DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicants' arguments, filed September 18, 2025 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 Rejections - 35 USC § 103 - Obviousness
Maintained Rejection
1) Claims 1-22 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.
Response to Arguments
The Examiner submit that although Suleyman et al. disclose a smaller size, they do disclose 1 micron, which is close to the 2 microns of the instant claims. Therefore one of ordinary skill in the art would be motivated to use this size. One would reasonably conclude that the 1 micron size of Suleyman et al. would be suitable as opacifer. Further, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. One micron is close to 2 microns. Therefore it is reasonable to conclude that a 1 micron particle can perform the same function as a 2 micron particle. Therefore the instant claims are obvious over the combined references.
2) Claims 1-10 and 13-22 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.
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.
Response to Arguments
The Examiner submit that although Suleyman et al. disclose a smaller size, they do disclose 1 micron, which is close to the 2 microns of the instant claims. Therefore one of ordinary skill in the art would be motivated to use this size. One would reasonably conclude that the 1 micron size of Suleyman et al. would be suitable as opacifer. Further, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. One micron is close to 2 microns. Therefore it is reasonable to conclude that a 1 micron particle can perform the same function as a 2 micron particle. Therefore the instant claims are obvious over the combined references.
New Rejection
Claims 1-10 and 13-24 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.
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 1-24 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 1-22 are rejected.
No claims 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEZAH ROBERTS whose telephone number is (571)272-1071. The examiner can normally be reached Monday-Friday 11:00-7:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LEZAH ROBERTS/Primary Examiner, Art Unit 1612