DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Status Summary
Claims 1, 3-7, and 12-14 are currently pending. Claim 1 is amended to add functional language and to limit the composition to a mouthrinse or dentifrice. Therefore, Claims 1-7, 10, and 12-14 are under examination.
Withdrawn Rejections
Claims 1 and 10 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. The text that triggered the rejection has been deleted. Therefore, the rejection is withdrawn.
Claims 2 and 10 were rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form. The text that triggered the rejection has been deleted. Therefore, the rejection is withdrawn.
Claim Rejections - 35 USC § 112
New rejection - Necessitated by amendment
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 1, 3-7, and 12-14 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 1 recites the limitation "the oral care composition" in line 2. There is insufficient antecedent basis for this limitation in the claim. A person of ordinary skill in the art (POSA) is not provided the information of what constitutes the oral care agent: the toothpaste can be the complete oral care composition or a part of the oral care composition. Therefore, a POSA would not understand the full components of the oral care composition.
The dependent claims reference back to “the oral care composition” of a previous claim but the POSA is not apprised of the components of the composition. The claims are indefinite because the POSA is not apprised of the metes and bounds of the claimed invention.
Claim Objections
Claim 1 is objected to because of the following informalities: the second recitation of part “(f)” should be changed to “(g)”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
Rejection maintained, slightly modified due to amendment
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 3-7 and 12-14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Natsch (US PG-PUB 2008/0247966) in view of Swaine et al. (US PG-PUB 2008/0008729).
Claimed invention
Claim 1 is drawn to a toothpaste composition comprising:
(a) from about 0.01% to about 5.0% of an antibacterial agent (specifically stannous ion source, a zinc ion source, cetylpyridinium chloride, or combinations thereof) by weight of the oral care composition;
(b) from about 0.01% to about 0.2% of 4-methoxybenzaldehdye (anisaldehyde) by weight of the oral care composition;
(c) about 1.5-15% disodium pyrophosphate, wherein no more than about 20% of the disodium pyrophosphate is dissolved in the oral care composition;
(d) 10% to 50% of an abrasive comprising hydrated silica;
(e) 0.025% to 9% of sodium lauryl sulfate;
(f) 2% to 10% of a thickening agent comprising carboxymethylcellulose; and
(g) an orally-acceptable carrier.
Prior Art
Natsch teaches oral care compositions (e.g., toothpaste, mouthrinse – see Claim 6, 0031) for counteracting oral malodor. See title; abstract. An example composition is disclosed as Example 6d:
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. See par. 0055. Example 6d of Natsch specifically exemplifies a mouth spray comprising 1% of an oral malodor counteracting (“OMC”) flavor composition – namely OMC Flavour A according to example 4 – wherein said OMC flavor composition contains 5% anisaldehyde.
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. See par. 0044.
Therefore, the mouth spray ultimately contains 0.05% anisaldehyde. Thus, part (b) is met. The composition also comprises deionized water, a flavoring system, and 4% Cremophor surfactant, which are all carriers. Thus, (g) is met. Although the mouth spray contains 0.2% eugenol as an antimicrobial agent (See par. 0022; claim 3), Natsch teaches the classical approach to reduce oral malodor is to combat malodor-causing bacteria by using one or more classical antibacterial agents such as triclosan, cetylpyridinium chloride, chlorhexidine. See par. 0004. Natsch teaches compositions can further contain known oral care ingredients: hydrated silica (i.e., part (d)) and sodium lauryl sulfate (SLS) (i.e., part (e)) and carboxymethylcellulose (CMC) Blanose 7MFD (i.e., part (f)). See par. 0049,0051.
Although Natsch teaches the treatment of oral malodor using oral care products containing the claimed concentration of OMC flavor actives such as anisaldehyde and 0.2% of known antibacterial agent such as eugenol and cetylpyridinium chloride and chlorhexidine and further contain known oral care ingredients: hydrated silica and sodium lauryl sulfate (SLS) and carboxymethylcellulose (CMC) Blanose 7MFD and carriers and may be formulated as toothpaste and/or mouthwash, Natsch does not expressly exemplify the oral care products comprising: 1) the specific claimed combination of cetylpyridinium chloride, 2) hydrated silica, SLS and CMC and 4)disodium pyrophosphate, wherein no more than about 20% of the disodium pyrophosphate is dissolved in the oral care composition in combination with the anisaldehyde and carrier.
Regarding the specific claimed antibacterial agent (e.g., cetylpyridinium chloride), however, one of ordinary skill in the art would have found it obvious to incorporate an antibacterial agent such as cetylpyridinium chloride because Natsch teaches the classical approach to reduce oral malodor is to combat malodor-causing bacteria by using one or more classical antibacterial agents such as cetyl-pyridinium chloride, chlorhexidine, or triclosan. See Natsch, par. 0004. Thus, one of ordinary skill in the art would have recognized that one or more classical antibacterial agent (e.g., triclosan, cetylpyridinium chloride, chlorhexidine) would have been suitable in place of 0.2% eugenol at similar concentration of eugenol. The artisan would have reasonably believed that the cetylpyridinium chloride would provide its antibacterial activity in order to reduce malodor causing bacteria. Further given that other known oral care ingredients are disclosed for the compositions including SLS, hydrated silica and CMC, the artisan would have reasonable believed these ingredients may be successfully added to an oral care composition.
Regarding about 1.5-15% tetrasodium pyrophosphate, wherein no more than about 20% of the tetrasodium pyrophosphate is dissolved in the oral care composition, however, it was already known that polyphosphates including pyrophosphate agents are used in oral care compositions as antitartar ingredients to help retard calculus formation. For example, Swaine teaches pyrophosphate, tripolyphosphate and hexametaphosphate are used in oral care compositions to impart antitartar efficacies. See 0004. Swaine teaches predominately undissolved pyrophosphate (i.e., no more than about 20% of the total pyrophosphate salt dissolved in the composition) is added to oral care compositions as anticalculus agents. See 0071,0073. Tetrasodium pyrophosphate is the preferred pyrophosphate used in the oral care composition. See 0073. The amount of pyrophosphate salt useful in making these compositions is any tartar control effective amount, generally from about 1.5% to about 15%, preferably from about 2% to about 10%, and most preferably from about 3% to about 8%, by weight of the dentifrice composition. See 0073. One of ordinary skill in the art would have found it obvious to incorporate polyphosphate and/or about 1.5% to about 15% pyrophosphate anticalculus agents such as tetrasodium pyrophosphate into the oral care formulation because about 1.5% to about 15% pyrophosphates and other polyphosphates are added to oral care compositions to help retard calculus formation, wherein tetrasodium pyrophosphate is the preferred pyrophosphate. The artisan would have incorporated a pyrophosphate (e.g., tetrasodium pyrophosphate) and/or a polyphosphate as an anticalculus agent because a POSA would have reasonably believed that the OMC flavor compositions containing a polyphosphate and/or a pyrophosphate anticalculus agent can be suitably used in the oral care formulations in order to reduce malodor and further reduce calculus formation.
Regarding the functional limitation “wherein the antibacterial agent, the anisaldehyde, the tetrasodium phosphate and the carrier are compatible and do not reduce the composition's stability or efficacy”, it does not impart patentable distinction. Natsch recognizes drawbacks of prior oral care compositions such as degradation requiring high amounts of active that lead to inefficiency and impracticality. See 0009. Natsch explicitly teaches the oral compositions as end-user products sustaining activity/efficacy. See 0048. Thus, Natsch already suggests stability. Furthermore, a POSA developing an oral care composition comprising an antibacterial, flavor aldehyde such as anisaldehyde, and a tetrasodium pyrophosphate would reasonably aim to produce a stable, effective product that maintains its activity and stability over shelf-life. Achieving compatibility and stability would have been a reasonably desired outcome of standard formulation practice to produce a product useful for its intended purpose for the end-user. Accordingly, ensuring that the components in the oral composition coexist without reducing stability or efficacy represents the predictable application of compounding.
Therefore, the claimed invention as a whole would have been prima facie obvious at the time of the invention.
Claim 12-14
Claim 12 limits claim 1, wherein the orally acceptable carrier comprises water. Claim 13 limits claim 1, wherein the orally acceptable carrier comprises a humectant. Claim 14 limits claim 13, wherein the humectant comprises glycerin, sorbitol, xylitol, butylene glycol, polyethylene glycol, propylene glycol, trimethyl glycine, or combinations thereof. Example 6d of Natsch is a mouthspray comprising water and glycerol, i.e., glycerin.
Claims 3 and 7:
Natsch does not expressly teach stannous chloride (Claims 3 and 7) or sodium fluoride (Claim 7)
Claim 3 limits claim 1, wherein the stannous ion source comprises stannous fluoride, stannous chloride, stannous pyrophosphate, or combinations thereof. Claim 7 limits claim 5, wherein the oral care composition comprises sodium fluoride and stannous chloride.
However, both stannous chloride or sodium fluoride were already known for use in oral care compositions to impart beneficial effects. For example, Swaine teaches that it is well-known that oral care products can provide both therapeutic and cosmetic hygiene benefits to consumers. Therapeutic benefits include caries prevention which is typically delivered through the use of various fluoride salts and gingivitis prevention by the use of an antimicrobial agent such as triclosan, stannous fluoride. Swaine teaches flavor formulations benefit from agents that have chemical reducing capability, in particular stannous ions is a preferred active in oral care compositions because of its wide range of benefits and phenolics and derivatives derived from plant sources with useful antimicrobial, anti-inflammatory and antioxidant activities. See 0041. Preferred stannous ion sources include stannous fluoride and stannous chloride dihydrate. See 0043. One of ordinary skill in the art would have found it obvious to incorporate stannous ions such as stannous fluoride and stannous chloride dihydrate in order to impart its beneficial effects to the oral cavity including antimicrobial, anti-inflammatory and antioxidant activities.
Swaine further teaches that fluoride ion can be used in mouthwashes and mouth sprays as an anticaries agent. See 0052. A wide variety of fluoride ion-yielding materials can be employed as sources of soluble fluoride in the present compositions. Representative fluoride ion sources include: stannous fluoride, sodium fluoride, potassium fluoride, sodium monofluorophosphate, indium fluoride and many others. Stannous fluoride and sodium fluoride are preferred. See 0066. One of ordinary skill in the art would have found it obvious to further incorporate stannous ions such as stannous fluoride and stannous chloride dihydrate in order to impart its beneficial effects to the oral cavity including anticaries activities.
Claims 4-6
Claim 4 limits claim 1, wherein the zinc ion source comprises zinc citrate, zinc oxide, zinc lactate, zinc phosphate, zinc chloride, or combinations thereof. Claim 5 limits claim 1, wherein the oral care composition comprises fluoride. Natsch teaches the oral care products contain oral care actives including fluorine compounds and zinc salts (for example zinc gluconate, zinc acetate, zinc citrate). See Natsch, 0031; see also Claim 3. Exemplified fluorine compounds include sodium monofluorophosphate. See Natsch, 0049. This meets Claim 6.
Response to arguments and 10/6/2025 declaration
Applicant argues that the combination of references requires too much picking and choosing in order to meet the claimed invention. However, the claims are drawn to a combination of known oral care ingredients combined together to predictably form an oral care composition. The combination does not result in an unexpected result.
Therefore, the claimed invention as a whole would have been prima facie obvious at the time the invention application was filed.
Double Patenting
Rejection maintained, slightly modified due to amendment
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, 3-7, and 12-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. US 10,123,953 B2 (reference application) in view of Natsch et al. (cited above) and Swaine et al. (cited above). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims teach an oral care mouth rinse (meets instant Claim 2) comprising (a) about 0.025% to about 0.1% cetyl pyridinium chloride, (b) about 0.025-3% anti-stain agent such as anisaldehyde, and (c) a carrier.
The reference claims do not expressly teach the oral care products:
comprising about 1.5-15% tetrasodium pyrophosphate, wherein no more than about 20% of the tetrasodium pyrophosphate is dissolved in the oral care composition in combination with the anisaldehyde and carrier or hydrated silica, SLS and CMC and disodium pyrophosphate, wherein no more than about 20% of the disodium pyrophosphate is dissolved in the oral care composition in combination with the anisaldehyde and carrier.
Natsch teaches oral care compositions (e.g., toothpaste, mouthrinse – see Claim 6, 0031) for counteracting oral malodor. See title; abstract. An example composition is disclosed as Example 6d:
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. See par. 0055. Example 6d of Natsch specifically exemplifies a mouth spray comprising 1% of an oral malodor counteracting (“OMC”) flavor composition – namely OMC Flavour A according to example 4 – wherein said OMC flavor composition contains 5% anisaldehyde.
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. See par. 0044.
Therefore, the mouth spray ultimately contains 0.05% anisaldehyde. Thus, part (b) is met. The composition also comprises deionized water, a flavoring system, and 4% Cremophor surfactant, which are all carriers. Thus, (g) is met. Although the mouth spray contains 0.2% eugenol as an antimicrobial agent (See par. 0022; claim 3), Natsch teaches the classical approach to reduce oral malodor is to combat malodor-causing bacteria by using one or more classical antibacterial agents such as triclosan, cetylpyridinium chloride, chlorhexidine. See par. 0004. Natsch teaches compositions can further contain known oral care ingredients: hydrated silica (i.e., part (d)) and sodium lauryl sulfate (SLS) (i.e., part (e)) and carboxymethylcellulose (CMC) Blanose 7MFD (i.e., part (f)). See par. 0049,0051.
Regarding the specific claimed antibacterial agent (e.g., cetylpyridinium chloride), however, one of ordinary skill in the art would have found it obvious to incorporate an antibacterial agent such as cetylpyridinium chloride because Natsch teaches the classical approach to reduce oral malodor is to combat malodor-causing bacteria by using one or more classical antibacterial agents such as cetyl-pyridinium chloride, chlorhexidine, or triclosan. See Natsch, par. 0004. Thus, one of ordinary skill in the art would have recognized that one or more classical antibacterial agent (e.g., triclosan, cetylpyridinium chloride, chlorhexidine) would have been suitable in place of 0.2% eugenol at similar concentration of eugenol. The artisan would have reasonably believed that the cetylpyridinium chloride would provide its antibacterial activity in order to reduce malodor causing bacteria. Further given that other known oral care ingredients are disclosed for the compositions including SLS, hydrated silica and CMC, the artisan would have reasonable believed these ingredients may be successfully added to an oral care composition.
Regarding about 1.5-15% tetrasodium pyrophosphate, wherein no more than about 20% of the tetrasodium pyrophosphate is dissolved in the oral care composition, it was already known that polyphosphates including pyrophosphate agents are used in oral care compositions as antitartar ingredients to help retard calculus formation. For example, Swaine teaches pyrophosphate, tripolyphosphate and hexametaphosphate are used in oral care compositions to impart antitartar efficacies. See 0004. Swaine teaches predominately undissolved pyrophosphate (i.e., no more than about 20% of the total pyrophosphate salt dissolved in the composition) is added to oral care compositions as anticalculus agents. See 0071,0073. Tetrasodium pyrophosphate is the preferred pyrophosphate used in the oral care composition. See 0073.
One of ordinary skill in the art would have found it obvious to incorporate polyphosphate and/or pyrophosphate anticalculus agents such as tetrasodium pyrophosphate in the oral care formulation of the reference claims because pyrophosphates and other polyphosphates are added to oral care compositions to help retard calculus formation. The artisan would have incorporated a pyrophosphate (e.g., tetrasodium pyrophosphate) and/or a polyphosphate as an anticalculus agent because a POSA would have reasonably believed that the OMC flavor compositions containing a polyphosphate and/or a pyrophosphate anticalculus agent can be suitably used in the oral care formulation claimed in order impart reduction of malodor and calculus formation.
Regarding the limitation wherein the antibacterial agent, the anisaldehyde, the tetrasodium phosphate and the carrier are compatible and do not reduce the composition's stability or efficacy, it does not impart patentable distinction. Natsch recognizes drawbacks of prior oral care compositions such as degradation requiring high amounts of active that lead to inefficiency and impracticality. See 0009. Natsch explicitly teaches the oral compositions as end-user products sustaining activity/efficacy. See 0048. Thus, Natsch already suggests stability. Furthermore, a POSA developing an oral care composition comprising an antibacterial, flavor aldehyde such as anisaldehyde, and a tetrasodium pyrophosphate would reasonably aim to produce a stable, effective product that maintains its activity and stability over shelf-life. Achieving compatibility and stability would have been a reasonably desired outcome of standard formulation practice to produce a product useful for its intended purpose for the end-user. Accordingly, ensuring that the components in the oral composition coexist without reducing stability or efficacy represents the predictable application of compounding. Alternatively, the utility of the reference composition is to provide oral care compositions effective to reduce oral bacteria and to prevent and treat bacteria-mediated diseases or conditions of the oral cavity including dental plaque, caries, calculus, gingivitis, periodontal disease and breath malodor formulated such that there are negative effects on its stability or efficacy are minimized. See reference col. 1:~7-13 and col. 14:42-51.
Therefore, the claimed invention as a whole would have been prima facie obvious at the time of the invention.
Claims 3 and 7
Claim 3 limits claim 1, wherein the stannous ion source comprises stannous fluoride, stannous chloride, stannous pyrophosphate, or combinations thereof. Claim 7 limits claim 5, wherein the oral care composition comprises sodium fluoride and stannous chloride. Swaine teaches that it is well-known that oral care products can provide both therapeutic and cosmetic hygiene benefits to consumers. Therapeutic benefits include caries prevention which is typically delivered through the use of various fluoride salts and gingivitis prevention by the use of an antimicrobial agent such as triclosan, stannous fluoride. Swaine teaches flavor formulations benefit from agents that have chemical reducing capability, in particular stannous ions is a preferred active in oral care compositions because of its wide range of benefits and phenolics and derivatives derived from plant sources with useful antimicrobial, anti-inflammatory and antioxidant activities. See 0041. Preferred stannous ion sources include stannous fluoride and stannous chloride dihydrate. See 0043. Swaine further teaches that fluoride ion can be used in mouthwashes and mouth sprays as an anticaries agent. See 0052. A wide variety of fluoride ion-yielding materials can be employed as sources of soluble fluoride in the present compositions. Representative fluoride ion sources include: stannous fluoride, sodium fluoride, potassium fluoride, sodium monofluorophosphate, indium fluoride and many others. Stannous fluoride and sodium fluoride are preferred. See 0066.
Claims 4-6
Claim 4 limits claim 1, wherein the zinc ion source comprises zinc citrate, zinc oxide, zinc lactate, zinc phosphate, zinc chloride, or combinations thereof. Claim 5 limits claim 1, wherein the oral care composition comprises fluoride. The reference claims do not expressly teach these ingredients. However, Natsch teaches the oral care products contain oral care actives including fluorine compounds and zinc salts (for example zinc gluconate, zinc acetate, zinc citrate). See 0031; see also Claim 3. Exemplified fluorine compounds include sodium monofluorophosphate. See 0049. This meets Claim 6. One of ordinary skill in the art would have found it obvious to incorporate sodium monofluorophosphate or zinc salts including zinc citrate as these are disclosed as beneficial agents suitable for oral care compositions.
Claims 12-14
Claim 12 limits claim 1, wherein the orally acceptable carrier comprises water. While the reference claims do not teach water, Example 6d of Natsch teaches water. One of ordinary skill in the art would have found it obvious to incorporate water into the claimed rinse in order to utilize the rinsing effects of water.
Claim 13 limits claim 1, wherein the orally acceptable carrier comprises humectant. Claim 14 limits claim 13, wherein the humectant comprises glycerin, sorbitol, xylitol, butylene glycol, polyethylene glycol, propylene glycol, trimethyl glycine, or combinations thereof. Swaine teaches suitable humectants can be used in compositions of the subject invention include edible polyhydric alcohols such as glycerin, sorbitol, xylitol, butylene glycol, polyethylene glycol, propylene glycol and trimethyl glycine. While the reference claims do not teach humectant, one of ordinary skill in the art would have found it obvious to incorporate glycerin to provide humectant activity.
Response to arguments
Applicant will consider filing a terminal disclaimer upon indication of allowable subject matter, if necessary.
Conclusion
No claims are 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 CHRIS E SIMMONS whose telephone number is (571)272-9065. The examiner can normally be reached M-F: 9:30-6:00p.
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/CHRIS SIMMONS/
Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622