FINAL 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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/02/2025, 10/09/2025, 10/29/2025, 11/12/2025, 11/21/2025, 12/05/2025, 12/12/2025, 01/07/2026 (2), 01/15/2026, 02/17/2026, 02/26/2026, and 03/09/2026 have been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action.
Status of the Claims
This action is in response to papers filed 02/02/2026 in which claims 8 and 19-21 were canceled; and claim 1 was amended. All the amendments have been thoroughly reviewed and entered.
Claims 1-7 and 9-18 are under examination.
Withdrawn Objections/Rejections
The Examiner has re-weighted all the evidence of record. Any rejection and/or objection not specifically addressed below is hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Maintained Rejection
Claim Rejections - 35 USC § 112 – NEW MATTER
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7 and 9-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 introduces new matter as the claim recites the limitation: the outer coating layer being free of nicotine and nicotine derivative. There is no support in the specification for the outer coating to be free of nicotine and nicotine derivative.
Applicant asserted that support for the amendments can be found in at least paragraphs [0270], [0286], [0299], and [0319] of the original specification, and in FIG. 21 of the original drawings.
However, a thorough review of said paragraphs [0270], [0286], [0299], and [0319], and FIG. 21, as well as, throughout the specification, there is no support for the outer coating to be free of nicotine and nicotine derivative. It is noted that while paragraph [0320] of the original specification positively recites in alternative elements that the coating may be configured to provide “nicotine or a nicotine derivative and or an additive (e.g., flavorant and/or sweetener) ….,” paragraph [0320] only provide support for excluding the positively recited alternative element of “nicotine or a nicotine derivative” from the coating, and not “nicotine and nicotine derivative.” There is no support in original specification for excluding nicotine AND nicotine derivative from the coating.
Claims 2-7 and 9-18 are also rejected as they are dependent directly or indirectly from rejected base claim 1, respectively, thereby also contains the conflicting new matter material.
Therefore, it is the Examiner’s position that the disclosure does not reasonably convey that the inventor had possession of the subject matter of the amendment at the time of filing of the instant application.
Response to Arguments
Applicant's arguments filed 02/02/2026 have been fully considered but they are not persuasive.
Applicant argues:
“paragraph [0299] is not limiting as to the structure or arrangement of the layer and therefore does not preclude applicability to an outer coating layer. Moreover, other portions of the original specification make clear that nicotine and/or nicotine derivative are not required in the coating. For example: "In at least one example embodiment, the coating 5404 may be configured to provide nicotine or a nicotine derivative and/or an additive (e.g., flavorant and/or sweetener) over a different time period than the body 5402 .... the coating 5404 may be configured to provide an initial burst of nicotine or the additive" Id. 1 [0320] (emphasis added). Lastly, even if the layer disclosed in paragraph [0299] did not explicitly support a coating layer, which the Applicant does not concede, the original specification expressly discloses the combination of features from different embodiments, for example, "[a]lthough described with reference to specific examples and drawings, modifications, additions and substitutions of example embodiments may be variously made according to the description by those of ordinary skill in the art." Id. 1 [0377] (emphasis added).” (Remarks, page 8).
In response, the Examiner disagrees. There is no indication in paragraph [0299] the “layers” pertains to a coating layer surrounding the chewing gum. Rather, it is quite clear in paragraph [0299] that the “layers” pertains to a multilayer chewing gum in which the chewing gum itself can have and be constructed in a multilayer form. This is evident by the disclosure in paragraph [0299] in which it discloses “the layers may have different amounts of “chewing gum polymers (PVA), polysaccharide, and/or oil …,” which pertains to the gum base. Thus, there is no support in paragraph [0299] for “the outer layer being free of nicotine and nicotine derivatives” as claimed.
With respect to paragraph [0320] of the specification as cited by Applicant, as discussed in the pending New Matter rejection, it is reiterated while paragraph [0320] of the original specification positively recites in alternative elements that the coating may be configured to provide “nicotine or a nicotine derivative and or an additive (e.g., flavorant and/or sweetener) ….,” paragraph [0320] only provide support for excluding the positively recited alternative element of “nicotine or a nicotine derivative” from the coating, and not “nicotine and nicotine derivative.” There is no support in original specification for excluding nicotine AND nicotine derivative from the coating.
With respect to paragraph [0377] of the specification as cited by Applicant, there nothing in paragraph [0377] that relates or pertains to providing disclosure for claimed “the outer layer being free of nicotine and nicotine derivatives,” as nothing in the prior paragraphs of the disclosure provided Applicant possession of the claimed “the outer layer being free of nicotine and nicotine derivatives.”
Accordingly, for at least the reasons discussed above and of record, it is maintain that it is the Examiner’s position that the disclosure does not reasonably convey that the inventor had possession of the subject matter of “the outer layer being free of nicotine and nicotine derivatives” at the time of filing of the instant application
New Rejection
Necessitated by Applicant’s Claim Amendments
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.
Claim(s) 1-7 and 9-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urnezis et al (US 6,350,480 B1) in view of Neergaard (US 2018/0295856 A1) and Gao et al (EP 3622834 A1).
Regarding claim 1, Urnezis teaches a chewing gum comprising a gum base core containing polyvinyl acetate (PVA) as the gum base polymer, triglyceride and triacetin (Abstract; column 1, lines 64-end; columns 2-6; columns 11-12; Examples 1-5; claims 1-5 and 10-24). Urnezis teaches the chewing gum further comprises a lipophilic active agent (column 3). Urnezis teaches the lipophilic active agent is part of the gum base core (Abstract; claim 23). Urnezis teaches the triglyceride is present in an amount of from about 6% to 14% by weight and triacetin (glycerol triacetate) is present in an amount from about 6% to 10% by weight (column 5, lines 45-end; column 6, lines 1-7; Examples 1-5). Urnezis teaches the polyvinyl acetate is present in an amount of from about 20% to 90% by weight of the gum base, wherein the gum base is present in the chewing gum in an amount of 5% to about 95% by weight of the chewing gum (column 2, lines 10-20; column 5, lines 9-45; Examples 1-5; claim 1). Urnezis teaches the chewing gum further containing flavoring oil in amount of from about 0.2% to about 5% by weight of the chewing gum (column 6, lines 46-56). Urnezis teaches the chewing gum is coated with coating layer containing an active agent (columns 2-4; claims 10-12, 23 and 25). Urnezis does not indicate that the active agent in the coating layer is nicotine, thereby the coating layer of Urnezis is free of nicotine and nicotine derivatives. Urnezis teaches the gum base core further contains a filler such as cellulose polymers in an amount from about 4% to about 50% by weight (column 5, lines 38-50; claims 1 and 5).
While Urnezis does not particularly teach the lipophilic active agent in the gum base core is nicotine, as well as, does not teach the microcrystalline cellulose, it would have been obvious to include nicotine as the lipophilic active agent and microcrystalline cellulose in the gum base core of Urnezis in view of the guidance from Neergaard.
Neergaard teaches a coated chewing gum comprising a chewing gum core (a uniform body) containing polyvinyl acetate (PVA), wherein the polyvinyl acetate is present in amount of 20% to 95% by weight (Abstract; [0001], [0006], [0008], [0014]-[0016], [0019]-[0026], [0029]-[0031], [0041][0048], [0051]-[0060], [0063]-[0078], [0081]-[0095], [0111]-[0128], [0136]-[0152], [0181]-[0213], [0222]-[0241]; claims 1, 5-6, 14-15, 33, and 80). Neergaard teaches the chewing gum core contain plasticizers comprising triacetin and medium chain triglycerides, wherein the plasticizers is in an amount in range of 0.1% to 25% by weight ([0084]-[0090]). Neergaard teaches the chewing gum core contain nicotine as an active pharmaceutical ingredient (Abstract; [0001], [0006], [0008], [0014]-[0016], [0019]-[0026], [0029]-[0031], [0041][0048], [0051]-[0060], [0063]-[0078], [0081]-[0095], [0111]-[0128], [0136]-[0152], [0181]-[0213], [0222]-[0241]; claims 1, 5-6, 14-15, 33, and 80). Neergaard teaches the nicotine is absorbed in carrier such as microcrystalline cellulose (Abstract; [0001], [0006], [0008], [0014]-[0016], [0019]-[0026], [0029]-[0031], [0041][0048], [0051]-[0060], [0063]-[0078], [0081]-[0095], [0111]-[0128], [0136]-[0152], [0181]-[0213], [0222]-[0241]; claims 1, 5-6, 14-15, 33, and 80). Neergaard the chewing gum core contains microcrystalline cellulose in an amount of 5-45% by weight ([0024], [0052]-[0055], [0060] and [0075]-[0076]). Neergaard teaches the dosage amount of nicotine in the chewing gum core is at a dosage amount of 0.5-8 mg, preferably 1-5 mg ([0047]-[0048] and [0118]). Neergaard teaches the nicotine chewing gum core coated with an outer coating that is hard coating or a soft coating ([0161] and [0209]). Nowhere in Neergaard does it indicate that the outer coating contains nicotine, thereby the outer coating of Neergaard is free of nicotine and nicotine derivative.
As evidenced by Gao, it is well-established in the prior art that the nicotine of Neergaard would be dissolved in the triglyceride, as triglyceride also functions as a diluent for nicotine when used in formulating oral products such as chewing gums (Abstract; [0002]-[0004], [0011], [0015]-[0019], and [0035]). Furthermore, as evidenced by Gao, nicotine is a known lipophilic active agent (Gao: [0003] and [0004]).
It would have been obvious to one of ordinary skill in the art to include nicotine as the lipophilic active agent, as well as, microcrystalline cellulose in the gum base core of Urnezis, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Urnezis and Neergaard are commonly drawn coated chewing gum products comprising a gum base core containing polyvinyl acetate (PVA), and a pharmaceutical active ingredient, and Neergaard provided the guidance for including nicotine as the lipophilic active agent in the chewing gum of Urnezis, as nicotine is a lipophilic active agent (as evidenced by Gao supra) and the nicotine is particularly known to be a suitable active agent commonly added in chewing gum products per Neergaard ([0025]-[0048] and [0167]-[0169]; claim 66). Furthermore, Neergaard further established that microcrystalline cellulose is added in the gum core such that microcrystalline cellulose also served as a carrier to which nicotine is absorbed therein so as provide a stabilized nicotine in the chewing gum product per Gao (Neergaard: [0008], [0019] and claim 1; Gao: Abstract, [0005]-[0010], [0014] and [0023]-[0025]). Neergaard further indicated that the incorporation of pharmaceutical active agent such as nicotine in the gum base core containing polyvinyl acetate provides a chewing gum product that has improved release properties of the pharmaceutical active agent from the chewing gum (Neergaard: [0014]-[0016]). One of ordinary skill in the art would have reasonable expectation of success in including nicotine as the lipophilic active agent, as well as, microcrystalline cellulose in the gum base core of Urnezis because it was indicated Urnezis that any lipophilic active agent is suitable as the active agent incorporated in the gum base core including nicotine (Urnezis: Abstract; column 3; claim 23), as well as, Urnezis also indicated that cellulose polymers are one of the suitable materials for use as the fillers in the chewing gum product (Urnezis: column 5, lines 38-50; claim 5). Thus, an ordinary artisan seeking to produce a coated chewing gum product of nicotine that is stabilized and has improved release properties of nicotine from the chewing gum, would have looked to include nicotine as the lipophilic active agent, as well as, microcrystalline cellulose in the gum base core of Urnezis, per guidance from Neergaard and Gao supra, and achieve Applicant’s claimed invention with reasonable expectation of success.
It would also have been obvious to one of ordinary skill in the art to include and optimize the dosage amount of nicotine included in the gum base core of Urnezis to the dosage amount ranging from 2 mg to 8 mg, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because as discussed above, Neergaard provided the guidance to do so by teaching that the effective dosage amount of nicotine included in the gum base core is 0.5-8 mg, and preferably 1-5 mg, which is a dosage range that substantially overlaps the claimed dosage range of from 2 mg to 8 mg. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when 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 similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the dosage amount of nicotine added in the uniform body of the chewing gum would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
It would also have been obvious to one of ordinary skill in the art to optimize the amounts of PVA, oil, triglyceride and microcrystalline cellulose included in the chewing gum of Urnezis to amounts as claimed, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because as discussed above, Urnezis teaches the polyvinyl acetate is present in an amount of from about 20% to 90% by weight of the gum base, wherein the gum base is present in the chewing gum in an amount of 5% to about 95% by weight of the chewing gum, which are amounts of polyvinyl acetate that overlaps the claimed range of from 35 weight percent to 55 weight percent of the uniform body. Furthermore, as discussed above, Urnezis teaches and provide guidance for hydrophilic softeners/emulsifiers such as triglyceride and triacetin to be present in an amount from 5% to about 35% by weight of the chewing gum base and 0.5% to about 15% by weight of the chewing gum, which are amounts that also overlaps or fall within the claimed range of greater than 8 weight percent for oil and greater than or equal to 5 weight percent for triglyceride of the claimed invention. Additionally, as discussed above, Neergaard provided the guidance for including microcrystalline cellulose in the chewing gum in an amount of 5-45% by weight, which are amounts that overlap the claimed range of from 2 weight percent to 10 weight percent for the microcrystalline cellulose. Thus, as discussed above, the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when 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 similar properties, a prima facie case of obviousness exists. As such, it would have been customary for an artisan of ordinary skill to determine the optimum amounts of PVA, oil such as triglyceride and triacetin, and microcrystalline cellulose, as well as, the optimum dosage of nicotine in the chewing gum to achieve the desired stabilized chewing gum product with improved release properties of nicotine. Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the amounts of PVA, oil such as triglyceride and triacetin, and microcrystalline cellulose in the chewing gum would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Regarding claim 2, Urnezis teaches the gum base of the chewing gum further contain a filler selected from silicate types such as magnesium and aluminum silicate, clay, alumina, talc, titanium oxide, mono-, di- and tri-calcium phosphate, and combinations thereof (column 5, lines 45-50; claim 5). Neergaard teaches the chewing gum further contain a filler selected from talcum and dicalcium phosphate ([0056]-0059] and [0205]).
Regarding claim 3, Urnezis teaches the filler is present in an amount of about 4% to about 50% by weight (column 5, lines 38-50). Neergaard teaches the filler is present in amount of 5-45% by weight ([0056]-0060], [0075]-[0076] and [0205]). Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when 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 similar properties, a prima facie case of obviousness exists. Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the amount of filling the chewing gum would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Regarding claim 4, as discussed above, Neergaard providing the guidance for optimizing dosage amount of nicotine added in the chewing gum to be a dosage amount of 0.5-8 mg, preferably 1-5 mg ([0047]-[0048] and [0118]). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the dosage amount of nicotine added in the uniform body of the chewing gum would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Regarding claim 5, Gao provided the guidance for using tobacco-derived nicotine as the nicotine active agent ([0015]-[0019]).
Regarding claims 6 and 7, as discussed above, Urnezis teaching that the polyvinyl acetate is present in an amount of from about 20% to 90% by weight of the gum base, wherein the gum base is present in the chewing gum in an amount of 5% to about 95% by weight of the chewing gum, which overlap or fall within the claimed ranges of “PVA is present in an amount range from 40 weight percent to 50 weight percent of the uniform body” of claim 6 and “PVA is present in an amount ranging from 43 weight percent to 47 weight percent of the uniform body” of claim 7. Thus, as discussed above, the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when 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 similar properties, a prima facie case of obviousness exists. Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the amount of PVA in the chewing gum would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Regarding claims 9 and 10, Urnezis teaches the hydrophilic softeners/emulsifiers such as triglyceride and triacetin are presents in an amount from 5% to about 35% by weight of the chewing gum base and 0.5% to about 15% by weight of the chewing gum (Urnezis: column 5, lines 20-end to column 6, lines 1-7). Neergaard teaches the chewing gum can contain from 0.1% to 25% by weight of emulsifier such as triglycerides and 0.1% to 25% by weight of plasticizer such as triacetin ([0081]-[0090]). The ranges as taught by Urnezis and Neergaard overlap or fall within the claimed ranges for the oil as recited in claims 9-10. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when 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 similar properties, a prima facie case of obviousness exists. Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the amount of oil in the chewing gum would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Regarding claims 11-12, Urnezis and Neergaard teach the chewing gum contain medium chain triglyceride (Urnezis: column 5, lines 50-54 and Examples 1-4; Neergaard: [0086] and [0090]).
Regarding claim 13, Urnezis teaches the hydrophilic softeners/emulsifiers such as triglyceride and triacetin are presents in an amount from 5% to about 35% by weight of the chewing gum base and 0.5% to about 15% by weight of the chewing gum (Urnezis: column 5, lines 20-end to column 6, lines 1-7). Neergaard teaches the chewing gum can contain from 0.1% to 25% by weight of emulsifier such as triglycerides ([0081]-[0090]). Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when 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 similar properties, a prima facie case of obviousness exists. Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the amount of triglyceride in the chewing gum would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Regarding claim 14, Urnezis teaches the hydrophilic softeners/emulsifiers such as triglyceride and triacetin are presents in an amount from 5% to about 35% by weight of the chewing gum base and 0.5% to about 15% by weight of the chewing gum (Urnezis: column 5, lines 20-end to column 6, lines 1-7). Neergaard teaches the chewing gum can contain from 0.1% to 25% by weight of plasticizer such as triacetin ([0081]-[0090]). Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when 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 similar properties, a prima facie case of obviousness exists. Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the amount of triacetin in the chewing gum would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Regarding claim 15, Urnezis and Neergaard teaches the chewing gum contains flavor oil (Urnezis: column 5, lines 58-end to column 6, lines 1-55; Neergaard: [0094]-[0095]).
Regarding claim 16, as discussed above, Urnezis teaches the chewing gum contains flavor oil in amount of from about 0.2% to about 5% by weight of the chewing gum. Neergaard teaches the chewing gum contains flavor oil in an amount between 0.01 and 5% by weight of the nicotine chewing gum (Neergaard: [0094]-[0095]). Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when 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 similar properties, a prima facie case of obviousness exists. Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the amount of flavor oil in the chewing gum would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Regarding claim 17, Urnezis teaches the chewing gum further contain sweeteners, emulsifiers, acidulants, and antioxidants (Urnezis: column 5, lines 55-64). Neergaard teaches the chewing gum further contain sweeteners, antioxidants, waxes, fats, emulsifiers, acidulants, vitamin, dietary supplement, nutraceutical, and therapeutic agent ([0050]-[0051], [0070]-[0073], [0081]-[0125], and [0184]-[0208]).
Regarding claim 18, as discussed above, Urnezis teaching that the polyvinyl acetate is present in an amount of from about 20% to 90% by weight of the gum base, wherein the gum base is present in the chewing gum in an amount of 5% to about 95% by weight of the chewing gum. As discussed above, Urnezis teaches the hydrophilic softeners/emulsifiers such as triglyceride and triacetin are presents in an amount from 5% to about 35% by weight of the chewing gum base and 0.5% to about 15% by weight of the chewing gum. Furthermore, Neergaard also teaches the chewing gum can contain from 0.1% to 25% by weight of emulsifier such as triglycerides and 0.1% to 25% by weight of plasticizer such as triacetin ([0081]-[0090]). It is noted that the amount of PVA from Urnezis as well as, the amounts of medium chain triglyceride and triacetin as taught by Urnezis and Neergaard, respectively, overlap or fall within the claimed ranges for PVA, medium chain triglyceride and triacetin as recited in claim 18. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when 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 similar properties, a prima facie case of obviousness exists. Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the amounts of PVA, medium chain triglyceride, and triacetin in the chewing gum would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 02/02/2026 have been fully considered but they are not persuasive.
Below is the Examiner’s response to Applicant’s arguments as they pertain to the pending 103 rejection.
Applicant argues that Neergaard teaches the gum base polymers including polyvinyl acetate and vinyl laurate-vinyl acetate copolymer. Thus, Applicant alleges that Neergaard does not teach the gum base polymer consisting of polyvinyl acetate, as recited in claim 1. (Remarks pages 9-10).
In response, the Examiner disagrees. As discussed above in the pending 103 rejection, Urnezis teaches gum base polymer containing only polyvinyl acetate. See 103 rejection, pages 7-8 of this office action, said pages being incorporated herein in its entirety.
As a result, for at least the reason discussed above, claims 1-7 and 9-18 remain rejected as being obvious and unpatentable over the combined teachings Urnezis, Neergaard, and Gao in the pending 103 rejection as set forth in this office action.
Conclusion
No claim is 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.
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/DOAN T PHAN/Primary Examiner, Art Unit 1613