DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/9/2026 has been entered.
Status of Application
Applicants' arguments/remarks filed 01/09/2026 are acknowledged. Claims 6 and 10 are newly canceled. Claims 1 is currently amended. Claims 1-5, 7-9, 11-14 and 16-21 are examined on the merits within and are currently pending.
Withdrawn Rejections
With applicants' amendment, filed 01/09/2026 and with respect to the applicant’s arguments/remarks: the 35 U.S.C. § 103 rejection of Claims 6 and 10 under 35 U.S.C. 103 has been withdrawn in view of the cancelation of the claims.
Modified Rejections
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, 11-14, 16-19 and 21 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).
Claims 1-3,
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. 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 sources.
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, 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. since they have shown that magnesium carbonate can be used in oral care with available source.
With regard to claims 5 and 16,
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 claims 7 and 18,
Schaeffer-Korbylo et al. teach the oral care composition further comprises 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 claims 11-12,
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. (0063).
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 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 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).
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:
A. Rejection of Claims 1-3, 5-8, 10-14, 16-19 and 21 as Being Obvious over Schaeffer-Korbylo in View of Chandrasekaran and Mitsuhashi
Applicant argues that independent claim 1 is amended and directed to an oral care composition that comprises a whitening pigment and opacifying component comprising magnesium carbonate. Accordingly, in view of at least the following reasons, it is respectfully submitted that the instant claims are not obvious over the cited art. Applicant respectfully submits that a prima facie case of obviousness has not been met for independent claim 1 as amended herein, at least because the cited references fail to teach or contemplate all of the limitations of independent claim 1, upon which the remaining rejected claims ultimately depend.
Applicant's arguments have been fully considered and are persuasive to overcome the previous obvious rejection but the current rejection is modified and they are not persuasive to overcome the current obvious rejection 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 respectfully disagrees with the allegation that it would have been obvious to the person of ordinary skill to combine the references as proposed by the Office Action:
Applicant argues that Schaeffer-Korbylo discloses that magnesium carbonate can be used as a colorant. See Schaeffer-Korby lo, paragraph [0063]. Regarding the inclusion of abrasives in its
composition, the reference teaches that abrasives may be present in an amount from "about 5
wt.% to about 15 wt.%," and discloses that calcium carbonate may be used as an abrasive.
See Schaeffer-Korbylo, paragraph [0064]. Notably, the reference does not include magnesium carbonate as a potential abrasive. Contrary to this relatively low amount of abrasive material disclosed in Schaeffer-Korbylo, Chandrasekaran discloses 30-60 wt.% of an abrasive, which may be magnesium carbonate. See, e.g., Chandrasekaran, claim 1. The reference does not contemplate a lower range for magnesium carbonate, or its calcium-based abrasives. As the ranges disclosed in the cited references are non-overlapping, with the lowest disclosed abrasive value of Chandrasekaran being double that of Schaeffer- Korbylo, the person of ordinary skill would not think to combine Schaeffer-Korbylo and Chandrasekaran as proposed by the Office Action. Applicant argues that Schaeffer-Korbylo only contemplates the inclusion of magnesium carbonate in its composition as a colorant, and therefore, the person of ordinary skill would not think to modify the reference with the magnesium carbonate abrasive, as taught by Chandrasekaran, in an amount double the maximum value which is taught by the reference (i.e., the abrasive upper limit taught by Schaeffer-Korbylo is 15 wt.%, as noted supra). Applicant also reiterates that independent claim 1 requires an oral care composition that comprises a whitening pigment and opacifying component comprising magnesium carbonate. In view of the above-noted incompatibilities between Schaeffer-Korby lo and Chandrasekaran, Applicant submits that at least this claim 1 limitation is distinct from and not taught by the proposed combination of references. Furthermore, Applicant notes that basic magnesium carbonate of Mitsuhashi is used
for encapsulating medical ingredients or other substances. See Mitsuhashi, p. 57, 11. 7-19.
However, it is neither used as whitening pigment nor opacifying agent. Thus, the person of
ordinary skill in the art would not look to the disclosure of Mitsuhashi to modify the oral care
composition of Schaeffer-Korbylo.
Applicant's arguments have been fully considered and are not persuasive according to previous office action of final rejection 10092025. 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. Also compound, for example MgCO3 has many inherent properties and can be used for many purposes. Magnesium carbonate can be used as a colorant, pigment, or dye, or can be used as an abrasive, even though it may not be listed in certain part or certain references, still it can be used listed as a colorant, pigment, or dye, in a total amount from 0.001 wt.%-20 wt.%. (0063), by Schaeffer-Korbylo, or it can be listed as abrasive to be used of 30-60 wt.% by Chandrasekaran. 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. In addition, applicant amends claim 1 currently An oral care composition comprising a whitening pigment and opacifying agent component, wherein the whitening pigment and opacifying agent component comprises a magnesium carbonate in an amount from 0.5 to 10 wt.-%, based on the total weight of the composition, matching Schaeffer-Korbylo’s teachings.
Applicant argues that Claims 2-3, 5-8, 10-14, 16-19 and 21 ultimately depend from claim 1, and are thus likewise believed to be non-obvious for the reasons discussed supra. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988) (If an independent claim is non-obvious under 35
U.S.C. § 103, then any claim depending therefrom is also non-obvious).
Applicant's arguments have been fully considered and are not persuasive as explained above. The obvious rejection is still stand for claim 1 so do for claims 2-3, 5-8, 10-14, 16-19 and 21.
Secondarv Considerations - Unexpected Technical Advantages of Present Disclosure
Applicant argues the unexpected advantageousness of the present disclosure over the prior art that the markedly high fluoride ion availability of the magnesium carbonate-containing oral care composition, particularly when compared to compositions comprising calcium carbonate. See, e.g., as-filed specification, paragraph [0088]. None of the cited references further teach or disclose the unexpected effect the present application of providing high fluoride availability while maintaining high whiteness and opacity.
Applicant's arguments have been fully considered and are not persuasive with unexpected data since Soriano et al. (Soriano et al., Influence of Chemical and Mineralogical Composition on
Color for Commercial Talcs. COLOR research and application. Vol. 27, N 6, Dec. 2002, pg. 430-440) teach L* whiteness for Talc-1-Talc-21, are in the range of 85-92. (Table III, CIELAB, pg. 435), in which Talc 8-Talc 21 have different percentages of Mg, measured by EDX microanalysis, expressed as counts per second (cps), and Mg cps varied from 12-254. (Table II, Results of EDX microanalysis, pg. 434)
B. Rejection of Claims 1 and 4 as Being Obvious over Schaeffer-Korbylo in View of Chandrasekaran, Mitsuhashi, and Pohl.
Applicant argues that The Office Action cites Pohl for allegedly teaching the magnesium carbonate precipitated calcium carbonate and fails to disclose a specific whiteness value for a
magnesium carbonate. Notably, as discussed supra, the data presented in the present
application highlight the distinct advantages of using a magnesium carbonate over
comparable calcium carbonate in oral care compositions.
Applicant's arguments have been fully considered and are persuasive since even though Pohl teaches the calcium source contains impurities magnesium carbonate, but Pohl teaches calcium carbonate whiteness of between 90-95%. However, claim 4 is dependent on claim 1 and since claim 1 is rejected so claim 4 is not cured to be rejected also, but not by prior art.
C. Rejection of Claims 1, 9, and 20 as Being Obvious over Schaeffer-Korbylo in
View of Chandrasekaran, Mitsuhashi, and Budde.
Applicant argues that Importantly, however, the person of ordinary skill in the art would not look to the disclosure of Budde to arrive at the present claims, which require an oral care composition
comprising magnesium carbonate. Budde does not disclose an oral composition comprising
a whitening pigment and/or opacifying agent that comprise magnesium carbonate, as required
by claim 1. Instead, Budde only discloses calcium carbonate teeth-whitening agents, which
may be derived from naturally occurring magnesium carbonate components (or impurities).
Importantly, the magnesium carbonate and magnesium ions disclosed in Budde are not part of
the final teeth-whitening agent composition. In fact, magnesium-ion containing materials are
only mentioned in Budde as either an impurity in the calcium carbonate and/or in connection
with the process for producing a surface-reacted calcium carbonate (SRCC). Budde explains
the source of its calcium carbonate in the following disclosure: The source of the calcium carbonate may comprise further naturally occurring components such as magnesium carbonate, alumino silicate etc.
Applicant's arguments have been fully considered and are not persuasive since magnesium carbonate and calcium carbonate have been recited together in many applications since they have very close characteristic and they often reside in same sources of minerals. One with skill in the art is surely can learn of information of calcium carbonate to work on magnesium carbonate. In this article, Budde clearly teaches calcium carbonate may comprise further naturally occurring components such as magnesium carbonate and does not specify magnesium carbonate as impurities, so even applicant points out in Budde’s article that a mineral material undergoes a
beneficiation step (such as a flotation, bleaching or magnetic separation step) to remove impurities, but magnesium carbonate is not impurities in Budde’s article. Also, Schaeffer-Korbylo et al. alone, teach the pH range for orally acceptable, is allowed for the range 6.5-7.5, which is overlapping with the applicant’s limitation. Chandrasekaran et al. teach the pH of preferred compositions is up to 10.5, preferably, the pH is less than 9.5, is also overlapping with applicant’s limitation. Budde’s teaching of pH 7.5-10 is not needed to reject claim 9 and 20, and is only additional.
Conclusion
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