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 .
Summary
Claims 1-17. All pending claims are under examination in this application.
Priority
The current application was filed on May 15, 2024 is a 371 of PCT/EP2022/083049 filed November 23, 2022. The current application claims foreign priority to GB2117188.9 filed November 29, 2021.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on May 15, 2024 is acknowledged. A signed copy of the document is attached to this office action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11 and 17 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 11 has the phrase “…selected from the group comprising…” The transition word “comprising” – rather than “consisting of” renders the claim indefinite according to MPEP 2173.05(h): A Markush grouping is a closed group of alternatives, i.e., the selection is made from the group “consisting of” (rather than “comprising” or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" or "consisting essentially of" the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim. If a claim is intended to encompass combinations or mixtures of the alternatives set forth in the Markush grouping, the claim may include qualifying language preceding the recited alternatives (such as "at least one member" selected from the group), or within the list of alternatives (such as "or mixtures thereof"). Id. at 1281. See also MPEP § 2111.03. The correct phrase is “selected from the group consisting of”.
Claim 17 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Claim 17 is written as a “use” claim and does not recite process steps. Additionally, claim 17 does not comply with the four statutory categories. It is therefore, indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 17 is directed to non-statutory subject matter. Claim 17 does not fall within at least one of the four categories of patent eligible subject matter because it is written as a “use” claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 8, 10-12, and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yue et al. (US2003/0124067A1).
Yue et al. is the closest prior art to the present application as it teaches dentifrice compositions comprising a stable low water phase comprising polyphosphate and ionic active ingredients (see title). Furthermore, Yue et al. disclose dentifrice compositions comprising in a single phase: (a) from about 0.1% to about 30% of one or more
linear polyphosphates having an average chain length of about 4 or more; (b) an ionic active ingredient selected from the group consisting of a fluoride ion source, a stannous ion source, a zinc ion source, a copper ion source and mixtures thereof, wherein the ionic active ingredient is present as a solid dispersion in the composition and delivers and effective amount of ionic active when solubilized; (c) a binder system comprised of (i) from about 0.05% to about 3% of a thickening agent selected from the group consisting of polysaccharides, carbomers, poloxamers, modified celluloses, and mixtures thereof; and (ii) from about 0.1 % to about 70% of at least one humectant; wherein the dentifrice composition has a total water content of less than about
10%. Further disclosed are methods for stabilizing dentifrice compositions by providing such a binder system (see abstract).
Regarding instant claim 1, Yue et al. teach a single phase non-aqueous dentifrice composition. The necessary citations of Yue et al. that pertain to instant claim 1 are presented in Table I.
Table I
Instant Claim 1
Yue et al. Citations
A single phase non-aqueous dentifrice composition comprising:
Yue et al. disclose a single phase non-aqueous dentifrice composition comprising: (see Example 4, paragraph [0088])
a) at least one solvent; b) stannous fluoride; c) at least one zinc salt; d) a supporting polymer; e) at least one surfactant; and f) carrageenan.
Yue et al. disclose the following additives: (a) propylene glycol, glycerin, and PEG-300, (b) stannous fluoride, (c) zinc lactate, (d) glass H polyphosphate, xanthan gum, carrageenan (e) SLS and (f) carrageenan (see Example 4, paragraph [0088]).
Regarding instant claim 2, Yue et al. teach wherein the at least one solvent comprises glycerine, polyethylene glycol (PEG) or a mixture thereof. Yue et al. disclose the propylene glycol, glycerin, and PEG-300 as solvents (see Example 4, paragraph [0088]).
Regarding instant claim 3, Yue et al. teach wherein the at least one solvent comprises glycerine 30-70% by weight and polyethylene glycol (PEG) 10-30% by weight. Yue et al. disclose that preferred humectants (solvents) are glycerin, polyethylene glycol, polypropylene glycol, and mixtures thereof, especially mixtures thereof. The humectant generally comprises from about 0.1 % to 70%, preferably from about 1 % to about 60%, and more preferably from about 15% to 55%, by weight of the composition (see paragraph [0043]). Therefore, the disclosed weight percent values within Yue et al. for the humectants (solvents) would allow for the instant claim 3 limitations.
Regarding instant claim 4, Yue et al. teach wherein the at least one zinc salt is zinc chloride. Yue et al. disclose examples of suitable zinc ion sources are zinc
oxide, zinc sulfate, zinc chloride, zinc citrate, zinc lactate, zinc gluconate, zinc malate, zinc tartrate, zinc carbonate, zinc phosphate, and other salts (see paragraph [0058]).
Regarding instant claim 5, Yue et al. teach wherein the at least one zinc salt comprises between 0.05 % and 1 % by weight of the composition. Yue et al. disclose that the combined metal ion source(s) will be present in an amount of from about 0.25% to about 11 %, by weight of the final composition. Preferably, the metal ion sources are present in an amount of from about 0.4 to about 7%, more preferably from about 0.45% to about 5% (see paragraph [0059]).
Regarding instant claim 8, Yue et al. teach wherein supporting polymer comprises between 0.1 and 1.5% by weight of the composition. Yue et al. disclose the supporting polymer, xanthan gum (polysaccharide), is present at a level of 0.350 wt/wt (see Example 4, paragraph [0088]).
Regarding instant claim 10, Yue et al. teach wherein the carrageenan comprises between 0.1 and 1% by weight of the composition. Yue et al. disclose carrageenan is present at a level of 0.600 wt/wt (see Example 4, paragraph [0088]).
Regarding instant claim 11, Yue et al. teach wherein the at least one surfactant is selected from the group comprising sodium lauryl sulphate (SLS) and cocamidopropyl betaine. Yue et al. disclose the presence of the surfactant, SLS (see Example 4, paragraph [0088]).
Regarding instant claim 12, Yue et al. teach wherein the composition comprises both SLS and cocamidopropyl betaine. Yue et al. disclose the possibility of including both surfactants, SLS and cocamidopropyl betaine (see paragraph [0073]).
Regarding instant claims 15 and 16, Yue et al. teach wherein the composition comprises an anti-staining agent, and wherein the composition comprises one or more additional ingredients selected from dental silicas, thickening silicas, flavourings, colourants, preservatives, pH modifiers, rheology modifiers, and abrasives. Yue et al. disclose the use of an anti-staining agent (see claim 8; also see paragraphs [0082] and [0018]). Also, Yue et al. disclose the dentifrice composition can include additional inorganic thickening agents, buffering agents, anticalculus agents, abrasive polishing materials, peroxide sources, alkali metal bicarbonate salts, surfactants, titanium dioxide, coloring agents, flavor systems, sweetening agents, antimicrobial agents, herbal agents, desensitizing agents, stain reducing agents, and mixtures thereof (see claim 8; also see paragraphs [0082] and [0018]).
Claims 1 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Glandorf et al. (WO2007/076001A2).
Glandorf et al. teach oral care compositions comprising zinc and phytate (see title). Additionally, Glandorf et al. disclose oral care compositions and their use, compri sing in an orally acceptable carrier: (a) from about 0.01 % to about 10 % by weight of an essentially water-insoluble zinc compound, and (b) from about 0.01 % to about 10 % by weight of a compound having C-O-P bonds selected from polyphosphorylated inositol compounds such as phytic acid, myo-inositol pentakis(dihydogen phosphate); myo-inositol tetrakis(dihydrgen phosphate), myo-inositol trikis(dihydrogen phosphate), and an alkali metal, alkali earth metal or ammonium salt thereof. The compositions are effective in preventing and controlling oral cavity conditions including plaque, calculus, caries, periodontal disease, mouth malodor and dental erosion and have acceptable aesthetics without the unpleasant astringent and metallic taste associated with the use of zinc (see abstract).
Regarding instant claim 1, Glandorf et al. teach a single phase non-aqueous dentifrice composition. The necessary citations of Glandorf et al. that pertain to instant claim 1 are presented in Table II.
Table II
Instant Claim 1
Glandorf et al. Citations
A single phase non-aqueous dentifrice composition comprising:
Glandorf et al. disclose a non-aqueous single phase dentifrice composition comprising (see Example IG)
a) at least one solvent; b) stannous fluoride; c) at least one zinc salt; d) a supporting polymer; e) at least one surfactant; and f) carrageenan.
Glandorf et al. disclose the following additives: (a) propylene glycol, glycerin and PEG, (b) stannous fluoride, (c) zinc lactate, (d) polyphosphate, xanthan gum, carrageenan (e) SLS and (f) carrageenan.
Regarding instant claim 14, Glandorf et al. teach wherein the composition further comprises an additional source of fluoride. Glandorf et al. disclose wherein the composition further comprises an additional source of fluoride (see claim 5).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 6-7, 9, 13, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Yue et al. in view of Glandorf et al. and Groves et al. (US2013/0095045A1).
[The Examiner is going to introduce each new reference and then combine them where appropriate to reject the instant claims.]
1. Groves et al.
Groves et al. teach non-aqueous oral care compositions (see title). In addition, Groves et al. disclose that the invention provides a non-aqueous oral care composition
with a liquid continuous phase comprising a thickening agent, a humectant, and one or more liquid polyethylene glycols having a melting point below 25° C, in which the liquid continuous phase is structured with crystals of one or more solid polyethylene glycols having a melting point of 25° C or above. The rheological behaviour of the composition of the invention corresponds well with the characteristic rheological behaviour of typical aqueous dentifrice formulations (see abstract).
The teachings of Yue et al. and Glandorf et al. are presented above within the 35 U.S.C. §102 section.
Combination of Yue et al., Glandorf et al., and Groves et al.
Regarding instant claims 6 and 7, Yue et al., Glandorf et al., and Groves et al. teach wherein the supporting polymer is a polyacrylic acid (PAA). Groves et al. disclose that specific examples of such materials are homopolymers of acrylic acid cross-linked with allyl ethers of sucrose or pentaerythritol and homopolymers of acrylic acid cross-linked with divinyl glycol. The most preferred carboxyvinyl polymer for use in the compositions of the present invention is a homopolymer of acrylic acid crosslinked with allyl ethers of pentaerythritol, which is slightly pre-neutralised (1 to 3%) by potassium salt. This pre-neutralisation is done in order to precipitate polyacrylic acid in the presence of the polymerization solvent. Such a material is commercially available, for
example, as CARBOPOL® 974P NF Polymer, ex Lubrizol Advanced Materials, Inc. Mixtures of any of the above described materials may also be used (see paragraph [0012]; also see paragraph [0057]; both within Groves et al.).
Regarding instant claim 9, Yue et al., Gandorf et al., and Groves et al. teach wherein the PEG has a molar mass between 380 and 420 grams per mol. Groves et al. disclose the use of PEG 400 (see paragraph [0050] within Groves et al.).
Regarding instant claim 13, Yue et al., Glandorf et al., and Groves et al. teach wherein the dentifrice comprises: a) glycerine, between 52 - 55 % by weight; b) PEG 400, between 18 - 22 % by weight; c) stannous fluoride; d) zinc chloride, between 0.2 - 0.4 % by weight; e) a high molecular weight PAA polymer, between 0.6 - 0.8 % by weight; f) a 3:1 weight ratio of surfactants sodium laurel sulphate and cocamidopropyl betaine between 1.0 - 2.4 % by weight; and g) carrageenan, between 0.1 to 0.4 % by weight. The following is a cited list of additives for the dentifrice composition:
(a) and (b); Yue et al. disclose the use of humectants (solvents) relevant to instant claim 13. Suitable humectants for use in the invention include glycerin, sorbitol, polyethylene glycol, propylene glycol, xylitol, and other edible polyhydric alcohols. Preferred are glycerin, polyethylene glycol, polypropylene glycol, and mixtures thereof, especially mixtures thereof. The humectant generally comprises from about 0.1 % to 70%, preferably from about 1 % to about 60%, and more preferably from about 15% to 55%, by weight of the composition (see paragraph [0043] within Yue et al.).
(c); Yue et al. disclose that the fluoride ion source herein is a soluble fluoride source capable of providing free fluoride ions. Soluble fluoride ion sources include sodium fluoride, stannous fluoride, indium fluoride, zinc fluoride, and sodium monofluorophosphate. Sodium fluoride and stannous fluoride are the preferred soluble fluoride ion sources (see paragraph [0050] within Yue et al.).
(d); Please see the discussion and citations within instant claims 4 and 5 for the relevant rejection text.
(e); Please see the discussion and citations within instant claims 6 and 7 for the relevant rejection text establishing the use of the homopolymer of PAA, CARBOPOL ® 974P. Additionally, Groves et al. disclose that the above thickening agent ranges from 0.05 to 5%, preferably from 0.1 to 2%, more preferably from 0.2 to 0.5% by total weight carboxyvinyl polymer based on the total weight of the composition (see paragraph [0013] within Groves et al.).
(f); Please see the discussion and citations within instant claims 11 and 12 regarding the surfactants for the relevant rejection text. Also, Yue et al. disclose that the present composition typically comprises one or more surfactants each at a level of from about 0.25% to about 12%...(see paragraph [0073] within Yu et al. Therefore, Yue et al. allows for a 3:1 weight ratio of surfactants sodium laurel sulphate and cocamidopropyl betaine between 1.0 - 2.4 % by weight [for example, 0.18 wt% SLS : 0.6 wt% cocamidopropyl betaine].
(g); Yue et al. disclose carrageenan levels 0.1-0.4 wt% (see Examples 12-18 within Yue et al.).
Regarding instant claims 17, Yue et al., Glandorf et al., and Groves et al. teach the use of the single phase non-aqueous dentifrice composition of instant claim 1 in combination with a toothbrush to clean teeth. Please see the discussion and citations within instant claim 1 for the relevant rejection text (see instant claim 1 within Yue et al.). Furthermore, Yue et al. disclose that the dispenser for the dentifrice compositions may
be a tube, pump, or any other container suitable for dispensing toothpaste (see paragraph [0083] within Yue et al.). Thus, it would be obvious for a skilled artisan (POSITA; person of ordinary skill in the art) to apply this dentifrice to a toothbrush to clean teeth.
Analogous Art
The Yue et al., Glandorf et al., and Groves et al. references are directed to the same field of endeavor as the instant claims, that is, a single phase non-aqueous dentifrice composition as disclosed within instant claim 1.
Obviousness Analysis
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the dentifrice composition disclosed by Yue et al., using the teachings of Glandorf et al. and Groves et al. in order to arrive at the subject matter of the instant claims.
The Yue et al., Glandorf et al., and Groves et al. references all have considerable overlap in the preparation of dentifrice compositions. In this instance, Yue et al. and Glandorf et al. supply the overall additives and preparation process for the dentifrice composition, while Groves et al. supplies the specific polyacrylic acid derivative and PEG 400 variant. All references are directed to dentifrice compositions and therefore constitute analogous art under MPEP §2141.01(a). A POSITA would have reasonably consulted the three references when seeking to develop a dentifrice composition or toothpaste formulation.
Starting with Yue et al., the skilled person only had to try the necessary claim limitations disclosed by both Glandorf et al. and Groves et al. The combination of Yue et al., Glandorf et al., and Groves et al. would allow one to arrive at the present application without employing inventive skill. This combination of the dentifrice composition taught by Yue et al. along with the use of the necessary claim limitations taught by both Glandorf et al. and Groves et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application. It would have only required routine experimentation to modify the dentifrice composition disclosed by Yue et al. with the use of the necessary claim limitations taught by both Glandorf et al. and Groves et al. Incorporating the disclosure of Yue et al. into the dentifrice composition taught by both Glandorf et al. and Groves et al. represents a predictable use of prior art elements according to their established functions, consistent with MPEP §2143 and KSR.
Furthermore, the additional claim limitations taught by both Glandorf et al. and Groves et al. would have been viewed by a POSITA as routine design optimizations or known modifications for a dentifrice compositions. Implementing these features in Yue et al.’s dentifrice composition for oral care would not require more than ordinary skill or routine experimentation.
Accordingly, the combination of Yue et al., supplemented by both Glandorf et al. and Groves et al. provides all the elements of the claimed invention. The resulting dentifrice composition constitutes no more than the predictable outcome of combining familiar prior art components, and therefore the claimed subject matter would have been obvious to a POSITA prior to the effective filing date of the invention.
Conclusion
No claims are allowed.
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/JOHN W LIPPERT III/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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