DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the claims and applicant arguments/remarks, filed 11/06/2025, 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 Claims 14-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and inventions, there being no allowable generic or linking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Any rejection or objection not reiterated in this action is withdrawn.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 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 13 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 13 (dependent on claim 1) discloses the compositions comprising: 30-50 wt% of the thermoplastic binding system; 5-75 wt% of a filler; 0.1-5 wt% of a sweetener; 0.5-7.5 wt% of a salt; and 1-10 wt% of an active agent that is not clear, because the amount of mixing compounds (e.g., 30+75+0.1+0.5+1 wt%) is more than 100 wt%. Clarification is required.
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 rquried.
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.
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, maltitiol, 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, it is the examiner’s positions 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 also 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, xantham gum, polyvinylpyrolidone, 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 (1) claims 1-2, 4, 7, 11, 14, 16, 19 of copending Application No. 17/205,800; (2) claims 1-13 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 applications and would be covered by any patent granted on that copending application since the referenced copending applications 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. 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) and therefore are more specific. This is a provisional obviousness-type double patenting rejection, because the conflicting claims have not in fact been patented.
In response to the applicant’s argument that said copending applications do not disclose the use of 30-50 wt% of thermoplastic binder systems, it is noted that said copending applications disclose the compositions comprising the same compounds, and also disclose the use of 30 wt% of a combination of binders (e.g., 17/205,800), or less than 50% of thermoplastic binder system (e.g., 17/836,661). 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.
Response to Arguments
Applicant's arguments, filed 11/062025, have been fully considered, but they are moot in view of amendments to the claims. New rejections have been added to the record to address newly introduced amendments and to clarify the position of the examiner. 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.
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.
Correspondence
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