DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/14/2026, has been entered.
Status of Application
Receipt of the amendments to the claims and applicant arguments/remarks, filed 04/14/2026 (Response after Final Action), is acknowledged.
Applicant has previously elected the invention of Group I, claims 1-13, the drawn to compositions comprising thermoplastic polymer, plasticizer, flavoring agent, and active ingredient.
Claims 1-5, 7, 9-10, 13-21 are pending in this action. Claim 6, 8, 11, 12 have been cancelled previously. Claims 1, 13, 21 have been amended. Claims 14-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and inventions, there being no allowable generic or linking claim. Claims 1-5, 7, 9-10, 13, 21 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
This application, filed December 9, 2019, does not claim benefit of a domestic or foreign priority.
Claim Objections
Claims 13, 21 are objected to because of the following informalities: Claim 13 comprises the typographic error “comprising: about 30 to about 50%” that needs to be corrected to “comprising: from about 30 to about 50%” (see claims 1, 10). Similar is applied to other constituents recited in claim 13, as well as to claim 21. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-5, 7, 9-10, 13, 21 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 pre-AIA the applicant regards as the invention.
Newly amended claim 1 recites the term "about" that is a relative term, which renders the claim indefinite. This term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Similar is applied to claims 4, 10, 13, 21. Clarification is required.
As stated previously, claim 13 refers to “composition”, wherein several elements are characterized by their assumed function (e.g., filler, sweetener, etc.) and not by the structure essential for said composition. This claim is unclear and indefinite, because the function of a particular compound may change and/or depend on conditions. In specification, the applicant provides a support to this point stating that some fillers (e.g., mannitol, xylitol, sorbitol) can be employing as sweeteners (see Para. 0076, 0077). Therefore, given that the scope of the claims is not limited by claim language that does not limit a claim to a particular structure (MPEP 2111.04), one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. Clarification is required.
In response to the applicant’s argument that said functional terms are well understood/known in the field, it is noted that the main purpose of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent; and to provide a clear measure of what the applicant regards as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability. MPEP 2173. To this point, it is noted that it is well known in the field that properties of multicomponent systems (e.g., compositions/products) depend on compounds included as well as on concentrations and/or distribution of said compounds that define the network of intermolecular interactions, and thereby physical and chemical properties of the system/composition/product. Claiming a result without reciting what materials produce that result is the epitome of an indefinite claim. Such a claim fails to delineate with any reasonable certainty the requirements of the formulation. See Forest Labs., Inc. v. Teva Pharms. USA, Inc. 2017 U.S. App. LEXIS 24877. Further, it is noted that “Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore, the examiner maintains the position that clarification of compounds to be included into the claimed product is required.
Claims 2-3, 5, 7, 9 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
Claim Rejections - 35 USC § 103 - MAINTAINED
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.
Claims 1-5, 7, 9-10, 13, 21 are rejected under 35 U.S.C. 103 being unpatentable over Gao et al., US 2014/0332013 (cited in IDS; hereinafter referred to as Gao), in view of Marshall et al., US 2015/0101627 (cited in IDS; hereinafter referred to as Marshall).
Gao teaches oral products that can be free of tobacco (Claim 9; Para. 0009, 0025 as applied to claims 1, 21), can have a variety of different shapes, e.g., disk, shield, rectangle, square, triangle, oval; and may include:
(i) 0.1-5 wt% of a mouth-soluble binder, e.g., hydroxypropyl cellulose, hydroxypropyl methylcellulose, pullulan, xanthan gum, polyvinylpyrrolidone, polyethylene oxide, maltodextrin, or a combination thereof (i.e., thermoplastic polymers; Claim 5; Para. 0008, 0032, 0051, 0052 as applied to claims 1-3, 5, 13, 21);
(ii) 0.5-20 wt% of a plasticizer, e.g., propylene glycol, glycerine, or combination thereof (Para. 0011, 0074 as applied to claims 1, 7, 21);
(iii) sweeteners, e.g., sorbitol, xylitol, mannitol, maltitol, isomalt, erythritol (Para. 0011 as applied to claims 7, 13) identified in the instant application as plasticizers;
(iv) 0.1-6 mg of nicotine or its salt (Claim 18; Para. 0008, 0025, 0055 as applied to claims 1, 9, 10, 13, 21);
(v) flavorants, sweeteners, fillers (Para. 0063 as applied to claim 13).
Gao teaches that said binder provides the oral product with a modified texture and flavor release profile, and also teaches that said oral product provides a tobacco-like flavor experience and favorable tactile experience (Para. 0008).
Marshall teaches oral compositions that can be provided in any predetermined shape or form, e.g., as a pill, pellet, tablet, coin, bead, etc. (Para. 0077) and may include: (i) 25-40 wt% of a binder material that may include xanthan gum, gum arabic, or combination thereof (i.e., thermoplastic polymer; Para. 0047); (ii) such sugar alcohol as isomalt, erythritol, polyglycitol, maltitol, xylitol, maltitol, sorbitol in an amount of 45 wt% that can be used for controlling sweetness, texture and mouthfeel (i.e., plasticizer; Para. 0048, 0058); (iii) 0.5-5 wt% of glycerine (i.e., plasticizer; Para. 0010, 0053); (iv) 0.4-8 wt% of a salt; (v) 0.3-10 wt% of a flavorant (Para. 0054); and (vi) comprise no tobacco, but only tobacco derived nicotine, e.g., in an amount of 0.1-5 wt% (Para. 0057; Examples 5, 11-17).
Therefore, the examiner maintains the position that the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed, because every element of the invention has been taught by the teaching of the references cited. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare oral tobacco-free products comprising a flavoring agent and an actine ingredient (e.g., nicotine) in combination with a thermoplastic binding system comprising a thermoplastic polymer(s) and a plasticizer(s) as taught by Gao and Marshall, because the cited prior art teaches that said approach would provide oral tobacco-free products that can be prepared in different shapes, having controllable/desired texture and flavor release profile.
Regarding the concentrations as instantly claimed, it is noted that one of ordinary skill in the art at would have recognized the concentration of each ingredient as result-effective variables that determine the composition’s efficacy and physical properties. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Furthermore, optimization within prior art conditions or through routine experimentation does not support patentability absent comparative evidence of criticality of the claimed range. MPEP § 2144.05 (II). Regarding the claim 4, it is noted that the cited prior art teaches formulations comprising the same components. Thus, it is expected that since the prior art is comprised of the same components, the same beneficial properties and effects would also be provided.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Rudolph et al., US 2011/0129517 (cited in IDS) – teaches tablettable chewing gums comprising nicotine or its salt; povidone/polyvinylpyrrolidone, hydroxypropyl cellulose, hydroxypropyl methylcellulose, arabic gum, xanthan gum (i.e., thermoplastic polymer) in combination with glycerine/glycerol, polyethylene glycol, propylene glycol, maltitol, sorbitol, mannitol, xylitol, erythritol (i.e., 0.1-5 wt% of a plasticizer), flavors, filler.
Bruun, US 2019/0255035 - teaches nicotine pouches comprising nicotine (i.e., active ingredient); polyvinylpyrrolidone, xanthan gum, polyvinylpyrrolidone, polyvinyl alcohol (i.e., thermoplastic polymer); sorbitol, erythritol, xylitol, maltitol, mannitol, isomalt, polyethylene glycols, propylene glycol (i.e., plasticizer); sweeteners, flavors; and that is free of tobacco.
Cantrell et al., US 2013/263870 (cited in IDS) - teaches tobacco compositions comprising gum arabic, xanthan gum, maltodextrin, hydroxypropyl cellulose, hydroxypropyl methylcellulose (i.e., thermoplastic polymer) in combination with isomalt, erythritol, maltitiol, mannitol, xylitol, glycerine, propylene glycol (i.e., plasticizer), salt, flavorant, fillers.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5, 7, 9-10, 13, 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-9, 13 of copending Application No. 17/836,661.
Although the conflicting claims are not identical, they are not patentably distinct from each other, because the subject matter claimed in the instant application is fully disclosed in the referenced copending application and would be covered by any patent granted on that copending application since the referenced copending application and the instant application are claiming common subject matter, as follows: A composition comprising: (1) hydroxypropyl cellulose, hydroxypropyl methylcellulose, maltodextrin, pullulan, xanthan gum, gum arabic (i.e., thermoplastic polymer); (2) isomalt, sorbitol, erythritol, maltitol, mannitol, xylitol, glycerin, propylene glycol (i.e., plasticizers); (3) flavoring and active agents/nicotine component; (4) sweeteners, salts, fillers; and (5) can be free of tobacco material. Further, it is noted that the referenced copending application teaches (i) compositions comprising the same compounds, (ii) the use of less than 50 wt% of thermoplastic binder system; and (iii) the use of a plasticizer in an amount of 1-50 wt%. In the present case, copending application claims are merely broader than instant claims that include additional limitation (i.e., 30-50 wt% of binder system, 20-30 wt% of a plasticizer in a binder system) and therefore are more specific. Therefore, the examiner maintains the position that claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in said copending application. This is a provisional obviousness-type double patenting rejection, because the conflicting claims have not in fact been patented. The non-statutory double patenting rejection over application No. 17/205,800 (abandoned) has been withdrawn.
Response to Arguments
Applicant's arguments, filed 04/14/2026, have been fully considered, but they were not found to be persuasive for the reasons set forth above. Additional examiner comments are set forth next.
In response to the applicant’s argument that the cited prior art does not teach amounts of plasticizers as newly claimed, it is noted that newly amended claim 1 discloses compositions comprising (i) a thermoplastic binder system in an amount of 30-50 wt% by weight of composition; and (ii) a plasticizer in an amount of 20-30 wt% of thermoplastic binder system. Therefore, it is expected that the plasticizer(s) is present in the claimed compositions in an amount of 6-15 wt% by the weight of compositions. The cited prior teaches compositions comprising plasticizers in an amount of 0.5-20 wt% (e.g., Gao) or 0.5-5 wt% (e.g., Marshall). To this point, it is noted that “Product claims with numerical ranges, which overlap prior art ranges were held to have been obvious under 35 USC 103.” In re Wertheim 191 USPQ 90 (CCPA 1976); In re Malagari 182 USPQ 549 (CCPA 1974); In re Fields 134 USPQ 242 (CCPA 1962); In re Nehrenberg 126 USPQ 383 (CCPA 1960). More particularly, “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, the applicant’s argument is not persuasive.
Applicant is advised to clarify the claim language, the structure of the claimed compositions and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in condition for allowance. Further, as stated previously, withdrawn process claims that are not commensurate in scope with an allowable product claim will not be rejoined. In order for rejoinder to occur, applicant is advised that the process/method claims should be amended during prosecution to require the limitations of the product claims. MPEP § 821.04.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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