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 .
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.
1) Claims 1, 2, 6, 11, 18 are rejected under 35 U.S.C. 103 as being unpatentable over in Bhattacharya et al. (Economic Botany, 2003) and Krofta et al., (KVASNY PRUM. 60/2014) and further in view of Beddie (WO 2007/012080, cited in IDS).
Bhattacharya et al. teaches the inhibition of Streptococcus mutans and other oral Streptococci by Humulus Lupulus L (Hop) (Ti).
“We report the inhibition of the causative agents of dental caries, Streptococcus mutans and other oral streptococci, by the antimicrobial active ingredients of the hop plant (Humulus lupulus L). The hop constituents studied were purified beta acid, canthohumol, iso alpha acid and tetra iso-alpha acid” (Abstract).
Since Bhattacharya et al. teaches, “The beta acids (lupulones) have been reported to have greater antimicrobial activity than the iso-alpha acid (humulone) against Staphylococcus aureus” (p. 118, last paragraph through 119), it would have been obvious to use purified hop beta acids to the exclusion of alpha acids. Note: lupulone is a non-hydrogenated hops beta acid.
Table 2 below shows hop beta acid to be more efficient at killing S. mutans compared to alpha acids and thymol, insofar as hop beta acid had the lowest MIC:
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300
524
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(p. 121).
The reference further teaches, “Hop beta acid has more antimicrobial activity than commonly used antiseptics in mouthwashes in our assays. There was no rapid development of resistance to beta acid” (p. 123, Conclusion 2nd paragraph).
The reference concluded, “Since oral pathogens are vertically transmissible (Hanada 2000), increase in the use and increase in variety of alternative, natural antimicrobial oral treatments might not only reduce the incidence of caries in individuals but may have wider effect on dental pathogen prevalence among human populations” (p. 123, last paragraph).
Bhattacharya et al. does not teach fluoride or chlorhexidine. Accordingly, it would have been obvious for oral care formulations to be free of fluoride, chlorhexidine or silica.
The artisan would have reasonably expected the compositions Bhattacharya et al. to provide a percent glycolysis inhibition of at least 60% in an in vitro Plaque Glycolysis Model, since the compositions comprise lupulone (purified beta acids), which is capable of killing Streptococcus mutans, which is the only bacteria in the oral cavity which excretes the plaque forming, insoluble, high-molecular weight carbohydrate.
In regard to isolated beta acids, Krofta et al. teaches, “The Hopsteiner company has recently marketed a product named Beta Bio 451 with a 45% content of beta acids” (see p. 102, right column, 4th paragraph; clm. 18). Accordingly, it would have been obvious to use the Hopsteiner company’s Beta Bio product, as source of beta acids for use in oral care compositions.
The combination of Bhattacharya et al. and Krofta et al. does not teach a suitable concentration for the hop acid nor an abrasive.
Beddie teaches, “oral care products that inhibit the microorganisms that cause dental caries and periodontal disease using natural resins” (p. 1, lines 18-19).
Beddie claims a “method of treating or preventing dental caries, gingivitis and other periodontal diseases” by “contacting an oral bacteria” with the compositions (p. 10, Claim 1), wherein the compositions further include “hop beta acids” (Id. at Claim 9), and the composition “is a toothpaste” (p. 11, Claim 11).
The compositions comprise “hop resins, hop extracts, hop acids or hop acid derivatives” (p. 2, lines 5-6) including alpha and beta acids (Id. line 12). “In one embodiment, the hop acids are beta acids selected from the group consisting of lupulone, colupulone, adlupulone and derivatives thereof” (Id. lines 15-17). Hop acids are taught to be present in the oral care composition “between about 0.001 and 0.1%” or “between about 1 and 99%” (Id. lines 18-22).
The compositions may be in the form of “powders, pastes, gums, gels, solutions and the like for rinsing, brushing, washing, chewing or topical application to the oral cavity” (p. 5, lines 18-20), where “[t]oothpastes” comprise “a slurry of an abrasive, a humectant, a thickening agent, fluoride, surfactants and flavors” (Id. lines 25-26).
Suitable abrasives “include silica precipitates, anhydrous dicalcium phosphate, dehydrated dicalcium phosphate, hydrated alumina, calcium carbonate, sodium bicarbonate, sodium metaphosphate, and mixtures thereof” (Id. lines 26-28).
“The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)” (see MPEP 2144.07).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to add an abrasive to the oral care formulation of Bhattacharya et al. since oral care formulations, e.g., toothpaste, comprise abrasives, such as calcium carbonate, as taught by Beddie.
Concerning the amount of hops acid, the artisan would have reasonably been expected to use an effective amount of hops acid sufficient for inhibiting or treating caries. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." The prior art, Beddie, suggests that the instant claimed concentration would have been suitable for purposes of oral care. Accordingly, it would have been obvious to provide from about 0.01% to about 10%, by weight of the composition of the hops extract of Bhattacharya et al. in an oral care formulation.
2) Claim(s) 3-5, 7-10, 12-16, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bhattacharya et al. (Economic Botany, 2003) and Krofta et al., (KVASNY PRUM. 60/2014) and further in view of Beddie (WO 2007/012080, cited in IDS) as applied to claims 1, 2, 6, 11, 18 above, and further in view of Glandorf et al., (US 2008/0138298).
The combination of Bhattacharya et al., Krofta et al., and Beddie, which is taught above, differs from claim 3-5, 12-13, insofar as it does not teach a metal ion source.
Glandorf et al. teaches oral care formulations comprising “from about 0.01 to about 10% by weight of an essentially water-insoluble zinc compound” (metal ion source), wherein the formulations “are effective in preventing and controlling conditions including plaque, calculus, caries, periodontal disease, mouth malodor and dental erosion” (Abstract).
Glandorf et al. further teaches, “Other antimicrobials such as copper salts, zinc salts and stannous salts may also be included” (p. 6, para. [0062]). “These agents, which provide anti-plaque benefits, may be present at levels of from about 0.01% to about 5.0% by weight of the dentifrice composition” (Id.). The prior art provides an embodiment having “1.5% Stannous Chloride” (Example I, p. 8, para. [0092]).
Concerning the in vitro Plaque Glycolysis Model, the prior art teaches, “Antimicrobial efficacy of the present compositions is measured using the in vitro Plaque Glycolysis and Regrowth Model (i-PGRM)” (p. 9, para. [0093]), wherein an “ideal i-PGRM score should approach 100%” (p. 10, para. [0098]). Results of i-PGRM assay are provided below:
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200
448
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(p. 10, para. [0098]). Stannous and zinc are shown to provide an i-PGRM score of 100 and more.
In view of this, the artisan would have been motivated to provide the compositions of Bhattacharya et al. with an i-PGRM score of 100% or more for the sake of antimicrobial efficacy. Accordingly, the claimed property of a percent glycolysis inhibition of at least 60% in an in vitro Plaque Glycolysis Model, would have been obvious.
In regard to claim 7, Glandorf teaches adding “buffering agents”, which are “typically included at a level of from about 0.5% to about 10%, by weight of the present compositions” (p. 7, para. [0082]).
In regard to claim 8-10, 14-15, abrasives such as “calcium carbonate” (p. 4, para. [0044], may be present “from about 6% to about 70%; toothpastes preferably contain from about 10% to about 50% abrasives, by weight of the composition” (p. 4, para. [0047]).
In regard to claim 16, flavoring and sweetening agents may also be added, where the “composition preferably contains from about 0.1% to about 10%” of sweetening agents (p. 7, para. [0076]).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to add a metal ion source, i.e. zinc, stannous, to the compositions of Bhattacharya et al. for the advantage of preventing and controlling conditions including plaque, calculus, caries, periodontal disease, mouth malodor and dental erosion, as taught by Glandorf et al. Since Bhattacharya et al. only teaches use of hops beta acid, it would have been obvious for the compositions to consist of the hops extract and the additional metal ion source taught by Glandorf et al.
3) Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bhattacharya et al. (Economic Botany, 2003) and Krofta et al., (KVASNY PRUM. 60/2014) and further in view of Beddie (WO 2007/012080, cited in IDS) as applied to claim 1 above, and further in view of Mello et al., (US 2013/0078197).
The combination of Bhattacharya et al., Krofta et al., and Beddie, which is taught above, differs from claim 17, insofar as it does not teach arginine.
Mello et al. teaches oral care compositions comprising “arginine in free or salt form”, which is “useful in the treatment of a variety of oral disorders, in which the composition can provide blockage of dentinal tubules, while at the same time provide antibacterial and anti-caries efficacy” (Abstract)
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to add arginine to the compositions of Bhattacharya et al. for the advantage of blocking dentinal tubules, and at the same time provide antibacterial and anti-caries efficacy, as taught by Mello et al.
Technological Background
1) The prior art made of record is considered pertinent to applicant's disclosure van der Kerk et al. US 4,039,655 (cited in IDS). van der Kerk et al. is pertinent for teaching, “Streptococcus mutans (by its action on saccharose) has been identified as the only bacteria in the oral cavity which excretes the plaque forming, insoluble, high-molecular weight carbohydrate. Therefore, the suppression of the growth of Streptococcus mutans would significantly reduce caries formation by eliminating the formation of plaque” (col. 1, lines 45-51)).
Nonstatutory Obvious-type Double Patenting
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
1) Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-12, 17-21 of copending Application No. 17/704,023 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim compositions for application to the oral cavity comprising a fluoride free oral care composition comprising a hops beta acid and metals such as tin and zinc.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
2) Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of copending Application No. 18/755,888 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim compositions for application to the oral cavity comprising a fluoride free oral care composition comprising a hops beta acid including metals such as tin and zinc.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
3) Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 18/755,788 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim compositions for application to the oral cavity comprising a fluoride free oral care composition comprising a hops beta acid including metals such as tin and zinc.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
4) Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-28, 30-31 of copending Application No. 18/322,652 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim compositions for application to the oral cavity comprising a fluoride free oral care composition comprising a hops beta acid including metals such as tin and zinc.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
5) Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-15, 23-24 of copending Application No. 17/485,552 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim compositions for application to the oral cavity comprising a fluoride free oral care composition comprising a hops beta acid including metals such as tin and zinc.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
6) Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, 10-12, 28, 42, 44-47 of copending Application No. 17/485,550 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim compositions for application to the oral cavity comprising a fluoride free oral care composition comprising a hops beta acid including metals such as tin and zinc.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
7) Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-8, 10, 11, 13-29 of copending Application No. 17/704,027 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim compositions for application to the oral cavity comprising a fluoride free oral care composition comprising a hops beta acid including metals such as tin and zinc.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
8) Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-7, 9-11, 13-21 of copending Application No. 18/655,468 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim compositions for application to the oral cavity comprising a fluoride free oral care composition comprising a hops beta acid including metals such as tin.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
9) Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-25 of copending Application No. 17/485,553 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim compositions for application to the oral cavity comprising a fluoride free oral care composition comprising a hops beta acid including metals such as tin and zinc.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
10) Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,918,681. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim compositions for application to the oral cavity comprising a fluoride free oral care composition comprising a hops beta acid including metals such as tin and zinc.
11) Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,653,773. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim compositions for application to the oral cavity comprising a fluoride free oral care composition comprising a hops beta acid including metals such as tin and zinc.
12) Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,690,792. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim compositions for application to the oral cavity comprising a fluoride free oral care composition comprising a hops beta acid including metals such as tin and zinc.
Conclusion
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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
/WALTER E WEBB/Primary Examiner, Art Unit 1612
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