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 .
Status of Application
Applicants' arguments/remarks filed 06/29/2026 are acknowledged. Claims 2 and 12 are newly canceled. Claims 1, 3-5, 7, 13-14, 16-18 are currently amended. Claims 22-25 are newly added. Claims 1, 3-5, 7-9, 11, 13-14 and 16-25 are examined on the merits within and are currently pending.
Withdrawn Rejections
With applicants' amendment, filed 06/29/2026 and with respect to the applicant’s arguments/remarks: the 35 U.S.C. § 103 rejection of Claims 2 and 12 has been withdrawn in view of the cancelation of the claims.
Modified Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 24 fail to comply with the written description requirement because Claims 1 and 24 have limitation: “wherein the whitening pigment and opacifying agent component imparts an opaque and visually white appearance to the composition”, which is not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor. Applicant recites “the magnesium ion-containing material can be used as whitening pigment and thus is intended to impart whiteness to the oral care composition”, (0087), but does not recite visually; “from a consumer perspective there is a demand for white and opaque products”, (0003); or “the use of a magnesium ion containing material as opacifying agent and/or whitening pigment in oral care compositions is provided, (0009), but there is not “visually” in the claim. The introduction of a new modifier like "visually" is seen as introducing new matter or changing the scope of the claim in a way not supported by the original disclosure. For examining purpose, that limitation is changed to “wherein the whitening pigment and opacifying agent component imparts an opaque and white appearance to the composition,” the word “visually” is removed from Claims 1 and 24.
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 non-obviousness.
Claims 1, 3-5, 7-8, 11, 13-14, 16-19 and 21-25 are rejected under 35 U.S.C. 103 as being obvious over Schaeffer-Korbylo et al. (AU 2014233917 A1/WO 2014/151567 Al) in view of Chandrasekaran et al., (EP 2758025 B1) and further in view of Mitsuhashi et al. (CA 2476540).
Claims 1, 3, 22-23,
Schaeffer-Korbylo et al. teach oral care compositions. (Abs). The composition may also comprise one or more further agents: colorants and abrasive agents. (0058-0059). Colorants among those useful herein include pigments, dyes colorants are operable to provide a white or light-colored coating on a dental surface, to act as an indicator of locations on a dental surface that have been effectively contacted by the composition, and/or to modify appearance, in particular color and/or opacity, of the composition to enhance attractiveness to the consumer. Any orally acceptable colorant can be used, including FD&C dyes and pigments, magnesium carbonate. One or more colorants are optionally present in a total amount of about 0.001 wt% to about 20 wt. %. (0063). The abrasive agents include, but are not limited to calcium carbonate, (0064). When abrasives are present, the average particle size is generally about 0.1 to about 30 microns, for example about l to about 20 microns or about 5 to 15 microns. (0066). Oral care compositions (Title), containing fluoride ion source (0059). Representative fluoride ion sources include, but are not limited to: stannous fluoride, sodium fluoride, sodium monofluorophosphate. (0070). Colorants among those useful herein include pigments, dyes. In various embodiments, colorants are operable to provide a white or light-colored coating on a dental surface, to act as an indicator of locations on a dental surface that have been effectively contacted by the composition, and/or to modify appearance, in particular color and/or opacity, of the composition. Any orally acceptable colorant can be used, including magnesium carbonate. One or more colorants are optionally present in a total amount of about 0.001 wt. % to about 20 wt. %. (0063).
Schaeffer-Korbylo et al. do not teach magnesium carbonate particle size.
Chandrasekaran et al. teach toothpastes are generally of two types; opaque and transparent. Opaque toothpastes are generally white. They may also be colored. (0002). All toothpastes contain an abrasive. Gels usually contain silica, whereas opaque creams generally contain Calcium based abrasives, especially chalk. (0021). Usually, the particle size of chalk is from 1 to 60 microns, and preferred sizes range from 1 to 15 microns. (0023). Other abrasives may also be used depending upon the intended degree of abrasion. Other abrasive agents include magnesium carbonate. (0026). It would be obvious that magnesium carbonate with its physical properties, it can be both pigment and abrasive, and their particle sizes can be from 1 to 60 microns, and preferred sizes range from 1 to 15 microns.
Schaeffer-Korbylo et al. and Chandrasekaran et al. do not teach magnesium carbonate 4MgCO3·Mg(OH)2·4H2O.
Mitsuhashi et al. teach basic magnesium carbonate, production method and use of the same. (pg. 1, lines 3-4). Magnesium carbonate can be applied for dental and oral areas. (pg. 59, lines 13). The source of a basic magnesium carbonate that has been industrially utilized is represented by the chemical formula of mMgCO3·Mg(OH)2 ·nH2O. The value represented by m and n in this chemical formula varies depending on the condition of the production and thus is not constant. It is common that m is 3 to 5, and n is 3 to 8. (pg. 2, lines 1-7). With regard to the size of the tubular aggregated particle of a basic magnesium carbonate, the external diameter of 1 to 20 a mean particle diameter of 25 µm or less is more preferable. (pg. 46, lines 25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have an oral care composition comprising 0.001-20% magnesium carbonate as colorants/pigment, the composition comprising colorants agents, including pigments, dyes colorants to provide a white or light-colored composition, and/or to modify appearance, in particular color and/or opacity, of the composition taught by Schaeffer-Korbylo et al.; all opaque, transparent or generally white toothpastes containing an abrasive including magnesium carbonate, about l to about 20 microns or about 5 to 15 microns, taught by Chandrasekaran et al., where the source of magnesium carbonate can be 4MgCO3·Mg(OH)2 ·4H2O, and magnesium carbonate particle diameter of 1-20 µm, taught by Mitsuhashi et al. since they have shown that magnesium carbonate can be used in oral care with available source, since they all have taught magnesium carbonate and 4MgCO3·Mg(OH)2 ·4H2O can be used as colorants and abrasive to provide white or opaque composition and a claimed range falls entirely inside or overlaps a range disclosed in the prior art, a presumption of obviousness exists.
With regard to claim 4,
Schaeffer-Korbylo et al. and Chandrasekaran et al. teach magnesium carbonate while Mitsuhashi et al. teach hydromagnesite 4MgCO3·Mg(OH)2 ·4H2O and hydromagnesite has whiteness ≥ 92%.
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With regard to claims 5 and 16,
Mitsuhashi et al. teach evaluation of physical properties and the like of basic magnesium carbonate for the basic magnesium carbonate obtained in Examples and Comparative Examples, measurement of the specific surface area according to a BET method, and measurement of fine porosimetry according to a mercury intrusion method were performed. The BET specific surface area was measured with an automated specific area calculator Macsorb (HM model-1201) produced by Mountech Co., Ltd., (pg. 83, lines 20-26). The BET specific areas are from 24-196 m2/g. (Table 1, pg. 84).
With regard to claims 7 and 18,
Schaeffer-Korbylo et al. teach the oral care composition further comprises one or more agents
selected from an anti-plaque agent, a whitening agent, (0015, 0024, 0059), a tooth whitening
or tooth bleaching, (0073), colorants, which include pigments, dyes. In various embodiments, colorants are operable to provide a white or light-colored coating on a dental surface, to act as an indicator of locations on a dental surface that have been effectively contacted by the composition, and/or to modify appearance, in particular color and/or opacity, of the composition to enhance attractiveness to the consumer. Any orally acceptable colorant can be used, including FD&C dyes and pigments, talc, mica, magnesium carbonate, calcium carbonate, magnesium silicate, magnesium aluminum silicate, silica, and mixtures thereof. (0063).
With regard to claims 8 and 19,
Schaeffer-Korbylo et al. teach the oral care composition comprises an orally acceptable carrier for a toothpaste, a dental cream, a mouthwash, a chewing gum or a denture adhesive. (0016).
With regard to claim 11,
Schaeffer-Korbylo et al. teach the oral care composition further comprises one or more agents selected from an anti-plaque agent, a whitening agent, (0015, 0024, 0059), a tooth whitening or tooth bleaching, (0073). Colorants among those useful herein include pigments, dyes. In various embodiments, colorants are operable to provide a white or light-colored coating on a dental surface, to act as an indicator of locations on a dental surface that have been effectively contacted by the composition, and/or to modify appearance, in particular color and/or opacity, of the composition. Any orally acceptable colorant can be used, including magnesium carbonate. (0063).
With regard to claims 13-14,
Mitsuhashi et al. teach basic magnesium carbonate, production method and use of the same. (pg. 1, lines 3-4). Magnesium carbonate can be applied for dental and oral areas. (pg. 59, lines 13). The source of a basic magnesium carbonate that has been industrially utilized is represented by the chemical formula of mMgCO3·Mg(OH)2 ·nH2O. The value represented by m and n in this chemical formula varies depending on the condition of the production, and thus is not constant. It is common that m is 3 to 5, and n is 3 to 8. (pg. 2, lines 1-7). With regard to the size of the tubular aggregated particle of a basic magnesium carbonate, the external diameter of 1 to 20 a mean particle diameter of 25 µm or less is more preferable. (pg. 46, lines 25).
Mitsuhashi et al. teach for the basic magnesium carbonate obtained in Examples and Comparative Examples, measurement of the specific surface area according to a BET method, and measurement of fine porosimetry according to a mercury intrusion method were performed. The BET specific surface area was measured with an automated specific area calculator Macsorb (HM model-1201) produced by Mountech Co., Ltd., (pg. 83, lines 20-26). The BET specific areas are from 24-196 m2/g. (Table 1, pg. 84).
With regard to claim 17,
Schaeffer-Korbylo et al. teach oral care compositions (Title), containing fluoride ion source (0059). Representative fluoride ion sources include, but are not limited to: stannous fluoride, sodium fluoride, sodium monofluorophosphate. (0070). In certain embodiments the fluoride ion source includes stannous fluoride, sodium fluoride, amine fluorides, sodium monofluorophosphate, as 'Nell as mixtures thereof. In certain embodiments, the oral care composition of the invention may also contain a source of fluoride ions or fluorine-providing ingredient in amounts sufficient to supply about 50 to about 5000 ppm fluoride
ion, e.g., frorn about 100 to about 1000, from about 200 to about 500, or about 250 ppm
fluoride ion. Fluoride ion sources may be added to the compositions of the invention at a
level of about 0.001 wt.'% to about 10 wt. %, e.g., from about 0.003 wt.%; to about 5 wt.
%, 0.0l wt. % to about 1 wt.%, or about 0.05 wt. %. (0070). Based on the fluorine availability 200-500ppm fluoride ion available in about 0.01-1 wt. % fluoride ion in the composition, so fluoride ion availability could be 5-500%.
With regard to claim 21,
Mitsuhashi et al. teach impurities included in the basic magnesium carbonate obtained in Examples were carried out. The results are presented in Table 2, (pg. 84, lines 5-7), Na2O 0.04-0.46% and SO3 0.01-0.48% by weight of samples 1 and 5-9, or total of impurities of samples 1 and 5-9 are 0.06-0.94%. (pg. 85).
Claim 24,
Schaeffer-Korbylo et al. teach oral care compositions. (Abs). The composition may also comprise one or more further agents: colorants and abrasive agents. (0058-0059). Colorants among those useful herein include pigments, dyes colorants are operable to provide a white or light-colored coating on a dental surface, to act as an indicator of locations on a dental surface that have been effectively contacted by the composition, and/or to modify appearance, in particular color and/or opacity, of the composition to enhance attractiveness to the consumer. Any orally acceptable colorant can be used, including FD&C dyes and pigments, magnesium carbonate. One or more colorants are optionally present in a total amount of about 0.001 wt% to about 20 wt. %. (0063). The abrasive agents include, but are not limited to calcium carbonate, (0064). When abrasives are present, the average particle size is generally about 0.1 to about 30 microns, for example about l to about 20 microns or about 5 to 15 microns. (0066). Oral care compositions (Title), containing fluoride ion source (0059). Representative fluoride ion sources include, but are not limited to: stannous fluoride, sodium fluoride, sodium monofluorophosphate. (0070). Schaeffer-Korbylo et al. teach Colorants among those useful herein include pigments, dyes. In various embodiments, colorants are operable to provide a white or light-colored coating on a dental surface, to act as an indicator of locations on a dental surface that have been effectively contacted by the composition, and/or to modify appearance, in particular color and/or opacity, of the composition to enhance attractiveness to the consumer. Any orally acceptable colorant can be used, including magnesium carbonate. One or more colorants are optionally present in a total amount of about 0.001 wt. % to about 20 wt. %. (0063).
Schaeffer-Korbylo et al. teach oral care compositions (Title), containing fluoride ion source (0059). Representative fluoride ion sources include, but are not limited to: stannous fluoride, sodium fluoride, sodium monofluorophosphate. (0070). In certain embodiments the fluoride ion source includes stannous fluoride, sodium fluoride, amine fluorides, sodium monofluorophosphate, as 'Nell as mixtures thereof. In certain embodiments, the oral care composition of the invention may also contain a source of fluoride ions or fluorine-providing ingredient in amounts sufficient to supply about 50 to about 5000 ppm fluoride
ion, e.g., frorn about 100 to about 1000, from about 200 to about 500, or about 250 ppm
fluoride ion. Fluoride ion sources may be added to the compositions of the invention at a
level of about 0.001 wt.'% to about 10 wt. %, e.g., from about 0.003 wt.%; to about 5 wt.
%, 0.0l wt. % to about 1 wt.%, or about 0.05 wt. %. (0070). Based on the fluorine availability 200-500ppm fluoride ion available in about 0.01-1 wt. % fluoride ion in the composition, so fluoride ion availability could be 5-500%.
Schaeffer-Korbylo et al. do not teach magnesium carbonate particle size.
Chandrasekaran et al. teach toothpastes are generally of two types; opaque and transparent. Opaque toothpastes are generally white. They may also be colored. (0002). All toothpastes contain an abrasive. Gels usually contain silica, whereas opaque creams generally contain Calcium based abrasives, especially chalk. (0021). Usually, the particle size of chalk is from 1 to 60 microns, and preferred sizes range from 1 to 15 microns. (0023). Other abrasives may also be used depending upon the intended degree of abrasion. Other abrasive agents include magnesium carbonate. (0026). It would be obvious that magnesium carbonate with its physical properties, it can be both pigment and abrasive, and their particle sizes can be from 1 to 60 microns, and preferred sizes range from 1 to 15 microns.
Schaeffer-Korbylo et al. and Chandrasekaran et al. do not teach magnesium carbonate 4MgCO3·Mg(OH)2·4H2O.
Mitsuhashi et al. teach basic magnesium carbonate, production method and use of the same. (pg. 1, lines 3-4). Magnesium carbonate can be applied for dental and oral areas. (pg. 59, lines 13). The source of a basic magnesium carbonate that has been industrially utilized is represented by the chemical formula of mMgCO3·Mg(OH)2 ·nH2O. The value represented by m and n in this chemical formula varies depending on the condition of the production and thus is not constant. It is common that m is 3 to 5, and n is 3 to 8. (pg. 2, lines 1-7). With regard to the size of the tubular aggregated particle of a basic magnesium carbonate, the external diameter of 1 to 20 a mean particle diameter of 25 µm or less is more preferable. (pg. 46, lines 25).
Mitsuhashi et al. teach evaluation of physical properties and the like of basic magnesium carbonate for the basic magnesium carbonate obtained in Examples and Comparative Examples, measurement of the specific surface area according to a BET method, and measurement of fine porosimetry according to a mercury intrusion method were performed. The BET specific surface area was measured with an automated specific area calculator Macsorb (HM model-1201) produced by Mountech Co., Ltd., (pg. 83, lines 20-26). The BET specific areas are from 24-196 m2/g. (Table 1, pg. 84).
Schaeffer-Korbylo et al. and Chandrasekaran et al. while Mitsuhashi et al. teach hydromagnesite and hydromagnesite has whiteness ≥ 92%.
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have an oral care composition comprising 0.001-20% magnesium carbonate as colorants/pigment, the composition comprising colorants agents, including pigments, dyes colorants to provide a white or light-colored composition, and/or to modify appearance, in particular color and/or opacity, of the composition taught by Schaeffer-Korbylo et al.; all opaque, transparent or generally white toothpastes containing an abrasive including magnesium carbonate, about l to about 20 microns or about 5 to 15 microns, taught by Chandrasekaran et al., where the source of magnesium carbonate can be 4MgCO3·Mg(OH)2 ·4H2O, and magnesium carbonate particle diameter of 1-20 µm, taught by Mitsuhashi et al. since they have shown that magnesium carbonate can be used in oral care with available source, since they all have taught magnesium carbonate and 4MgCO3·Mg(OH)2 ·4H2O can be used as colorants and abrasive to provide white or opaque composition and a claimed range falls entirely inside or overlaps a range disclosed in the prior art, a presumption of obviousness exists.
With regard to claim 25,
Schaeffer-Korbylo et al. teach any orally acceptable colorant can be used, including FD&C dyes and pigments, talc, mica, magnesium carbonate, calcium carbonate, magnesium silicate, magnesium aluminum silicate, silica, titanium dioxide. (0063). And specific materials and compositions to be used are, accordingly, pharmaceutically- or cosmetically-acceptable, clinically effective, and/or clinically efficacious that is suitable for use with humans and or animals and is provided in an appropriate amount (a clinically efficacious amount) to provide the desired therapeutic, prophylactic, sensory, decorative, or cosmetic benefit without undue adverse side effects such as toxicity. (0084). Schaeffer-Korbylo et al. teach an option to have titanium dioxide in a list of acceptable excipients, which is generally considered within the skill of an ordinary artisan to include or omit any of those optional ingredients based on routine experimentation at an amount that causes no toxicity.
Claims 1, 9 and 20 are rejected under 35 U.S.C. 103 as being obvious over Schaeffer-Korbylo et al. (AU 2014233917 A1/WO 2014/151567 Al) in view of Chandrasekaran et al., (EP 2758025 B1) and further in view of Mitsuhashi et al. (CA 2476540 C), as applied in claim 1 above, and further in view of Budde et al., (WO 2015150011 A1).
The teachings of Schaeffer-Korbylo et al., Chandrasekaran et al. and Mitsuhashi et al. are described in claim 1 above.
Schaeffer-Korbylo et al. teach the pH range for orally acceptable, (0078), but not the exact numbers.
Chandrasekaran et al. teach The pH of preferred compositions is up to 10.5. Preferably, the pH is less than 9.5, (0069), but not clear of lower limit.
Budde et al. teach according to one embodiment of the present invention, the oral care composition has a pH between 7.5 and 10, or between 8 and 9. (pg. 27, lines 5-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have an oral care composition comprising 0.001-20% magnesium carbonate as colorants/pigment, taught by Schaeffer-Korbylo et al. and/or magnesium carbonate can be used as abrasive agents, about l to about 20 microns or about 5 to 15 microns, taught by Chandrasekaran et al., where the source of magnesium carbonate can be mMgCO3·Mg(OH) 2 ·nH2O, and magnesium carbonate particle diameter of 1-20 µm, taught by Mitsuhashi et al. and the pH range for the oral care composition is between 7.5 and 10, or between 8 and 9, taught by Budde, since they have shown that magnesium carbonate can be used in oral care with available source.
Response to Arguments
Rejection of Claims Under 35 U.S.C. §103:
Applicant argues that the cited references fail to teach or contemplate all of the limitations of independent claim 1, upon which the remaining rejected claims ultimately depend. Thus, the cited combination of Schaeffer-Korbylo in view of Chandrasekaran and Mitsuhashi fails to render the claimed subject matter obvious.
Applicant's arguments have been fully considered are not persuasive because the basis for 103 rejection is that no one reference has to teach all the claim limitations for an obviousness rejection and therefore several references are combined to render the claims obvious. One with ordinary skill in the art can learn from and select specific parts of several prior arts’ teachings before the effective filing date of the invention to achieve better outcome results even though some prior arts may teach more and may teach different things.
Applicant argues that the cited references do not disclose or suggest the claimed magnesium carbonate system; Specifically, Schaeffer-Korbylo, as the primary reference, fails to disclose, inter alia: magnesium carbonate particles limited to only magnesite and hydromagnesite, and
any disclosure of such materials in an amount of ≥1.83 wt.%, does not disclose or suggest
the use of magnesium carbonate materials as optical whitening pigments or opacifying
agents, with improved fluoride availability; does not disclose or suggest the specific combination of structural limitations and/or quantitative limitations recited in amended claim 1; magnesium carbonate disclosure is generic and non-specific and does not render the presently claimed subject matter obvious; fails to disclose the specific magnesium carbonate structures and concentration required by amended claim 1.
Applicant's arguments have been fully considered are not persuasive because Schaeffer-Korbylo does not need to teach all listed limitations of claim 1. A prima facie case of obviousness, according to MPEP 2144.05, where a claimed range falls entirely inside or overlaps a range disclosed in the prior art, a presumption of obviousness exists. Schaeffer-Korbylo teaches one magnesium carbonate structure, which is without water, and the anhydrous structure of magnesium carbonate is common knowledge. Colorants among those useful herein include pigments, dyes. In various embodiments, colorants are operable to provide a white or light-colored coating on a dental surface, to act as an indicator of locations on a dental surface that have been effectively contacted by the composition, and/or to modify appearance, in particular color and/or opacity, of the composition. Any orally acceptable colorant can be used, including magnesium carbonate. One or more colorants are optionally present in a total amount of about 0.001 wt. % to about 20 wt. %.
Applicant argues that Chandrasekaran is directed to toothpaste compositions comprising calcium-based abrasives. The reference discloses calcium carbonate-based formulations, and addresses issues of rheology and stability, not optical whitening or pigment replacement. Although Chandrasekaran generically and generally identifies magnesium carbonate as a possible abrasive (see 0026), it does not disclose magnesite or hydromagnesite, or a specific particle size for any magnesium carbonates. Thus, the Office Action's reliance on this reference fails to account for the specific structural limitations in the claims, in particular the structural limitations recited in amended claim 1.
Applicant's arguments have been fully considered are not persuasive because a toothpaste composition is also an oral care composition. Chandrasekaran may teach more, but Chandrasekaran also teaches abrasive agent magnesium carbonate, with particle size listed in the rejection of claim 1. Magnesium carbonate is a abrasive, but it also known as a white pigment and toothpaste also has opaque, transparent or white color. And for 103 rejection no one reference has to teach all limitation. Because Schaeffer-Korbylo teach Colorants among those useful herein include pigments, dyes. In various embodiments, colorants are operable to provide a white or light-colored coating on a dental surface, to act as an indicator of locations on a dental surface that have been effectively contacted by the composition, and/or to modify appearance, in particular color and/or opacity, of the composition. Any orally acceptable colorant can be used, including magnesium carbonate. One or more colorants are optionally present in a total amount of about 0.001 wt. % to about 20 wt. %.
Applicant argues that Mitsuhashi is concerned with chemical tooth whitening using bleaching agents and does not address optical whitening of the composition itself. And, Mitsuhashi only discloses basic magnesium carbonate, which is chemically distinct and does not correspond to magnesite or hydromagnesite, as recited in claim 1.
Applicant's arguments have been fully considered are not persuasive because for 103 rejection, no one reference has to teach all limitations. Schaeffer-Korbylo and Chandrasekaran teach magnesium carbonate, Schaeffer-Korbylo teaches tooth whitening and Mitsuhashi teach hydromagnesite (Mg5(C03)4(OH)2 • 4H2O), and one with skill in the art, is known for solving the same problem, is represented with design choices, may modify the teachings of the prior arts until they can achieve better outcome results so that they can have magnesium carbonate, hydromagnesite or a combination of both from Schaeffer-Korbylo et al., Chandrasekaran et al. and Mitsuhashi
Applicant argues that Table Whiteness for "all samples Ml-M6 are in the same range of 82-86 and none has whiteness CIELAB L * ot> 90 %", as recited in claim 4, is inaccurate. Applicant respectfully points out that Table 4 lists the whiteness for the oral care formulation, not the base magnesium carbonate component (which is what claim 4 recites as >90 % ).
Applicant's arguments have been fully considered are persuasive that Table 4 lists the whiteness for the oral care formulation, not the base magnesium carbonate component.
Applicant argues No Motivation/Improper Hindsight: there is no motivation, or rationale,
either in the references themselves or in the knowledge generally available to one of
ordinary skill in the art, to modify the reference or to combine reference teachings. There
also is no reasonable expectation of success. none of the cited references provide:
• a teaching or reasoning to select magnesium carbonate as both a whitening pigment
and opacifying agent, over other materials, that also improves fluoride availability
• a reason to select specific very specific types of magnesium carbonate (= magnesite and hydromagnesite), and the recited particle sizes
• a reason to exclude other magnesium compounds
In response to applicant's argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, as applicant recognizes that: Schaeffer-Korbylo discloses magnesium carbonate as one of many optional colorants; Chandrasekaran discloses magnesium carbonate as one of many abrasive options, and Mitsuhashi discloses basic magnesium carbonate materials by the chemical formula of mMgCO3·Mg(OH)2·nH2O and its particle size. However, regarding questions that i) a teaching or reasoning to select magnesium carbonate as both a whitening pigment and opacifying agent, over other materials: Schaeffer-Korbylo et al. teach Colorants among those useful herein include pigments, dyes. In various embodiments, colorants are operable to provide a white or light-colored coating on a dental surface, to act as an indicator of locations on a dental surface that have been effectively contacted by the composition, and/or to modify appearance, in particular color and/or opacity, of the composition. Any orally acceptable colorant can be used, including magnesium carbonate. (0063).
ii) a reason to select specific very specific types of magnesium carbonate (= magnesite and hydromagnesite), and the recited particle sizes; and iii) a reason to exclude other magnesium compounds, which are not the claims’limitations.
Applicant argues that although the Office Action asserts that Schaeffer-Korbylo provides a broad
range of 0.001-20 wt.% for colorants, Schaeffer-Korbylo does not disclose or emphasize a
concentration of "at least 1.83 wt.-%", and it does not associate concentration with pigment
effectiveness or opacity, and/or fluoride availability. Neither of the other two cited
references make this association either.
Applicant's arguments have been fully considered are not persuasive A prima facie case of obviousness, according to MPEP 2144.05, where a claimed range falls entirely inside or overlaps a range disclosed in the prior art, a presumption of obviousness exists. Schaeffer-Korbylo teaches one magnesium carbonate structure, which is without water, and the anhydrous structure of magnesium carbonate is common knowledge. Schaeffer-Korbylo et al. teach any orally acceptable colorant can be used, including FD&C dyes and pigments, talc, mica, magnesium carbonate, calcium carbonate, magnesium silicate, magnesium aluminum silicate, silica, titanium dioxide. (0063). And specific materials and compositions to be used are, accordingly, pharmaceutically- or cosmetically-acceptable, clinically effective, and/or clinically efficacious that is suitable for use with humans and or animals and is provided in an appropriate amount (a clinically efficacious amount) to provide the desired therapeutic, prophylactic, sensory, decorative, or cosmetic benefit without undue adverse side effects such as toxicity. (0084).
Applicant argues that the present claims require a "whitening pigment and opacifying agent"
component that comprises magnesium carbonate particles, i.e. anhydrous magnesium
carbonate (magnesite) and hydromagnesite, to impart both whitening and opacity, while
simultaneously improving fluoride availability. The prior art neither discloses nor suggests selecting these specific magnesium carbonates, nor providing the claimed optical properties
(e.g., BET surface area and high CIELAB L* values), while also achieving an improvement
in fluoride availability.
Applicant's arguments have been fully considered are not persuasive since Schaeffer-Korbylo et al. and Chandrasekaran et al. teach Magnesium carbonate and Mitsuhashi et al. teach hydromagnesite (Mg5(C03)4(0H)2 • 4H20),magnesium carbonate sources. Schaeffer-Korbylo et al. teach the oral care composition further comprises one or more agents selected from a whitening agent, (0015, 0024, 0059), a tooth whitening (0073) and Colorants among those useful herein include pigments, dyes. In various embodiments, colorants are operable to provide a white or light-colored coating on a dental surface, to act as an indicator of locations on a dental surface that have been effectively contacted by the composition, and/or to modify appearance, in particular color and/or opacity, of the composition. Any orally acceptable colorant can be used, including magnesium carbonate. Chandrasekaran et al. teach toothpastes are generally of two types; opaque and transparent. Toothpastes are oral care products. BET surface area and high CIELAB L* values and fluoride availability are listed in the rejections of claims above. Also, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant argues that the cited references do not teach or disclose these limitations or any reasoning for pursuing such a path. Instead, Chandrasekaran only teaches conventional calcium-based systems, not magnesium systems, and Mitsuhashi addresses only basic magnesium
carbonate (completely different structure). Accordingly, the proposed modification lacks a
rational underpinning.
Applicant's arguments have been fully considered are not persuasive since the claims are rejected according to their limitations above. Schaeffer-Korbylo et al. teach any orally acceptable colorant can be used, including FD&C dyes and pigments, magnesium carbonate. Chandrasekaran teaches other abrasive agents include magnesium carbonate. (0026). It would be obvious that magnesium carbonate with its physical properties can be both pigment and abrasive. Mitsuhashi et al. teach basic magnesium carbonate, production method and use of the same. (pg. 1, lines 3-4). Magnesium carbonate can be applied for dental and oral areas. (pg. 59, lines 13). The source of a basic magnesium carbonate that has been industrially utilized is represented by the chemical formula of mMgCO3·Mg(OH)2·nH2O. The value represented by m and n in this chemical formula varies depending on the condition of the production, and thus is not constant. It is common that m is 3 to 5, and n is 3 to 8. (pg. 2, lines 1-7). When m=4 and n=4, it is hydromagnesite Mg5(C03)4(0H)2 • 4H20.
Applicant argues that there is no motivation to substitute the calcium-based systems of
Chandrasekaran with the claimed magnesium carbonate materials, particularly in view of
the known differences in fluoride interaction and surface chemistry. Nor would a person of
ordinary skill in the art have had a reasonable expectation of success that such a substitution
would provide sufficient opacity and whiteness, while also improving fluoride availability.
Thus, Applicant submits the Office Action's rejection relies on impermissible hindsight
reconstruction.
Applicant's arguments have been fully considered are not persuasive since obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Please see details of rejections in the claims above.
Applicant argues that The Office Action rejects claims 9 and 20 the Office Action
relies on Buddeto cure these deficiencies of claim 1.
Applicant's arguments have been fully considered are not persuasive since there is no deficiencies explained above.
Conclusion
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 extension fee 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 date of this final action.
Correspondence
No claim is allowed.
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/NGOC-ANH THI NGUYEN/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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