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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-7 and 18, as well as the species chlorhexidine, in the reply filed on 07/15/2026 is acknowledged. The traversal on pages 5-6 of the remarks is on the ground(s) that no serious burden of examination is required and the subject matter of the elected invention is sufficiently related that a search for the elected invention would encompass the non-elected group. This is not found persuasive because the argument does not address the specific reasoning set forth in the requirement for restriction as to why the inventions are distinct. Moreover, there is a search examination burden associated with method claims because the method invention requires a search and evaluation of novelty and obviousness for active steps whereas the composition invention requires a search for structural limitations. Finally, there is an examination burden as different factors affect compliance with 35 USC §§ 101 & 112(a) for the different categories of invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 8-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/15/2026.
Upon search, the examiner concludes that Applicant’s arguments traversing the species election are persuasive and the species election requirement is hereby withdrawn.
Claims 1-7 and 18 are under current examination.
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 2-5 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 2 recites “wherein the carrier material is used to carry fluoride ions, eugenol, menthol, or another pharmacon”. This phrase is indefinite because it is unclear whether the substances carried by the carrier material are required to be present or the language just indicates an intended purpose for the carrier material.
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 6 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schneider et al (US 20190201721; publication date: 07/04/2019).
With regard to claim 1, Schnieder discloses an oral care product (i.e. a dentifrice), in one embodiment, HABPs are prepared for formulation with ingredients of a suitable orally acceptable carrier, by diluting in buffer, e.g., a phosphate buffer such as Na2HPO4 buffer (1.5 mM) and CaCl.sub.2) (2.5 mM), to provide a buffered solution having approximately neutral or slightly basic pH, e.g., pH 7-8, e.g., about pH 7.5 (0006). With regard to claims 6 and 7, the composition is a toothpaste or mouthwash base (0008), which is necessarily suitable for application to teeth, bums, and interior surface of oral cavity.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-3, 6, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Budde et al (US 20170105911; publication date: 04/20/2017).
With regard to claims 1, 2, 6, and 7, Budde discloses a surface-reacted calcium carbonate (i.e. a carrier) for remineralization and whitening of teeth (title) that can be a toothpaste, a toothpowder, or a mouthwash (i.e. a dentifrice, which is necessarily suitable to be applied to teeth, gums, or an interior surface of an oral cavity; 0022). Budde teaches that the pH of the composition should fall within the range of 7.5 – 10 (claim 14). Budde does not teach one example where the pH is disclosed to be within the range recited in the instant claims; however, the range in pH disclosed by Budde overlaps with the range recited in the instant claims. See MPEP 2144.05 regarding overlapping ranges: “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
With regard to claim 2, Budde teaches associating the calcium carbonate with a pharmacon: According to another embodiment at least one active agent is associated with the surface-reacted calcium carbonate, preferably the active agent is at least one additional desensitizing agent, and more preferably the at least one additional desensitizing agent is selected from the group consisting of potassium nitrate, glutaraldehyde, silver nitrate, zinc chloride, strontium chloride hexahydrate, sodium fluoride, stannous fluoride, strontium chloride, strontium acetate, arginine, hydroxylapatite, calcium sodium phosphosilicate, potassium oxalate, calcium phosphate, calcium carbonate, bioactive glasses, and mixtures thereof (0020).
With regard to claim 3, Budde teaches that according to another embodiment the oral care composition further comprises an additional remineralisation and/or whitening agent, preferably selected from the group consisting of hydroxylapatite, e.g. nano-hydroxylapatite, calcium carbonate, e.g. amorphous calcium carbonate, and combinations thereof with casein phospholipids, hydrogen peroxide, carbamide peroxide, fluoride compounds, and mixtures thereof. Thus, Budde teaches combining the carrier materials (e.g. hydroxyapatite and calcium carbonate listed supra) with casein phospholipids, i.e. a phospholipid/phosphoprotein.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Budde et al (US 20170105911; publication date: 04/20/2017) as applied to claims 1-3, 6, and 7 above, and further in view of Tercinier et al (Journal of Colloid Science; 394(2013)458-466).
The relevant disclosure of Budde is set forth above. Budde discloses further including additional remineralization agents such as hydroxyapatite (a calcium phosphate and another “carrier material” according to the instant invention) but is silent with respect to coating this with casein.
Tercinier teaches absorption of caseins onto hydroxyapatite particles (abstract) and proposes that hydroxyapatite particles to which casein has been adsorbed to the surface (coated) may increase the stability of the HA particles (page 466, right col) and that milk proteins (casein) bind to tooth enamel (page 459, left col). Tercinier proposes that the particles may be useful in bone replacement (page 458, right col).
It would have been prima facie obvious to a person of ordinary skill in the art, e.g. an individual with a Ph.D. in biomaterials science, to add the casein-coated hydroxyapatite particles taught by Tercinier to Budde’s composition. The artisan of ordinary skill would have been motivated to do so in order to further increase the tooth remineralization capability of the composition and had reasonable expectation of success because Budde teaches adding further remineralization agents.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Budde et al (US 20170105911; publication date: 04/20/2017) as applied to claims 1-3, 6, and 7 above, and further in view of Kovtun (RSC Advances (2012)2, 870-875).
The relevant disclosure of Budde is set forth above. Budde discloses further including additional remineralization agents such as hydroxyapatite (a calcium phosphate and another “carrier material” according to the instant invention) but is silent with respect to chlorhexidine as the pharmacon present in the carrier.
Kovtun teach chlorhexidine-loaded calcium phosphate nanoparticles for dental maintenance treatment (title). Kovtun teaches further that growth of bacterial biofilms on tooth surfaces is a major problem in dentistry and that calcium phosphate particles functionalized with chlorhexidine both lead to remineralization and prevent colonization of bacteria (abstract).
It would have been prima facie obvious to add the chlorhexidine-loaded calcium phosphate nanoparticles taught by Kovtum to Budde’s composition. The artisan of ordinary skill would have been motivated to do so in order to further enhance the remineralization capability of the composition while also reducing bacteria colonization that can lead to carries and plaque. The artisan of ordinary skill would have had reasonable expectation of success because Budde teaches adding further remineralization agents.
Claims 1-4, 6, 7, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Sereda et al. (Journal of Functional Biomaterials 2023, 14, 42; publication date: 01/11/2023) in view of Budde et al (US 20170105911; publication date: 04/20/2017).
The applied reference has common inventors with the instant application. Based upon the earlier publication date of the reference, it constitutes prior art under 35 USC 102(a)(1), but falls within the grace period afforded the instant claims. Please refer to MPEP 717.01 for information regarding how a reference may be disqualified as prior art under 102(b)(1)(A) or (B).
Sereda discloses macro and nanoparticles that release eugenol and fluoride (title). The particles are formed from calcium carbonate, hydroxyapatite, mesoporous hydroxyapatite, etc. (pages 2-3) and are coated with casein (i.e. a phosphoprotein) and as noted above contain the pharmacons fluoride or eugenol. The particles are intended for dentifrices (abstract).
Sereda does not disclose the pH of the composition.
Budde teaches the pH suitable for dentifrice compositions comprising calcium carbonate and/or hydroxyapatite particles ranges from 7.5-10. It would have been prima facie obvious to formulate a dentifrice containing Sereda’s casein coated particles to have the pH disclosed by Budde because one having ordinary skill would have recognized this range as appropriate for like compositions used for the same purpose. See MPEP 2123(I)(A). The pH disclosed by Budde overlaps with the range recited in the instant claims. See MPEP 2144.05 regarding overlapping ranges: “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Sereda et al. (Journal of Functional Biomaterials 2023, 14, 42; publication date: 01/11/2023) in view of Budde et al (US 20170105911; publication date: 04/20/2017) as applied to claims 1-4, 6, 7, and 18 above, and further in view of Kovtun (RSC Advances (2012)2, 870-875).
The relevant disclosures of Sereda and Budde are set forth above. Budde discloses further including additional remineralization agents such as hydroxyapatite (a calcium phosphate and another “carrier material” according to the instant invention) but is silent with respect to chlorhexidine as the pharmacon present in the carrier.
Kovtun teach chlorhexidine-loaded calcium phosphate nanoparticles for dental maintenance treatment (title). Kovtun teaches further that growth of bacterial biofilms on tooth surfaces is a major problem in dentistry and that calcium phosphate particles functionalized with chlorhexidine both lead to remineralization and prevent colonization of bacteria (abstract).
It would have been prima facie obvious to add the chlorhexidine-loaded calcium phosphate nanoparticles taught by Kovtum to the Sereda/Budde composition. The artisan of ordinary skill would have been motivated to do so in order to further enhance the remineralization capability of the composition while also reducing bacteria colonization that can lead to carries and plaque. The artisan of ordinary skill would have had reasonable expectation of success because Budde teaches adding further remineralization agents.
With regard to claims 6 and 7, Budde teaches that the dentifrice can be a toothpaste, a toothpowder, or a mouthwash, which are necessarily suitable to be applied to teeth, gums, or an interior surface of an oral cavity (0022).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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, Ali Soroush can be reached at (571)272-9925. 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.
/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617
