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 statements (IDS) submitted on 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 02/23/2026 in which claim 15 was canceled; and claims 1 and 20 were amended. All the amendments have been thoroughly reviewed and entered.
Claims 1-14 and 16-20 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Withdrawn Objections/Rejections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 Any rejection and/or objection not specifically addressed below is hereby withdrawn.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 1-14 and 16-20 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.
Claims 1 and 20 introduce new matter as the claim recites the limitation: the coating free of nicotine and nicotine derivative. There is no support in the specification for the coating to be free of nicotine and nicotine derivative.
It is noted that while paragraph [0321] 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 [0321] 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 2-14 and 16-19 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 amended claims 1 and 20 at the time of filing of the instant application.
Response to Arguments
Applicant's arguments filed 02/23/2026 have been fully considered but they are not persuasive.
Applicant argues:
“In paragraph [0299], "no" is a determiner and "nicotine or nicotine derivative" is a coordinated noun phrase (i.e., two nouns joined by the conjunction, "or"). Under standard English rules of grammar, a determiner applies to the entire coordinated noun phrase such that the excerpt should be understood as no [nicotine or nicotine derivative], or alternatively, neither nicotine nor nicotine derivative. Additionally, other portions of the specification make clear that nicotine and/or nicotine are not required in the coating. For example, the original specification discloses that, "[i]n 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).” (Remarks, pages 7-8).
In response, the Examiner disagrees. First, it is noted that paragraph [0299] of the specification of this instant application as cited by Applicant is drawn to disclosing about fillers, and thus has nothing pertinent to coating or the "nicotine or nicotine derivative." Furthermore, it is noted that paragraph [0320] in the instant application while drawn to disclosing “coating” that cover the outer surface of the chewing body, said paragraph [0320] does not disclose anything pertaining to nicotine as part of the coating, or lack thereof. Thus, neither paragraph [0299] nor paragraph [0320] in the instant application provide support for the claimed “the coating free of nicotine and nicotine derivatives.”
As discussed above in the standing New Matter rejection, the paragraph in the specification of this instant application that relates to “coating” is paragraph [0321]. It is noted that the reference to “amounts of nicotine or nicotine derivative (including no nicotine or nicotine derivative)” in paragraph [0321] is to the layers that are part of the chewing gum structure and not the coating that surrounds the chewing gum. There is no indication in paragraph [0321] the “layers” pertains to a coating layer surrounding the chewing gum. Rather, it is quite clear in paragraph [0321] 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 [0321] 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 [0321] for “the coating free of nicotine and nicotine derivative” as claimed.
Additionally as discussed above in the standing New Matter rejection, it is reiterated that while paragraph [0321] 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.
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 coating free of nicotine and nicotine derivatives” at the time of filing of the instant application
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-14 and 16-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9-18 of copending Application No. 17223800 (reference application) in view of Neergaard (US 2018/0295856 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the copending application ‘800 significantly overlap with the subject matter of instant claims, i.e., chewing gums comprising a uniform body including, a gum base polymer including, polyvinyl acetate (PVA) in an amount ranging from 35 weight percent to 55 weight percent of the uniform body, oil in an amount between 5 weight percent to 10 weight percent of the uniform body, the oil including, a triglyceride in an amount greater than or equal to 5 weight percent of the uniform body, and triacetin, nicotine or a nicotine derivative dissolved in the triglyceride; and a coating at least partially surrounding the uniform body, wherein the coating is free of nicotine and nicotine derivative, and the nicotine or nicotine derivative is in an amount ranging from 2 mg to 8 mg; and wherein the gum base polymer consist essentially of the PVA.
While the instant claims do not recite microcrystalline cellulose in an amount ranging from 2 weight percent to 10 weight percent of the uniform body, at least a portion of the nicotine or the nicotine derivative dissolved in the triglyceride being absorbed in the microcrystalline cellulose, it would have been obvious to include microcrystalline cellulose in the chewing gum of the instant claims in view of the guidance from Neergaard, which provided the guidance for adding microcrystalline cellulose in chewing gum so as microcrystalline cellulose functions as carrier for nicotine (Neergaard: Abstract; [0003], [0012]-[0063], [0077]-[0102], [0014], [0137], [0146]-[0181], [0186]-[0188]; Example 1 and Table 1; claims 64-71 and 75-76). Neergaard further indicates that the purpose of providing microcrystalline cellulose as the carrier for nicotine is to provide a chewing gum product which improved release properties of the nicotine from the chewing gum (Neergaard: [0008], [0014] and [0025]).
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over copending Application No. 17223800 in view of Neergaard.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 02/23/2026 have been fully considered but they are not persuasive.
Applicant argues “[b]ecause the claims of the present application are currently being prosecuted and, thus, subject to change so as to render the rejections moot, the Applicant requests the Examiner to hold the rejections in abeyance.” (Remarks, page 8).
In response, it is noted that Applicant's request to hold the double patenting rejection in abeyance is not a proper response because a request to hold a matter in abeyance may only be made in response to an objection or requirements as to form (see MPEP 37 CFR 1.111(b) and 714.02).
Accordingly, the double patenting rejection over copending application ‘800 is maintained for reasons of record and pending the filing of a terminal disclaimer.
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) 1-14 and 16-20 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 claims 1 and 20, 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 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 of claims 1 and 20, as well as, does not teach the pH adjuster of claim 20, it would have been obvious to include nicotine as the lipophilic active agent and a pH adjuster 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 the chewing gum core contains a filler in an amount of 5-45% by weight ([0024], [0052]-[0055], [0060] and [0075]-[0076]). Neergaard teaches the chewing gum further contains buffer (a pH adjuster) ([0035]-[0044], [0049]-[0050], [0169]-[0174]). Neergaard teaches the buffer maintains the pH level within certain relatively constant pH values in the oral cavity ([0049]). Neergaard teaches the use of the buffer together with polyvinyl acetate facilitate an advantageous release of buffer matching the released of nicotine, while at the same time obtaining a robust chewing gum which is not dissolved by the buffer ([0043]). Neergaard teaches the chewing gum contains flavor oil ([0094]-[0095]). 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 (an oil), 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 include a pH adjuster 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 Neergaard provided the guidance to do so by teaching that the chewing gum can further contains buffer (a pH adjuster), as such buffer maintains the pH level within certain relatively constant pH values in the oral cavity, as well as, the use of the buffer together with polyvinyl acetate facilitate an advantageous release of buffer matching the released of nicotine, while at the same time obtaining a robust chewing gum which is not dissolved by the buffer. Thus, an ordinary skill artisan would have looked into including a buffer in the gum base core of Urnezis per guidance from Neergaard so as to maintains the pH level within certain relatively constant pH values in the oral cavity upon administration of the chewing gum, and achieve Applicant’s claimed invention with reasonable expectation of success.
It would have been obvious to one of ordinary skill in the art to optimize the amounts of polyvinyl acetate, oil and filler 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 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 of claim 1, as well as overlaps the claimed range of from 40 weight percent to 55 weight percent of the uniform body of claim 20. 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 ranges of from 5 weight percent to 20 weight percent for oil of claim 1 and from 5 weight percent to 10 weight percent for oil of claim 20. Additionally, as discussed above, Urnezis teaches the chewing gum contains a filler in an amount of about 4% to about 50% by weight., which are amounts that overlap the claimed range of less than or equal to 10 weight percent for filler of claim 20. 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 polyvinyl acetate, oil, and filler, as well as, the optimum dosage of nicotine in the chewing gum, respectively of claims 1 and 20, to achieve the desired 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 polyvinyl acetate, oil, and filler 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, 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 from 5 weight percent to 10 weight percent for oil.
Regarding claim 3, as discussed above, Urnezis and Neergaard teach the chewing gum contains triacetin.
Regarding claim 4, as discussed above, Urnezis and Neergaard teach the chewing gum contain medium chain triglyceride.
Regarding claims 5-7, as discussed above, Neergaard teaches and provide guidance for the chewing gum to further contains buffer (a pH adjuster) ([0035]-[0044], [0049]-[0050], [0169]-[0174]). Neergaard teaches the buffer maintains the pH level within certain relatively constant pH values in the oral cavity ([0049]). Neergaard teaches the use of the buffer together with polyvinyl acetate facilitate an advantageous release of buffer matching the released of nicotine, while at the same time obtaining a robust chewing gum which is not dissolved by the buffer ([0043]). Neergaard teaches suitable buffer include sodium carbonate, sodium bicarbonate, and combination thereof ([0038]-[0039], [0042], and [0169]-[0174]).
Regarding claim 8, Neergaard teaches and provide guidance for the nicotine active agent to include tobacco-derived nicotine ([0042]-[0043] and [0046]).
Regarding claim 9, Urnezis and Neergaard both teach the chewing gum can further contains vitamin E (tocopherol) (Urnezis: column 3, lines 1-12 and 40-41 and column 4, lines 19-23; Neergaard: [0196]-[0197]).
Regarding claim 10, Urnezis and Neergaard teaches the chewing gum contains a flavor oil (Urnezis: column 5, lines 58-end to column 6, lines 1-55; Neergaard: [0094]-[0095]).
Regarding claim 11, as discussed above, Urnezis teaches the chewing gum further contain a filler in an amount of about 4% to about 50% by weight (column 5, lines 38-50). Neergaard the chewing gum core contains a filler in an amount of 5-45% by weight ([0024], [0052]-[0055], [0060] and [0075]-[0076]). 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 filler 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 12, Urnezis teaches the filler is 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 filler is selected from magnesium- and calcium carbonate, sodium sulphate, ground limestone, silicate compounds such as magnesium- and aluminum silicate, kaolin and clay, aluminum oxide, silicium oxide, talc, titanium oxide, mono-, di- and tri-calcium phosphates, cellulose polymers, such as wood, starch polymers, fibers and combinations thereof (Neergaard: [0053]-[0060]).
Regarding claims 13 and 14, as discussed above, Urnezis teaching that the polyvinyl acetate (PVA) 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. It is noted that the amounts of PVA as taught by Urnezis overlap or fall within the claimed ranges as recited in claims 13 and 14. 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 polyvinyl acetate 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 16, Urnezis and Neergaard teach the chewing gum further contains a sweetener (Urnezis: column 5, lines 58-64 and columns 6-7; Neergaard: [0096]-[0103] and [0184]).
Regarding claims 17-19, Urnezis teaches a hard coating for a chewing gum contains a sweetener and gum arabic, carboxymethyl cellulose, hydroxymethyl cellulose, alginate, locust bean gum, guar gum, or gum tragacanth (column 4, lines 30-50; column 7, lines 30-39; column 8, lines 30-end; column 9, lines 1-7). Urnezis teaches the hard coating can further a flavoring agent (columns 7-10). Neergaard teaches the nicotine chewing gum core coated with an outer coating that is hard coating or a soft coating (Neergaard: [0161] and [0209]).
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 02/23/2026 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 10-11 of this office action, said pages being incorporated herein in its entirety.
As a result, for at least the reason discussed above, claims 1-14 and 16-20 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