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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/9/2026 has been entered.
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.
Claim 12 is 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 12 recites the limitation “from about 20 wt% to about 80 wt% of the flavoring agent is released from the at least one flavor glycoside about 20 minutes after the oral product is placed in the oral cavity of the user.” It is not clear if the flavoring agent is released from the at least one flavor glycoside within 20 minutes after the oral product is placed in the oral cavity of the user, or if the flavoring agent is released from the at least one flavor glycoside starting about 20 minutes after the oral product is placed in the oral cavity of the user.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 37 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 37 depends from itself.
. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Response to Arguments
Applicant’s amendments and arguments, filed 2/9/2026, have been fully considered, but they are not convincing.
Applicant argues that Wang includes no disclosure of the rate of release of flavors from flavor glycosides when in the oral cavity of a user. Moreover, there is no suggestion in Wang that flavor glycosides may be used to provide slow and prolonged release of flavors, as now recited in the claims.
The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. >See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”)
Applicant argues that the examples of Wang demonstrate that steviol glycosides are not used to affect the rate of release of a flavoring agent because the tested compositions are in the form of aqueous solutions. Applicant also argues that Wang does not demonstrate or suggest that the steviol glycosides would demonstrate the prolonged release function recited in the claims and provides no disclosure that would direct the skilled person to use flavor glycosides in oral products that are to be held in the oral cavity of a user for a period of at least 5 minutes.
“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Wang et al as modified by Bridges et al renders obvious an oral product having a composition substantially the same as the claimed product. Therefore, where applicant claims a composition or product in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, a rejection is appropriate. In other words, when the structure recited in the reference is substantially identical to that of the claims, the claimed properties or functions are presumed to be present. See Jn re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
As discussed in the rejections, it would have been obvious to one of ordinary skill in the art to form a lozenge, pastille or tablet product comprising claimed components as disclosed by Wang et al in view of Bridges et al. The amount of time the user retains the product in the oral cavity is a personal preference and therefore, selectable by a user. Pharmaceutical products intended to remain in the oral cavity for longer than five minutes are known. See Wolfson (US 2021/0113493), Abs, and [0096] for example.
Regarding Bridges et al, Applicant argues that Bridges includes no disclosure of providing a formulation to provide a slow and prolonged release of flavor from the flavor glycosides over a period of at least 5 minutes. Bridges et al describes the inclusion of rebaudioside B in a steviol glycoside formulation for a different purpose. Bridges’ examples are directed to products that are in the oral cavity only transiently (such as food and drink).
The arguments are similar to those already discussed and the response is the same.
Regarding Aspgren et al, Applicant argues that Aspgren et al describes that “[i]t is generally desirable to provide oral pouched smokeless tobacco products with rapid release of flavor and nicotine to reduce nicotine craving and give an initial strong flavor experience." Applicant further argues that the rapid release of flavor described in Aspgren is opposite of the claimed product recited, which explicitly requires slow release of the flavoring agent.
Aspgren et al addresses a need for oral pouched products that a user can hold in the oral cavity for a period of time of about 15 to 40 minutes and which provide a satisfactory taste experience and nicotine release and avoid a feeling of runniness in the mouth upon use by the user ([0020]-[0022]). Aspgren et al further teaches that 5, 10, 15 or 30 minutes are typical snus usage periods for commercial snus products [0137].
The rejections over the cited prior art are maintained, but have been amended to address the amendments to the claims.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5,7,12,14,16,19-21,31-33 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (US 2019/0289890) in view of Bridges et al (US 10,583,314), and with the evidence of Wolfson (US 2021/0113493) and Merriam Webster Dictionary (definition of lozenge).
Claims 1,3-4, 7 and 12: Wang et al discloses an oral product comprising a flavoring comprising a steviol glycoside (SG) and a glycosylated steviol glycoside (GSG). (Abs.; [0002]). In some embodiments, the steviol glycosides comprise glucose moieties ([0014]-[0015], [0154]-[0158]), which reads on a flavoring agent bound to a sugar via a glycosidic bond. Where the glucose moieties are present, the GSG also is a glucoside.
Exemplary orally consumable compositions include, but are not limited to medicinal compositions and oral hygiene compositions [0341]. The term “medicinal composition” includes solids having medicinal value, such as cough drops (reads on lozenges), chewable medicinal tablets, etc. [0397]. Tablet, lozenge are pastille are synonyms (see Merriam Webster Dictionary, definition of lozenge).
Wang et al does not disclose a filler or bulking agent. In the same field of endeavor, Bridges et al discloses steviol glycoside compounds as sweeteners in consumable compositions such as pharmaceutical compositions and medicinal compositions (e.g., tablets, lozenges, etc.) (Abs, col 1; line 55 to col 2, line 3; col 8, lines 2-45).
In some embodiments, the compositions comprise bulking agents to deliver products with controlled sweetness, dosing, potency, and handling properties. (col 3, lines 42-46). Bulking agents also read on fillers.
Absent convincing evidence of unexpected results commensurate in scope with the claims, it would have been obvious to one of ordinary skill in the art to include a bulking agent of Bridges et al in the composition of Wang et al and to form a lozenge, pastille or tablet product comprising claimed components as disclosed by Wang et al to obtain products with controlled sweetness, dosing, potency, and handling properties with a reasonable expectation of success in forming a suitable oral product.
The product of Wang et al as modified by Bridges et al is substantially identical to the claimed oral product. Where applicant claims a composition or product in terms of a function, property or characteristic and the structure or composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, a rejection is appropriate. In other words, when the structure recited in the reference is substantially identical to that of the claims, the claimed properties or functions (rate of release of flavoring agent from the steviol glycosides) are presumed to be present. See Jn re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Although tobacco products are mentioned, tobacco is not a required ingredient, therefore a product comprising no tobacco (tobacco-free) is embodied.
The amount of time the user retains the product in the oral cavity is a personal preference selectable by a user.
Claim 2: The GSGs are produced by an enzymatic process ([0051], [0401]), which reads on a biotechnological process.
Claim 5: Steviol is a diterpene flavorant [0157].
Claims 14 and 16; Additional additives disclosed by Wang et al include bitter agents such as caffeine ([0258], [0293]); organic acids such as taurine ([0258], [0283]); vitamins such as B6, B12, C ([0258], [0305], [0326]); melatonin ([0258], [0305]), all of which are claimed active ingredients. Absent convincing evidence of unexpected results commensurate in scope with the claims, it would have been obvious to one of ordinary skill in the art to form a chewing product comprising claimed components with a reasonable expectation of success in forming a suitable oral product.
Claim 19: Wang et al does not disclose nicotine as an ingredient, therefore a nicotine-free product is embodied.
Claim 20: The SGs and GSGs are present individually or collectively in an amount of about 0.1 wt % to about 99.5 wt %, including any range specified by any combination of integers from 1 to 99 [0191], which overlays the claimed range. Absent convincing evidence of unexpected results commensurate in scope with the claims, it would have been obvious to one of ordinary skill in the art to form an oral product comprising claimed amounts of the flavor glycosides with a reasonable expectation of success in forming a suitable oral product.
Claim 21: In some embodiments, Wang et al disclosed that the oral product comprises additional flavoring agents that are different from the flavoring agent in the flavoring steviol glycosides SGs and GSGs.([0272]-[0273]). The product of Wang et al is substantially identical to the claimed oral product and will exhibit the claimed relative rates of release of the flavoring agents and flavor glycoside because, where applicant claims a composition or product in terms of a function, property or characteristic and the structure or composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, a rejection is appropriate. In other words, when the structure recited in the reference is substantially identical to that of the claims, the claimed properties or functions are presumed to be present. See Jn re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Claim 31: A package containing the oral product would have been obvious in order to protect the product, ship the product to a seller and/or display it for sale in a retail store.
Claim 32: Wang et al discloses that all of the starting components of the composition disclosed herein can be purchased or be made by processes known to those of ordinary skill in the art and combined (e.g., precipitation/co-precipitation, mixing, blending, grounding, mortar and pestle, microemulsion, solvothermal, sonochemical, etc.) or treated as defined by the present application [0233]. The disclosed method embodies providing at least one filler or bulking agent and at least one flavor glycoside, and contacting the at least one filler or bulking agent and at least one flavor glycoside to form the product.
Claim 33: Wang et al discloses an oral product substantially identical to the claimed oral product and which is intended to be taken into and contacted with the mouth of a user ([0340]-[0341]), and a soluble portion dissipates with a portion of the flavoring agent over a period of time during chewing while the insoluble gum base portion is retained in the mouth. As discussed above, the amount of time the user retains the product in the oral cavity is a matter of personal preference. The claimed flavor delivery period of at least ten minutes will be obtained or, at least, would have been obvious for reasons previously given.
Claim 35-: Wang et al discloses that the oral product comprises in some embodiments additional flavoring agents that are different from the flavoring agent in the flavoring steviol glycosides SGs and GSGs.([0272]-[0273]). The product of Wang et al as modified by Bridges et al is substantially identical to the claimed oral product and will exhibit the claimed relative rates of release of the flavoring agents and flavor glycoside because, where applicant claims a composition or product in terms of a function, property or characteristic and the structure or composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, a rejection is appropriate. In other words, when the structure recited in the reference is substantially identical to that of the claims, the claimed properties or functions are presumed to be present. See Jn re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Claims 1,7,8,14,16,19,25 and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al in view of Bridges et al (US 10,583,314) and further in view of Aspgren et al (US 2018/0140007) and with the evidence of Merriam Webster Dictionary (definition of lozenge)..
The disclosure of Wang et al in view of Bridges et al has been discussed. In another embodiment, Wang et al discloses that the oral products include smokeless tobacco, snuff [0352]. Wang et al in view of Bridges et al does not disclose a pouched oral product or that the filler or bulking agent comprises at least one cellulose material.
Aspgren et al addresses a need for oral pouched products that a user can hold in the oral cavity for a period of time of about 15 to 40 minutes and which provide a satisfactory taste experience and nicotine release and avoid a feeling of runniness in the mouth upon use by the user ([0020]-[0022]). Aspgren et al further teaches that 5, 10, 15 or 30 minutes are typical usage periods for commercial snus products [0137].
Aspgren et al teaches that moist snuff for oral use is available in loose form or portion-packed in in a saliva-permeable, porous wrapper material forming a pouch (Abs;, [0005]-[0006]). The loose form can be granulated or a powder (corresponds to a solid in loose powder form) [0058].
Aspgren et al discloses an oral pouched snuff product comprising a pouch filling material, or filler, enclosed by the saliva-permeable, porous wrapper material forming a pouch ([0001], [0023]). In some embodiments, the product is tobacco-free and comprises non-tobacco plant fibers as a filler, such as maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buck wheat fibers, potato fibers, apple fibers, cocoa fibers, bamboo fibers and citrus fibers. ([0042], [0053]-[0055]), which include claimed cellulosic material. The fibers are present in an amount from about 1 to about 60% based on the total weight of the smokeless composition [0063], which overlays the claimed range. The filling material can also comprise microcrystalline cellulose [0056]. Absent convincing evidence of unexpected results commensurate in scope with the claims, it would have been obvious to one of ordinary skill in the art to select claimed flavorant of SGs and/or GSGs and a filler or bulking agent containing cellulosic fibers, and to form a pouched oral product comprising a saliva-permeable pouch with the claimed oral product incorporated within the pouch in view of Aspgren et al, and to have a reasonable expectation of success in obtaining a suitable oral product.
The product can comprise nicotine (claimed active agent) or be nicotine free ([0041]-[0042]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS R CORDRAY whose telephone number is (571)272-8244. The examiner can normally be reached Monday-Friday 8 AM-5 PM (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Abbas Rashid can be reached at (571) 270-7457. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DENNIS R CORDRAY/Primary Examiner, Art Unit 1748