DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/01/2025 has been entered.
Applicants' arguments, filed 12/01/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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--Previous
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, 5-7, 11, 14-20 remain rejected under 35 U.S.C. 103 as being unpatentable over in Beddie (WO2007/012080, cited in IDS) and Krofta et al., (KVASNY PRUM. 60/2014) and further in view of Baig et al., (US 2016/0324741, cited in IDS).
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). Note: these hops beta acids are not hydrogenated insofar as they lack the “tetrahydro” suffix. Hydrogenated hops are not required and thus obvious to exclude.
Beddie further teaches, “the term ‘beta acids” refers to compounds that can be isolated from hops plant products” (p. 3, lines 16-20), but does not teach a source profile having 35 to 99% non-hydrated beta hops, less than 0.05% hydrogenated hops beta acid, and less than 1% hops alpha acids by weight.
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).
Since the hop acids may be present “between about 0.001 and 0.1%” or “between about 1 and 99%” (Id. lines 18-22), it would have been obvious for the method to comprise an extract source, e.g. Beta Bio 45, having 35% to 99% non-hydrogenated hops, less than 0.05% hydrogenated hops beta acid, and less than 1% hops alpha acids, by weight. Note: Baig et al. (below) teaches embodiments having “HOPS CLEAN BETA BIO (45%)” (p. 14, Table 4b). The hops were added in Baig et al. as a useful botanical (see p. 6, para. [0060]). Accordingly, the artisan would have a reasonable expectation of success with the combination.
In regard to claim 18, the property of reducing biofilm acid is a property of hops beta acids in contact with bacteria in the biofilm. Since the prior art teaches hops beta acids in its method, that property would have been present in the prior art as well.
The compositions include fluoride, but it is not taught to be necessary for the practice of the method (see Beddie, p. 10, claim 1). Thus, it would have been obvious for the method to be free or substantially free of fluoride, as per claims 1 and 8.
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 method only requires use of the antibacterial agents, e.g. hops beta acids. Thus, agents such as silica, alumina, or other non-calcium abrasives, as per claim 7, may be excluded.
The combination of Beddie and Wilson et al does not teach stannous chloride.
Baig et al. teaches, “the oral care compositions herein have improved efficacy for preventing and/or reducing caries and include from about 0.05% to about 1%, by weight of the composition, of metal ions wherein the composition comprises from about 0.05% to about 1%, by weight of the composition, of zinc ions and optionally comprises from about 0.01% to about 1.5%, by weight of the composition, of stannous ions” (tin) (p. 6, para. [0061]). Suitable sources of stannous ions include “stannous chloride” (p. 2, para. [0027]). Baig et al. also teaches embodiments with stannous having “HOPS CLEAN BETA BIO (45%)” (p. 14, Table 4b):
PNG
media_image1.png
608
658
media_image1.png
Greyscale
The hops were added in Baig et al. as a useful botanical (see p. 6, para. [0060]).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to add zinc and/or tin (stannous chloride) to the compositions of Beddie for the advantage of improved efficacy for preventing and/or reducing caries, as taught by Baig et al.
The combination would have provided the claimed property of an anticaries benefit greater than a reference composition having 1,000 ppm of sodium monofluorophosphate, as per claim 11, as well as a 75% or 100% reduction in acid production according to iPGRM method, and a change in pH of less than about 0.4 according to iPGRM method, as per claims 18-20.
Concerning claims 12-14, since hop beta acids have separate utility as antimicrobial agents it would have been obvious to combine metal ion source of Baig et al., e.g. stannous chloride, for the same purpose of treating or preventing caries. Generally, it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose in order to form a third composition that is to be used for the very same purpose; the idea of combining them flows logically from their having been individually taught in prior art. See MPEP 2144.06. Thus, combining beta hops of Beddie with the metal ion source of Baig, to the exclusion of other antimicrobial agents, as claimed in the instant invention would have been prima facie obvious since they are both taught to be useful for treating dental caries.
Concerning claim 15, Baig et al. teaches adding buffering agents to the compositions as “agents that can be used to adjust the pH of the compositions to a range of about pH 3.0 to about pH 10” (p. 5, para. [0049]), as per claims 16-17. Buffering agent are preferably “citric acid, sodium citrate” and may be “used at a level of from about 0.1% to about 30%, preferably from about 1% to about 10%” (p. 4, para. [0050]).
It would have been obvious to a person having ordinary skill in the art to add citric acid and sodium citrate to the compositions and method of Beddie for the advantage of adjusting the pH of the compositions. Further, it is prima facie obvious to select a known material based on its suitability for its intended use (see MPEP 2144.07; “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)”). Also, established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function (see 2144.06).
2) Claim(s) 9-10 remain rejected under 35 U.S.C. 103 as being unpatentable over Beddie (WO2007/012080, cited in IDS) and Krofta et al., (KVASNY PRUM. 60/2014) and further in view of Baig et al., (US 2016/0324741, cited in IDS) as applied to claims 1 above, and further in view of Spirit Dental (www.spiritdental.com; 2019, cited in IDS).
The combination of Beddie, Krofta et al. and Baig et al. does not teach applying the toothpaste composition for at least 1 minute, and expectorating the toothpaste from the oral cavity.
Spirit Dental teaches a method of brushing teeth “for about two minutes per brushing session” (2nd page) and instructions to “rinse out your mouth with some water” (Id.). The “rinse out” step would have involved expectorating the toothpaste as well as not swallowing, as per claim 10.
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s invention to brush for at least 1 minute and expectorate the toothpaste after brushing, since this is recognized in the art as a suitable practice for treating the teeth, as taught by Spirit Dental.
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).
Claims 1, 2, 4-7, 9-14, 16-20 remain 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 methods of contacting the oral cavity with a fluoride free toothpaste 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.
Response to Arguments
i) The Declaration of Dr. Samuel St. John is acknowledged. Affiant postulates, “Our inventive composition provides a synergistic acid inhibition benefit as evidenced by a Hill coefficient of greater than 1.2” (see Declaration filed 12/01/2025) “It is my opinion that the synergistic acid inhibition benefit provided by the combination of hops and stannous in the inventive compositions is not predictable . . . In addition, Sn2+ and hops beta acids form a complex . . . which typically inhibits the activity of one or both materials in the complex. Thus, one would not expect to get a synergistic benefit from a complex involving Sn and hops beta acids.” (p. 3).
However, "A greater than expected result is an evidentiary factor pertinent to the legal conclusion of obviousness ... of the claims at issue." In re Corkill, 771 F.2d 1496, 226 USPQ 1005 (Fed. Cir. 1985). In Corkhill, the claimed combination showed an additive result when a diminished result would have been expected. This result was persuasive of nonobviousness even though the result was equal to that of one component alone. Evidence of a greater than expected result may also be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately (i.e., demonstrating "synergism"). Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). However, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991) (Evidence showing greater than additive sweetness resulting from the claimed mixture of saccharin and L-aspartyl-L-phenylalanine was not sufficient to outweigh the evidence of obviousness because the teachings of the prior art lead to a general expectation of greater than additive sweetening effects when using mixtures of synthetic sweeteners.) (see MPEP 716.02(a).I.).
Affiant has not demonstrated synergy, insofar as it has not been demonstrated what the change efficacy would be compared to stannous chloride and/or hops acid alone.
The Hill coefficient is used to estimate the number of ligand molecules that are required to bind to a receptor to produce a functional effect. Use of Hill to demonstrate synergy would have required a demonstration of an effect which is greater than the sum of each of the effects taken separately, as evidenced by Meyer et al. (Cell System, Feb. 2019), which defines “Synergisitc potency” as “The magnitude of the change in the drug potency, owing to the presence of another drug” and “Synergistic efficacy” as “The percent change in the maximal efficacy of the combination compared to the most efficacious single agent” (see Table 1. Key Definitions at p. 98).
Applicant’s attempt to demonstrate synergy using the Hill Equation is novel and unsupported by the literature. Accordingly, it cannot be said that the person having ordinary skill in the art would reasonably rely an approach that is not well-established.
Stannous and hops acids are both expected to bind to plaque biofilm. Baig et al. teaches, “Due to strong reactivity with saccharolytic organisms, compositions containing high levels of bioavailable stannous produce significant inhibition of plaque acid generation in the i-PGRM assay” (p. 6-7, para. [0067]). Bogdanova et al. (Research in Microbiology, 2018) teaches, in it’s study of the “Antibiofilm activity of bioactive hop compounds’ (Ti.), “All tested hop compounds were shown to possess antimicrobial properties against all tested staphylococci, both planktonic and biofilm-dwelling, with no significant difference between resistant and susceptible strains. All compounds lowered the number of bacterial cells released from the biofilm, with the strongest effect seen for lupulone, followed by xanthohumol. Moreover, lupulone and xanthohumol were not only able to penetrate the biofilm and reduce the number of bacteria within it, but their higher concentration s (~60 ug/mL for xanthohumol and -125 g/mL for lupulone) reduced the number of surviving bacteria cells to zero” (Abstract). Note: lupulone is a hops beta acid.
Even if, Affinant’s data provided evidence of unexpected results, Applicant is required to 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.”). Baig et al. teaches a specific embodiment of a dentifrice comprising stannous fluoride and hops beta acids (see p. 6, para. [0060]). The composition is expected to provide stannous ions had hops beta acids. It may very well be that the synergy seen by Affiant is inherent to compositions comprising hops and stannous ions. Due to the absence of tests comparing applicant's claimed invention with those of the closest prior art, assertions of unexpected results constitute mere argument.
Conclusion
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
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