would have substantially the same and amount of tin after 30 days as recited by the instant claims.
In regards to claim 25-26, the toothpaste composition of the combined teaching comprises boron nitride and therefore would be capable of providing the whiteness value of the instant claims for the recited amount of time.
Response to Arguments
The Examiner submits that in regards to the size of the boron, the indication that 1 micron is close to 2 microns is supported by MPEP 2144.05, which specifically discloses “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”. The size of 1 micron is close to that of 2 microns. Especially considering that Suleyman discloses a d50 of 1000 nm, which would encompass larger particles. Therefore 2 microns is obvious over 1 micron and an articulated reason has been provided. Further, it would not appear that boron nitride with a particle size of 1 micron would not be suitable as an opacifier and there appears to be no evidence to support that a smaller size boron nitride could not perform this function. In regards to the teaching away, the particle size of the boron has a D50 of 1000 nanometers. This indicates 50% of the particles of boron nitride are larger than 1000 nanometers, which would also encompass particles sizes close to 2000 nanometers. Therefore, Suleyman et al., does not necessarily teach away from 2 microns an makes the instant claims obvious.
2) Claims 1-2, 5-22 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Porter et al. (WO 2011/123123) in view of Suleyman et al. (TR 201308235).
Porter et al. disclose oral care compositions such as dentifrice compositions, comprising an orally acceptable vehicle, metal oxide particles having an average particle size of no greater than a dentin tubule and at least one amino acid capable of chelating the metal oxide. The metal oxide particles have a median particle size of 5 microns or less, and may comprise zinc oxide (Abstract). Amino acids used include glycine and arginine (paragraph 00019-00021). The dentifrice compositions include toothpaste (paragraph 00029). Oral care agent that may be added and include stannous ions, honokiol, peroxide propolis and ursic acid (paragraph 00033). Suitable abrasives include calcium pyrophosphate, calcium carbonate and silica (paragraph 00062). Anticalculus agents may be added and include sodium tripolyphosphate and tetrasodium pyrophosphate (paragraph 00086). A saliva stimulating agent useful is used for the amelioration of dry mouth. Any orally acceptable saliva stimulating agent can be used, including without limitation food acids such as citric, lactic, malic, succinic, ascorbic, adipic, fumaric and tartaric acids, and mixtures thereof (paragraph 00088). An example of a dentifrice comprises sorbitol, water, silica, zinc oxide, arginine and 0.243% sodium fluoride (Table 1).
Porter et al. differ from the instant claims insofar as it does not disclose boron nitride.
Suleyman et al. disclose a composition to prevent tooth decay, gingivitis, periodontitis and tooth sensitivity by preventing demineralization on the tooth surface. The composition comprises a mixture of nano-sized hexagonal boron nitride and fluoride ion and may be in the form of a tooth powder, toothpaste, dental floss, dental gel and mouth rinsing liquid (Abstract). Nano-sized hexagonal boron nitride is inert, does not dissolve or wet by any chemical, and has superior solid lubrication and anti-infection properties in tissues. Hexagonal boron nitride is used in various cosmetic products. Fluoride ion, on the other hand, has been proven to be effective in eliminating tooth decay and accelerating remineralization. Fluorides include sodium fluoride and stannous fluoride. The D50 of the boron is 1000 (1 micron). The boron and fluoride are mixed where 99% to 1% boron is added to 1% to 99% fluoride. One percent of the combination is added to a final oral care composition. When 1-99% boron is used, this would yield about 0.01 to 0.99% when in a toothpaste composition.
It would have been obvious to one of ordinary skill in the art prior to filing the application to have added boron nitride to the composition of Porter et al. because boron nitride has superior solid lubrication and anti-infection to help prevent tooth decay, gingivitis and periodontitis.
It would have been obvious to one of ordinary skill in the art prior to filing the application to have used stannous fluoride as the stannous ions of Porter et al., because they are suitable stannous providing compounds.
In regards to claims 3-5, the compositions, the toothpaste composition of the combined references comprise boron nitride in an amount encompassed by the instant claims. Therefore, one of ordinary skill in the art would reasonably conclude that the toothpaste composition would have substantially the same whiteness value and amount of tin as that recited by the instant claims.
In regards to claims 8 and 11, the compositions, the toothpaste composition of the combined references comprise stannous fluoride in an amount encompassed by the instant claims. Therefore, one of ordinary skill in the art would reasonably conclude that the toothpaste composition would have substantially the same and amount of tin after 30 days as recited by the instant claims.
In regards to claim 25-26, the toothpaste composition of the combined teaching comprises boron nitride and therefore would be capable of providing the whiteness value of the instant claims for the recited amount of time.
Response to Arguments
The Examiner submits that in regards to the size of the boron, the indication that 1 micron is close to 2 microns is supported by MPEP 2144.05, which specifically discloses “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”. The size of 1 micron is close to that of 2 microns. Especially considering that Suleyman discloses a d50 of 1000 nm, which would encompass larger particles. Therefore 2 microns is obvious over 1 micron and an articulated reason has been provided. Further, it would not appear that boron nitride with a particle size of 1 micron would not be suitable as an opacifier and there appears to be no evidence to support that a smaller size boron nitride could not perform this function. In regards to the teaching away, the particle size of the boron has a D50 of 1000 nanometers. This indicates 50% of the particles of boron nitride are larger than 1000 nanometers, which would also encompass particles sizes close to 2000 nanometers. Therefore, Suleyman et al., does not necessarily teach away from 2 microns an makes the instant claims obvious.
3) Claims 1-2, 5-12, 22 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Suleyman et al. (TR 201308235).
Suleyman et al. disclose a composition to prevent tooth decay, gingivitis, periodontitis and tooth sensitivity by preventing demineralization on the tooth surface. The composition comprises a mixture of nano-sized hexagonal boron nitride and fluoride ion and may be in the form of a tooth powder, toothpaste, dental floss, dental gel and mouth rinsing liquid (Abstract). Nano-sized hexagonal boron nitride is inert, does not dissolve or wet by any chemical, and has superior solid lubrication and anti-infection properties in tissues. Hexagonal boron nitride is used in various cosmetic products. Fluoride ion, on the other hand, has been proven to be effective in eliminating tooth decay and accelerating remineralization. Fluorides include sodium fluoride and stannous fluoride. The D50 of the boron is 1000 (1 micron). The boron and fluoride are mixed where 99% to 1% boron is added to 1% to 99% fluoride. One percent of the combination is added to a final oral care composition. When 1-99% boron is used, this would yield about 0.01 to 0.99% when in a toothpaste composition.
A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. The size boron of the Suleyman et al., 1 micron, is close to that of the instant claims, 2 microns. Therefore, the amount recited by the instant claims is obvious over Suleyman et al.
In regards to claims 3-5, the compositions, the toothpaste composition comprise boron nitride in an amount encompassed by the instant claims. Therefore the toothpaste composition would have substantially the same whiteness value and amount of tin as that recited by the instant claims.
In regards to claims 8 and 11, the compositions, the toothpaste composition comprise stannous fluoride in an amount encompassed by the instant claims. Therefore the toothpaste composition would have substantially the same and amount of tin after 30 days as recited by the instant claims.
In regards to claim 25-26, the toothpaste composition of the combined teaching comprises boron nitride and therefore would be capable of providing the whiteness value of the instant claims for the recited amount of time.
Response to Arguments
The Examiner submits that in regards to the size of the boron, the indication that 1 micron is close to 2 microns is supported by MPEP 2144.05, which specifically discloses “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”. The size of 1 micron is close to that of 2 microns. Especially considering that Suleyman discloses a d50 of 1000 nm, which would encompass larger particles. Therefore 2 microns is obvious over 1 micron and an articulated reason has been provided. Further, it would not appear that boron nitride with a particle size of 1 micron would not be suitable as an opacifier and there appears to be no evidence to support that a smaller size boron nitride could not perform this function. In regards to the teaching away, the particle size of the boron has a D50 of 1000 nanometers. This indicates 50% of the particles of boron nitride are larger than 1000 nanometers, which would also encompass particles sizes close to 2000 nanometers. Therefore, Suleyman et al., does not necessarily teach away from 2 microns an makes the instant claims obvious.
Obvious-Type 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 1-2, 5-22 and 25-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-24 of copending Application No. 18/317,987 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive insofar as they are both toothpaste compositions with an oral carrier. The instant claims differ from the copending claims insofar as the independent claim recites boron nitride and recite calcium pyrophosphate in the dependent claim, whereas the copending claims recite calcium pyrophosphate in the independent claims and boron nitride in the dependent claim. Therefore the instant claims are obvious over the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants respectfully defer these issues until the application is otherwise in condition for allowance. Since this has not occurred, the rejection is maintained.
Conclusion
Claims 1-2, 5-22 and 25-26 are rejected.
No claims allowed.
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/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
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