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 .
Applicants' arguments, filed 02/04/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
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.
Previous
1) Claim(s) 1, 5, 8, 10-12, 15-18 remain rejected under 35 U.S.C. 103 as being unpatentable over Colgate (IE914446). The rejection also applies to newly added claim 21.
Colgate teaches, “An oral composition such as a toothpaste . . . containing a calculus-inhibiting amount of a linear molecularly dehydrated polyphosphate salt and, as inhibitor of enzymatic hydrolysis of said polyphosphate salt in saliva, a synthetic polyvinyl phosphonate” (Abstract).
Colgate teaches a specific embodiment of a toothpaste comprising 20.12% water, 6.00% sodium hexametaphosphate (first linear polyphosphate), 1% xanthan, 3% silica thickener, 0.5% PVPA, 0.76% sodium monofluorophosphate (a fluoride source), 40% calcium pyrophosphate (second linear polyphosphate; abrasive), 0.5% sodium benzoate, 1.2% sodium lauryl sulfate (p. 16, Example 3, Part D).
This embodiment comprises calcium pyrophosphate, which is one of a group of abrasives taught in the reference. It is not required for the practice of the invention; thus, it would have been obvious to exclude it. It may be replaced by the myriads of polishing agents disclosed in the reference, such as “silica” (see p. 8, 2nd paragraph), as per claim 19.
This embodiment is also free of peroxide or a whitening agent other than the polyphosphate, as per claims 8, 17-18.
In regard to the second linear polyphosphate comprising pyrophosphate, Colgate teaches, “any mixtures thereof” of “linear molecularly dehydrated polyphosphate salts, such as hexametaphosphates, tripolyphosphates and pyrophosphates, which are operative herein as anticalculus agents”, wherein pyrophosphates include “tetrasodium pyrophosphate, and are “generally employed in the instant oral compositions in approximate weight amounts of about 0.1 to 7%” (p. 4, last paragraph). Accordingly, it would have been obvious to have a mixture of 1% hexametaphosphate, and 1% tetrasodium pyrophosphate, which provides a weight ratio of 1:1, as claimed.
In regard to claim 11, Colgate teaches, “the linear molecularly dehydrated polyphosphates may contain about 2 to 125 phosphorous atoms” (p. 4, last paragraph). Accordingly, it would have been obvious to provide a first linear polyphosphate having an average chain length of from about 8 to about 14.
The pH is “generally in the range of from about 4.5 to about 9” (p. 7, 4th paragraph), which makes obvious the claimed range of about 5 or less.
The compositions include “polishing material”, i.e. abrasives, “is generally present in the solid or pasty compositions in weight concentrations of about 10% to about 99%” (p. 9, 2nd paragraph), which makes obvious the claimed range of about 5% to 25%, by weight.
Since the prior art comprises a polyphosphate source comprising a first linear polyphosphate with an average length of from about 6 to about 21, having a ΔE value of about 3 or less, as per claim 12, would have been implicit.
The compositions further comprise “polyvinylpyrrolidone” (p. 10, 2nd paragraph; clm. 10), “sorbitol” (p. 9, last paragraph; clm. 15), a cellulose polymer (p. 10, 2nd paragraph; clm. 16).
In regard to claim 1 and 21, “the liquid vehicle may comprise water and humectant in an amount from about 10% to about 90% by weight of the preparation” and further “about 3-30 wt.% water” (p. 9, last paragraph). Accordingly, it would have been obvious for the compositions to comprise 20% to about 25% or about 21% to about 25% water.
The prior art is not anticipatory insofar as it does not require a pH of about 5 or less, nor wherein the compositions are free of calcium pyrophosphate. However, the limitations are prima facie obvious insofar as the prior art teaches a pH range the overlaps with the claimed range, i.e. about 4.5 to about 9 (MPEP 2144.05), and the calcium pyrophosphate is not required and may simply be replaced with another abrasive recited therein, such as aluminum silicate.
2) Claim(s) 11 remains rejected under 35 U.S.C. 103 as being unpatentable over Colgate (IE914446) as applied to claim 1 above, and further in view of White et al., (the Journal of Contemporary Dental Practice 2000).
Colgate, which is taught above, differs from claim 11 insofar as it does not teach a linear polyphosphate having an average chain length of from about 8 to about 14.
White et al. teaches, “This introductory article aims to introduce professionals, educators, and researchers on the rationale behind the development of an improved cleaning dentifrice formulation, Crest® Multicare Advanced Cleaning [CMAC]. This new dentifrice is based upon the application of an improved tartar control/cleaning ingredient that is a polymeric adjunct of a pyrophosphate anion commonly applied in tartar control and stain control whitening dentifrices” (Abstract).
White et al. further teaches, “The polymeric phosphate applied in CMAC is a Glass H ‘hexametaphosphate,’ a polymer of pyrophosphate with 10-12 repeating pyrophosphate subunits. . . . Relative to pyrophosphate precursors [sic], this polypyrophosphate dentifrice may offer significant clinical advantages with respect to extrinsic dental stain and calculus control efficacy” (p. 10, Discussion, left column).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to add a linear polyphosphate having an average chain length of from about 8 to about 14 to the compositions of Colgate in view of the prior art teaching of advantages with respect to extrinsic dental stain and calculus control efficacy for Glass H ‘hexametaphosphate,’ a polymer of pyrophosphate with 10-12 repeating pyrophosphate subunits. The artisan would have reasonably expected success with the combination insofar as the compositions Colgate comprise hexametaphosphate and linear phosphates having about 2 to 125 phosphorus atoms.
New By Amendment
3) Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Colgate (IE914446) as applied to claim 1 above, and further in view of Joziac et al., (WO 2014/185884).
Colgate, which is taught above, differs from claim 20 insofar as it does not teach a PCR/RDA ratio of about 0.65 or greater.
Joziac et al. teaches an oral care composition comprising an abrasive system, wherein “the amount and particle size of the first and second particulate abrasives are selected to provide the oral composition with a pellicle cleaning ratio (PCR) of at least 59, a radioactive dentin abrasion (RDA) of no more than 250, and a ratio of the pellicle cleaning ratio (PCR) to the radioactive dentin abrasion (RDA) of at least 0.6. Further optionally, the amount and particle size of the first and second particle abrasive are selected to provide the oral care composition with a pellicle cleaning ratio (PCR) of from 70 to 110, a radioactive dentin abrasion (RDA) of from 100 to 140, and a ratio of the pellicle cleaning ratio (PCR) to the radioactive dentin abrasion (RDA) of from 0.6 to 0.8, optionally from 0.64 to 0.8” (p. 4-5, para. [0026]).
Joziac et al. further teaches, “as is well known in the art it is important that the prophy pastes have a high pellicle cleaning ratio (PCR) and a low radioactive dentine abrasion (RDA). The overall efficacy may be expressed as a ratio between the pellicle cleaning ratio (PCR) and the radioactive dentin (RDA) – the higher the PCR/RDA ratio, the more effective is the prophy composition to achieve high tooth surface cleaning but with low abrasion of the tooth enamel surface” (p. 16, para. [0082]).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to modify the amount and particle size of abrasive in the prior art compositions in order to provide the prior art with an effective composition that achieves a PCR/RDA ratio of 0.65 or greater motivated by the desire to achieve high tooth surface cleaning but with low abrasion of the tooth enamel surface, as taught by Joziac et al.
3) Claim(s) 1, 5, 8, 10-12, 15-18 remain rejected under 35 U.S.C. 103 as being unpatentable over Yue et al., (US 2003/0003061, cited in IDS).
Yue et al. teaches oral care compositions comprising “an effective amount of one or more linear polyphosphate having an average chain length of about 4 or more”, “a fluoride ion source”, “about 6% to about 70% of an abrasive polishing material containing less than 23% calcium” (Abstract).
Yue et al. teaches a specific embodiment of an oral care composition comprising 13% Glass H polyphosphate (first linear polyphosphate), 0.243% sodium fluoride (fluoride ion source), 2.1% stannous chloride, 4% tetrasodium pyrophosphate (second linear polyphosphate), 21% Silica (Zeodent 119; abrasive), 3% poloxamer, 5.41% water (p. 6-7, para. [0079], Example 3).
Here the ratio of first linear polyphosphate to second linear polyphosphate is 13:4 or 3.25:1, which falls within the claimed range of about 4:1 to 1:1, as per claims 3-4. This embodiment is also free of calcium pyrophosphate, peroxide, oxidizer, or enzyme, as per claims 8-9.
Buffering agents are taught to be used to adjust the “pH of the compositions to a range of about pH 6.5 to about pH 10” (p. 3, para. [0038]), which is close enough to the claimed pH range of about 5 or less, especially since they both read on having an acidic pH [see instant specification at p. 27, Table 8, and lines 18-21, wherein dentifrice E-I having a pH from 6.5-6.9 “removed stain extremely well with values of E<3 despite having only a slightly acidic pH”]. MPEP 2144.05 states that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties.Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.).”
The compositions are taught to have a “total water content being from about 1% to about 20%” (p. 4, para. [0058]), which makes obvious to claimed range of about 20% to about 25%. Also the prior art range appears to be close enough that one skilled in the art would have expected them to have the same properties, as per MPEP 2144.05.
Sodium monofluorophosphate is taught to be a suitable source of fluoride ions for the dentifrice (p. 2, para. [0029]).
“The polyphosphate source will typically comprise from about 0.5% to about 30%” (p. 2, para. [0027]), as per claim 5.
The compositions may further comprise “sorbitol” (p. 4, para. [0052]; clm. 15), a cellulose polymer (p. 5, para. [0064]; clm. 16), and “carboxyvinyl polymers” (Id.), which make obvious polyvinylpyrrolidone, as per claim 10.
The prior art teaches a combination of water, a fluoride ion source, a first and second polyphosphate source, and abrasives. The prior art is not anticipatory insofar as it does not require about 20% to about 25% water or a pH of about 5 of less. However, the claimed invention is prima facie obvious insofar as the amounts of water and pH appear to be close enough to the claimed ranges to provide the same properties, as discussed above.
4) Claim(s) 14 remains rejected under 35 U.S.C. 103 as being unpatentable over Yue et al., (US 2003/0003061, cited in IDS) as applied to claim 1 above, and further in view of Coll-Palagos et al., (US 4,309,409)
Yue et al., which is taught above, differs from claim 14 insofar as it does not teach phosphoric acid.
Coll-Palagos et al. teaches toothpaste formulations comprising acidic pH adjusters, wherein “Phosphoric acid and its salts . . . give the best long term results” (col. 2, lines 20-30).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to use phosphoric acid as the pH adjusting agent in the compositions of Yue et al. since phosphoric acid is said to give the best long term results, as taught by Coll-Palagos et al.
5) Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yue et al., (US 2003/0003061, cited in IDS) as applied to claim 1 above, and further in view of Joziac et al., (WO 2014/185884).
Yue et al., which is taught above, differs from claim 20 insofar as it does not teach a PCR/RDA ratio of about 0.65 or greater.
Joziac et al. teaches an oral care composition comprising an abrasive system, wherein “the amount and particle size of the first and second particulate abrasives are selected to provide the oral composition with a pellicle cleaning ratio (PCR) of at least 59, a radioactive dentin abrasion (RDA) of no more than 250, and a ratio of the pellicle cleaning ratio (PCR) to the radioactive dentin abrasion (RDA) of at least 0.6. Further optionally, the amount and particle size of the first and second particle abrasive are selected to provide the oral care composition with a pellicle cleaning ratio (PCR) of from 70 to 110, a radioactive dentin abrasion (RDA) of from 100 to 140, and a ratio of the pellicle cleaning ratio (PCR) to the radioactive dentin abrasion (RDA) of from 0.6 to 0.8, optionally from 0.64 to 0.8” (p. 4-5, para. [0026]).
Joziac et al. further teaches, “as is well known in the art it is important that the prophy pastes have a high pellicle cleaning ratio (PCR) and a low radioactive dentine abrasion (RDA). The overall efficacy may be expressed as a ratio between the pellicle cleaning ratio (PCR) and the radioactive dentin (RDA) – the higher the PCR/RDA ratio, the more effective is the prophy composition to achieve high tooth surface cleaning but with low abrasion of the tooth enamel surface” (p. 16, para. [0082]).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to modify the amount and particle size of abrasive in the prior art compositions in order to provide the prior art with an effective composition that achieves a PCR/RDA ratio of 0.65 or greater motivated by the desire to achieve high tooth surface cleaning but with low abrasion of the tooth enamel surface, as taught by Joziac et al.
Response to Arguments
i) Applicant argues that the notion of excluding calcium pyrophosphate from the embodiment of Colgate is based on impermissible hindsight bias and “Colgate provides no motivation to remove a principle abrasive component explicitly taught and employed . . .” (p. 4-5)
The Examiner disagrees.
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).
MPEP 2144.06, sec. II states, “In order to rely on equivalence as a rationale supporting an obviousness rejection, the equivalency must be recognized in the prior art, and cannot be based on applicant’s disclosure or the mere fact that the components at issue are functional or mechanical equivalents.”
In this case, calcium pyrophosphate is recognized as an equivalent polishing agent along with other polishing agents such as “siliceous polishing agent” (p. 8, 2nd paragraph). Accordingly, it would have been obvious to replace one polishing agent for another, i.e. it would have been obvious to replace the calcium pyrophosphate with siliceous polishing agent or any other listed in the group.
ii) Applicant argues that the prior art unexpectedly provides a PCR/RDA ratio of about 0.65 or greater.
However, there is no support in the specification for the notion that the results are “unexpected”, as this term cannot be found anywhere in the instant disclose. This is merely conclusory statement by the attorney. Nevertheless, having a PCR/RDA ratio of 0.65 or greater for a toothpaste was well-known at the time of applicant’s filing. Joziac et al. teaches “the ratio of PCR to RDA is at least about 0.6 or greater” (p. 5, para. [0031]) in order “to achieve high tooth surface cleaning but with low abrasion of the tooth enamel surface” (p. 16, para. [0082]).
iii) Applicant argues, “the disclosure in Colgate fails to account for the significant and unexpected improvement in stain removal demonstrated by Applicant’s inventive compositions at lower pH values.
Again, the notion that the results shown in the specification are unexpected stems solely form the attorney of record.
The compositions of Colgate are taught to be acidic insofar as it teaches that the pH is generally in the range of from about 4.5 to about 9.
Moreover, Appellant must demonstrate a difference between the claimed invention and the closest prior art. In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) (“[W]hen unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.”). In this case Colgate represents the closest prior art insofar as it comprises a first linear polyphosphate with an average chain length of about 6 to about 21 and a second polyphosphate comprising pyrophosphate. Due to the absence of tests comparing applicant's claimed invention with those of the closest prior art, applicant's assertions of unexpected results constitute mere argument.
iii) Concerning Yue, Applicant argues, “The Examiner’s argument that these ranges are close enough is overcome by the clear and unexpected superior stain removal performance observed in the instant application at lower pH values” (p. 7).
The Examiner disagrees.
The artisan would have reasonably expected similar efficacy at a pH 6.5 of the prior art insofar as it is in the acidic range. Applicant’s showing is supportive insofar as it teaches, at p. 27, Table 8, and lines 18-21, wherein dentifrice E-I, having a pH from 6.5-6.9 “removed stain extremely well with values of E<3 despite having only a slightly acidic pH.”
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 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.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/WALTER E WEBB/ Primary Examiner, Art Unit 1612