DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Terminal Disclaimer
The terminal disclaimer, filed on 23 July 2025, disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on Application No. 18/571,254 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Amendments
Status of Claims
The amendment, filed on 23 July 2025, is acknowledged.
Claims 1-3, 6, 13-15, 20, and 22 have been amended.
Claims 1-3, 6-20, and 22 are pending and under consideration in the instant Office Action.
Objections Withdrawn
Objections to Claims
Applicant’s amendment to claims 1-2, 6, and 22, submitted on 23 July 2025, have overcome the objections to the claims set forth in the Office Action mailed on 23 April 2025. Accordingly, the relevant objections are withdrawn.
Rejections Withdrawn
Rejections pursuant to 35 U.S.C. § 112
The rejection of claim 3 under 35 U.S.C. § 112 is withdrawn in view of Applicant’s amendment, submitted on 23 July 2025. Accordingly, the relevant rejection is withdrawn.
Rejections pursuant to 35 U.S.C. § 103
The rejections of claims 1-3, 6-20, and 22 under 35 U.S.C. § 103 are withdrawn in view of Applicant’s amendments and in favor of the rejections below.
Double patenting rejection
The provisional nonstatutory double patenting rejection of claims 1-3, 6-20 and 22 over claims 1, 3, 6, 9, 13, 15-17 and 21-23 of copending Application No. 18/571,254 in view of Kohli (U.S. Patent Application Publication No. US 2010/0322873 A1, published on December 23, 2010), Dodds (U.S. Patent Application Publication No. US 2010/0040564 A1, published on February 18, 2010), Taheri (Herbs in dentistry. /nt. Dental J. 2011, 67, 287.), and He (Chinese Patent Application Publication No. CN 107213079 A, published on September 29, 2017) is withdrawn in view of the approved terminal disclaimer, filed on 23 July 2025.
Maintained Objections
Claims
Applicant is again advised that should claim 15 be found allowable, claim 20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
New Grounds of Rejection
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.
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 nonobviousness.
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, 6-10, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Barkalow et al. (U.S. Patent Application Publication No. US 2018/0271112 A1, published on 27 September 2018, hereafter referred to as Barkalow) in view of Dodds et al. (U.S. Patent Application Publication No. US 2010/0040564 A1, published on 18 February 2010, hereafter referred to as Dodds) and Kohli et al. (U.S. Patent Application Publication No. US 2010/0322873 A1, published on 23 December 2010, hereafter referred to as Kohli).
Barkalow teaches low calorie, low laxation confections such as chewy candy or gelled candy which contain a bulk sweetener comprising allulose (psicose) (Abstract). To produce confections that possess acceptable texture, flavor, and shelf-life while being less caloric and avoiding gastrointestinal disturbances, Barkalow teaches the use of allulose (psicose) as a sweetener, alongside other substances (para. [0011-0014]). Allulose is taught to be a beneficial alternative sweetener because, though similar to sucrose, “it may not be cariogenic and is non-caloric, nor does it cause significant gastro-intestinal disturbances, giving a highly consumer-acceptable confectionary product” (para. [0015]). Due to these properties, allulose is taught to be capable or replacing some or all of sucrose as a bulk sweetening agent in confections (para. [0057-0058]).
Allulose is also taught to be capable of being used alone or in combination with other sugars such as tagatose, trehalose, and/or isomaltulose (para. [0026]). Isomaltulose is taught to be an advantageous alternative sweetener because it produces a “lower glycemic response than sucrose making it acceptable to diabetics”, as well as being tooth friendly and not producing carries (para. [0029]). Trehalose is also taught to be an advantageous alternative sweetener due to its high resistance to acid hydrolysis and non-cariogenic properties (para. [0030]).
The confections are taught to be in several forms, including gelled confections, which are sometimes called gummies, jellies, or gum drops, and which have a firm, elastic texture that are often chewed and dissolve in the mouth (para. [0041]). The gelled confections are interpreted as being equivalent to the semi-solid chewable compositions recited in the instant application and the gummy composition recited in instant claim 3. Gelled confections are taught to require at least one gelling agent, which may be gelatin, pectin, starch, or others (para. [0046]).
Amended claim 3 recites the semi-solid chewable composition “consists essentially of” three low glycemic index sugars. MPEP § 2111.03.III. provides guidance on the transitional phrase “consists essentially of”, stating “For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355. Therefore, the composition recited in amended claim 3 is treated as comprising psicose, isomaltulose, and sorbose, tagatose, or trehalose.
Barkalow does not teach their compositions to comprise an herbal composition, an amino acid, a vitamin, a pH buffer, or a non-dissolvable component, nor the pH of the composition. These deficiencies are offset by the teachings of Dodds and Kohli.
Dodds teaches “an oral composition for oral cleaning, breath freshening, and anti-microbial benefits” (Abstract). The health benefits of the composition, including cleaning of the oral cavity and antimicrobial effects, are taught to arise from green tea extracts, Oolong tea extracts, licorice, and Magnolia Bark Extract (para. [0031] and Table 1). Other components of the compositions taught by Dodds include a pH control agent, such as a buffer, vitamins, and minerals (para. [0099]).
Dodds further teaches their oral composition to be capable of being configured to dissolve in the oral cavity or not to dissolve. In the case of the former, Dodds refers to the configuration as an “edible film formulation” and teaches “the highly dissolvable edible film can act as a medium through which a pharmaceutically active oral agent can be administered via a mucous membrane of the oral cavity” (para. [0092]). The edible films comprise hydrocolloids, which in some embodiments may be gelatin, starch, carrageenan, gum arabic, agar, and/or pectin (para. [0090] and [0096]). In the configuration of a “chewing gum formulation”, the composition is taught to comprise “a water-soluble bulk portion, a water-insoluble chewable gum base portion and typically water-soluble flavoring agents” (para. [0061] and claim 20). The water-insoluble chewable gum base may comprise the hydrophobic materials elastomers, resins, fillers, and/or wax (para. [0062]). The compositions are also taught to comprise cellulose polymers to aid with texture (para. [0068]), mint oils as flavoring agents, which is considered equivalent to mentha, (para. [0078]), and polyethylene glycol and glycerin as softeners (para. [0101]).
Kohli teaches a beverage comprising arginine which is stated to promote oral health rather than damage it as soft drinks and sport drinks do (Background). The beverage is taught to comprise basic amino acids, “not only naturally occurring basic amino acids, such as arginine, lysine, and histidine, but also any basic amino acids having a carboxyl group and an amino group in the molecule” (para. [0040]). In certain embodiments, arginine is included in the beverage in free or salt form, in an amount of >0.1% w/w, in addition to a calcium salt, ions, and other ingredients (claims 1-4). One of the additional ingredients is a vitamin, which may be B-complex vitamins or ascorbic acid (vitamin C) (para. [0020]). Kohli teaches that the beverage can “reduce or inhibit formation of dental caries, reduce, repair or inhibit early enamel lesions, and reduce or inhibit demineralization and promote remineralization of the teeth” (para. [0023-0025]). In Formula A, Kohli teaches a composition that comprises arginine at the amount 0.5% w/w, and in Formula B the amount of arginine is 0.6% w/w (Example 1).
Guidelines on the obviousness of similar and overlapping ranges, amounts, and proportions are provided in MPEP § 2144.05. With respect to claimed ranges which “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). These guidelines apply to the quantity of arginine recited in instant claims 1 and 6. In each instance, the teachings of Kohli either fall within the arginine concentration range recited or encompass the range recited, rendering them prima facie obvious.
Finally, Kohli teaches that even diet sodas, which typically have less sugar than other sodas, can be damaging to oral health because of their high acidity (Abstract). Oral care products can produce higher plaque pH, protecting teeth against acidic drinks, by containing arginine (para. [0004]). The invention claimed by Kohli is taught to require a pH of at least 5.5 (claim 14).
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to combine the teachings of Dodds and Kohli with the confection compositions taught by Barkalow to arrive at the claimed invention because combining prior art elements according to known methods to impart known benefits yields predictable results. In view of the teachings of Dodds, the ordinary artisan would be motivated to include the herbal extracts, vitamins, buffers, and minerals in the compositions of Barkalow because Dodds teaches these components to aid oral health by cleaning and imparting anti-microbial effects. Barkalow teaches that consideration must be given to oral health, in particular the creation of caries, but does not teach the inclusion of additional agents to address the issue outside of non-cariogenic sweeteners. It would be obvious to one of ordinary skill that inclusion of the components taught by Dodds could improve the impact on oral health from the compositions of Barkalow.
A person of ordinary skill would further be motivated to modify the teachings of Barkalow and Dodds with those of Kholi because, while Dodds taught the inclusion of vitamins and pH control agents, they did not teach a specific vitamin to include in their oral health composition nor a specific pH value. Kohli provided examples of vitamins to be used as well as a minimum pH to improve oral health. Further, Kohli taught the utility of including amino acids, in particular arginine, in oral health compositions, which would motivate one of ordinary skill in the art to include arginine in the invention rendered obvious by the teachings of Barkalow and Dodds to improve the impact on oral health.
While Kohli teaches a beverage rather than a semi-solid composition as taught by Barkalow and Dodds, both references teach the bulk of their compositions to be water-soluble, indicating they would be consumed by a user (para. [0061] and claim 20). In the context of the edible film of Dodds, which is formulated to fully dissolve and be ingested, Dodds stated “the highly dissolvable edible film can act as a medium through which a pharmaceutically active oral agent can be administered via a mucous membrane of the oral cavity” (para. [0092]). Because the inventions of Dodds and Kohli delivery the majority of their components for oral health as water-soluble components in a water carrier, they are considered analogous. As a result, there is a reasonable expectation of success in arriving at the invention of claims 1-3, 6-10, and 16 in view of the teachings of Dodds and Kohli.
Claims 11-15 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Barkalow (U.S. Patent Application Publication No. US 2018/0271112 A1, published on 27 September 2018) in view of Dodds (U.S. Patent Application Publication No. US 2010/0040564 A1, published on 18 February 2010) and Kohli (U.S. Patent Application Publication No. US 2010/0322873 A1, published on 23 December 2010) as applied to claims 1-3, 6-10, and 16 above, and further in view of Cai et al. (U.S. Patent Application Publication No. US 2010/0104518 A1, published on 29 April 2010, hereafter referred to as Cai) and Zhai et al. (J. Ethnopharmacol. 2016, 194, 153., hereafter referred to as Zhai).
Barkalow, Dodds, and Kohli teach the above and particularly relevant to claims 11-15 and 17-20, Dodds teaches the inclusion of some herbs and/or herbal extracts to improve oral health.
Barkalow, Dodds and Kohli do not teach the inclusion of the specific herbs in instant claims 11-15 and 17-20 in their inventions. These deficiencies are offset by the teachings of Cai and Zhai.
Cai teaches a method for producing a chewing gum comprising Chinese medicine as an active agent(s), either encapsulated for controlled release, as a coating on the chewing gum, or in a liquid center (Abstract). Medicaments delivered via chewing gum are taught to display improved absorption of drugs by users, as compared to other methods of delivery, and subsequently improved bioavailability within the user’s system (para. [0018]). Traditional Chinese medicines (TCMs) and their extracts are taught to be beneficial due to their wide applicability, such as digestion aids, oral care, and breath freshening, and may be delivered in chewing gum by comprising a portion of the chewing gum composition (para. [0009] and [0023]). Examples of Chinese medicines that may be included in the invention of Cai include:
shinyleaf pricklyash, the common name of Zanthoxylum nitidum (para. [0033] and Tables A and B);
dandelion (Pu-gong-yin), which is taught to reduce internal heat and detoxify (para. [0025] and [0077]);
Isatis tinctoria, another name for Radix Isatidis, (para. [0035] and Tables A and B);
Scutellaria baicalensis, (para. [0036] and Tables A and B);
honeysuckle (Jing-yin-hua), which is taught to have antibacterial properties (para. [0030] and [0259], Examples 230-237, and claim 69);
Forsythia (para. [0036] and Tables A and B);
chrysanthemum, which is taught to have anti-bacterial properties (para. [0030-0032] and [0034-0035], Tables A and B, and claims 69 and 77);
chamomile (para. [0082]); and
Phellodendron amurense, otherwise known as Cortex phellodendri or Huang-bai (para. [0035] and Tables A and B).
To demonstrate particular utility in chewing gum and treating oral health, many of the TCMs above were tested for their ability to inhibit the growth of and/or kill bacteria present in the human mouth (para. [0078-0080] and Tables A and B). Many of the TCMs listed above were taught to exhibit bactericidal activity against P. gingivalis, F. nucleatum, and S. mutans. at relatively low concentrations of ~5-10 mg/mL or less (Tables A and B).
Zhai teaches the attenuation of inflammatory response by Corydalis bungeana (Abstract). C. bungeana is taught to be “one of the most traditionally used medicines in China and is widely used for the treatment of cold, fever, throat swelling, etc.” (pg. 154, left column, para. 3). The traditional Chinese medicine is taught to be useful for these applications due to its anti-inflammatory and antibacterial properties, as well as having use as an anti-cancer agent (pg. 154, left column, para. 3). The source of these properties is taught to be alkaloids, several of which (corynoline, acetylcorynoline, and protopine) are capable of down-regulating several pro-inflammatory cytokines (pg. 154, right column, para. 2).
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to modify the invention rendered obvious by the teachings of Barkalow, Dodds, and Kohli with the teachings of Cai and Zhai to arrive at the invention of claims 11-15 and 17-20 because combining prior art elements in a known method to gain known benefits yields predictable results. One would be motivated to modify the invention rendered obvious by Barkalow, Dodds, and Kohli because, while Dodds taught the use of herbs in their oral composition, only a select few specific examples were disclosed. Cai teaches the specific utility of many traditional Chinese medicine herbs and herbal extracts in the context of oral health, in particular during use in a chewable composition, and reported their antibacterial activity against three strains of bacteria found in the human oral cavity and associated with oral disease. In view of the teachings of Zhai, an ordinary artisan would further be motivated to use C. bungeana in the invention rendered obvious above because Zhai teaches the herb to be one of most widely used traditional Chinese medicines, demonstrating its safe administration to humans, and to have anti-inflammatory and antibacterial properties. One of ordinary skill would recognize that a widely used traditional Chinese medicine with anti-inflammatory and antibacterial properties would be beneficial in a chewable composition intended to treat oral health. As a result, there is a reasonable expectation of success in arriving at the invention of instant claims 11-15 and 17-20 in view of the teachings of Barkalow, Dodds, and Kohli and further in view of the teachings of Cai and Zhai.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Barkalow (U.S. Patent Application Publication No. US 2018/0271112 A1, published on 27 September 2018) in view of Dodds (U.S. Patent Application Publication No. US 2010/0040564 A1, published on 18 February 2010) and Kohli (U.S. Patent Application Publication No. US 2010/0322873 A1, published on 23 December 2010) as applied to claims 1-3, 6-10, and 16 above, and further in view of Jung et al. (J. Ethnopharmacol. 2009, 122, 313., hereafter referred to as Jung).
Barkalow, Dodds, and Kohli teach the above and particularly relevant to claim 22, Dodds teaches the inclusion of some herbs and/or herbal extracts to improve oral health.
Barkalow, Dodds and Kohli do not teach the inclusion of the herb notoginseng. This deficiency is offset by the teachings of Jung.
Jung teaches the anti-inflammatory properties of Panax notoginseng root and flowers (Abstract). A rising interest in traditional herbal medicines is taught to be occurring, leading to increased attention on their safety and efficacy (pg. 313, right column, final para. - pg. 314, left column, para. 1). P. notoginseng is taught to be a common treatment for chronic liver disease due to its ability to stop internal hemorrhaging, as well as a treatment for trauma and bleeding, immunomodulation, and to treat cancer (pg. 314, left column, para. 1). However, these effects are traditionally associated with the root of the plant and the properties of its flower were previously poorly understood (pg. 314, left column, para. 1). Extracts of the notoginseng flower in methanol are taught to have strong anti-inflammatory properties, implying that the extract “may be a potential drug for treating inflammatory diseases” (pg. 318, Conclusion and Abstract).
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to modify the invention rendered obvious by the teachings of Barkalow, Dodds, and Kohli with the teachings of Jung to arrive at the invention of claim 22 because combining prior art elements in a known method to gain known benefits yields predictable results. One would be motivated to modify the invention rendered obvious by Barkalow, Dodds, and Kohli because, while Dodds taught the use of herbs in their oral composition, only a select few specific examples were disclosed. Jung teaches that P. notoginseng is a widely used traditional Chinese medicine, demonstrating its safe administration to humans, and has anti-inflammatory, hemorrhage-stopping, and anticancer properties. One of ordinary skill would recognize that a widely used traditional Chinese medicine with anti-inflammatory properties would be beneficial in a chewable composition intended to treat oral health, in addition to having properties that would benefit the user in the rest of their body. As a result, there is a reasonable expectation of success in arriving at the invention of instant claim 22 in view of the teachings of Barkalow, Dodds, and Kohli and further in view of the teachings of Jung.
Response to Arguments
The Applicant’s arguments, filed on 23 July 2025, have been fully considered but are not persuasive.
Applicant argues in para. 2-3 of Claim Rejections – 35 USC § 103 on pg. 1 of the remarks filed on 23 July 2025, that none of the references cited in the previous Office Action taught the combination of low glycemic index sugars. This argument is now considered moot in view of the new grounds of rejection provided above. In para. 4 of Claim Rejections – 35 USC § 103 on pg. 1, Applicant argued that the references also did not teach the specific herb notoginseng. This has been addressed above in the new grounds of rejection.
In para. 1-2 of Dependent Claims 10-15 and 17-20 of pg. 2, Applicant states that the combined references of Taheri et al. (Int. Dental J. 2011, 61, 287.) and He (Chinese Patent Application Publication No. CN 107213079 A) do not “cure the defect of the combined teaching of Taheri and He”. This self-reference is believed to be a mistake and instead should be referring to the alleged defects in the three combined references previously used in the rejection of claims 1-3, 6-9, 16, and 22 under 35 U.S.C. § 103 presented in the Office Action mailed on 23 April 2025. In view of the new grounds of rejection in view of Barkalow, Dodds, and Kohli (vide supra), this argument is also considered moot. Finally, Applicant argues in para. 3 of Dependent Claims 10-15 and 17-20 of pg. 2 that the amended lists of herbal compositions renders instant claims 13-15 non-obvious in view of the prior art. The Examiner respectfully disagrees in view of the new grounds of rejection provided above.
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 Sean J. Steinke, whose telephone number is (571) 272-3396. The examiner can normally be reached Monday - Friday, 09:00 - 17:00 ET.
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/S.J.S./
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619